HIV Infections
Conditions
Keywords
Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases, Immunologic Deficiency Syndromes, Immune System Diseases, Immunologic Factors, Physiological Effects of Drugs
Brief summary
This is an open-label, multicenter, randomized phase 1 study to evaluate the safety and immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV trimer mRNA. These trimers are based on the BG505 MD39 native-like trimer reported in Steichen et al. Immunity 2016. The primary hypothesis is that the BG505 MD39.3 soluble and membrane-bound trimer mRNA vaccines will be safe and well-tolerated among HIV-uninfected individuals and will elicit autologous neutralizing antibodies.
Detailed description
Participants will receive BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA or BG505 MD39.3 gp151 CD4KO mRNA, at doses of 100 mcg or 250mcg, administered via intramuscular (IM) injections into the deltoid muscle. Participants will be evaluated for safety and immune responses through blood and lymph node fine-needle aspiration collection at specified timepoints throughout the study. A dose escalation plan will be implemented, whereby sentinel safety groups for each of the three low-dose groups in Part A would be enrolled and evaluated for safety 2 weeks after the first vaccination. If safety criteria are met, then enrollment of the Part B sentinel safety groups and the remainder of the Part A participants would commence. Safety for the sentinel groups in Part B will be assessed after the first vaccination prior to full enrollment of Part B. In addition, standard safety evaluations will occur routinely throughout the trial.
Interventions
BIOLOGICALBG505 MD39.3 mRNA
Administered by IM injection
BIOLOGICALBG505 MD39.3 gp151 mRNA
Administered by IM injection
BIOLOGICALBG505 MD39.3 gp151 CD4KO mRNA
Administered by IM injection
Sponsors
National Institutes of Health (NIH)
Department of Health and Human Services
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly. 2. 18-55 years old, inclusive, on day of enrollment. 3. Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit. 4. Agrees not to enroll in another study of an investigational agent during participation in the trial. 5. In good general health according to the clinical judgement of the site investigator. 6. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator. 7. Assessed as low risk for HIV acquisition per low risk guidelines, agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed for 6 months or longer. 8. Hemoglobin * Greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth * Greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months * Greater than or equal to 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months * For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth 9. White blood cell (WBC) count \> 3,500/mm3 10. Platelets ≥125,000 /mm3 11. Alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) based on the institutional normal range 12. Serum creatinine ≤1.1 x ULN based on the institutional normal range 13. Negative results for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). 14. Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected. 15. Negative for Hepatitis B surface antigen. 16. For a volunteer capable of becoming pregnant: * Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use effective means of birth control from at least 21 days prior to enrollment through 3 months after their third vaccination timepoint * Has negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to study product administration on day of enrollment.
Exclusion criteria
1. Volunteer who is breast-feeding or pregnant. 2. Hypertension that is not well controlled. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently \< 140 mm Hg systolic and \< 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be \< 140 mm Hg systolic and \< 90 mm Hg diastolic at enrollment. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment. 3. Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes). 4. Previous or current recipient of an investigational HIV vaccine (previous placebo recipients are not excluded). 5. Acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) on the day of the first vaccination. Participants meeting this criterion may be rescheduled within the enrollment window period. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator. 6. Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatologic condition; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses \< 60 mg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment). 7. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval. 8. Receipt of any of the following: * Within 4 weeks prior to enrollment: * Any licensed live, attenuated vaccine * Any emergency use authorized (EUA) or licensed mRNA-based SARS-CoV-2 vaccine * Within 2 weeks prior to enrollment: * Any licensed killed/subunit/inactivated vaccine * Any EUA or licensed adenoviral-vectored or protein SARS-CoV-2 vaccines Receipt of any SARS-CoV-2 vaccination series should be completed 4 weeks prior to enrollment when possible; however, exceptions may be made by approval of the HVTN 302 PSRT. 9. Initiation of antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval. 10. Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment. 11. History of serious reaction (eg, hypersensitivity, anaphylaxis) to any vaccine or any component of the study vaccine. 12. History of myocarditis and/or pericarditis. 13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema. 14. Idiopathic urticaria within the past year. 15. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions). 16. Seizure disorder; febrile seizures as a child or seizures secondary to alcohol withdrawal more than 5 years ago are not exclusionary. 17. Asplenia or functional asplenia. 18. Active duty and reserve US military personnel. 19. Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, or cancer that, in the clinical judgement of the site investigator, has a potential for recurrence (excluding basal cell carcinoma). 20. Asthma is excluded if the participant has ANY of the following: * Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR * Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR * Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR * Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist \[LABA\]); OR * Uses more than one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval. 21. A participant with a history of an immune-mediated disease, either active or remote. Not exclusionary: 1) remote history of Bell's palsy (\>2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment. 22. Immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | 2 weeks after the 3rd vaccination timepoint (M6.5) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through Month 12 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | Measured through Month 12 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Measured through Month 12. | There were no adverse events of special interest reported by any participant. |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through Month 12 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through Month 12. | There were no early study terminations associated with an AE or reactogenicity reported by any participant. |
| Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | 2 weeks after the 3rd vaccination timepoint (M6.5) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N. |
| Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Measured through 7 days after each vaccine dose | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Measured through 7 days after each vaccine dose | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 7 days after each vaccine dose | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Chemistry and Hematology Laboratory Measures - ALT in U/L | Measured during Screening, Days 8, 64, 176 and 225 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population |
| Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Measured during Screening, Days 8, 64, 176 and 225 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population |
| Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Measured during Screening, Days 8, 64, 176 and 225 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Measured during Screening, Days 8, 64, 176 and 225 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population |
| Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Measured during Screening, Days 8, 64, 176 and 225 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population |
| Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Measured during Screening, Days 8, 64, 176 and 225 | The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | 30 days following each injection | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | 30 days following each injection | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N. |
| Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12) | Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI\* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI\*), 2) MFI\* \> 3x(Visit 2 MFI\* ), and 3) MFI \> 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI\* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank\>5000 MFI), high baseline (Baseline\>6500 MFI\*) are excluded. MFI\* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay. |
| Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12) | Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI\* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI\*), 2) MFI\* \> 3x(Visit 2 MFI\* ), and 3) MFI \> 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI\* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank\>5000 MFI), high baseline (Baseline\>6500 MFI\*) are excluded. MFI\* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay. |
| Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | 2 weeks after the 3rd vaccination (M6.5) | Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands |
| Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | 2 weeks after the 3rd vaccination (M6.5) | Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands |
| Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A, Group 1: Treatment 100 mcg of BG505 MD39.3 mRNA | 18 |
| Part A, Group 2: Treatment 100 mcg of BG505 MD39.3 gp151 mRNA | 19 |
| Part A, Group 3: Treatment 100 mcg of BG505 MD39.3 gp151 CD4KO mRNA | 17 |
| Part B, Group 4: Treatment 250 mcg of BG505 MD39.3 mRNA | 18 |
| Part B, Group 5: Treatment 250 mcg of BG505 MD39.3 gp151 mRNA | 18 |
| Part B, Group 6: Treatment 250 mcg of BG505 MD39.3 gp151 CD4KO mRNA | 18 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Extended Follow up | 1 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Other: participant did not specify reason | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Part A, Group 2: Treatment | Part A, Group 3: Treatment | Part B, Group 4: Treatment | Part A, Group 1: Treatment | Part B, Group 5: Treatment | Part B, Group 6: Treatment | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 35 years | 31 years | 27 years | 25.5 years | 26 years | 30 years | 28.5 years |
| Age, Customized 18 - 20 years | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 12 Participants |
| Age, Customized 21 - 30 years | 4 Participants | 7 Participants | 12 Participants | 10 Participants | 11 Participants | 7 Participants | 51 Participants |
| Age, Customized 31 - 40 years | 10 Participants | 6 Participants | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 32 Participants |
| Age, Customized 41 - 50 years | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 10 Participants |
| Age, Customized Over 50 years | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 8 Participants | 3 Participants | 3 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 16 Participants | 16 Participants | 10 Participants | 15 Participants | 15 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 12 Participants | 14 Participants | 18 Participants | 15 Participants | 84 Participants |
| Region of Enrollment US | 19 Participants | 17 Participants | 18 Participants | 18 Participants | 18 Participants | 18 Participants | 108 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 9 Participants | 12 Participants | 7 Participants | 7 Participants | 52 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 9 Participants | 6 Participants | 11 Participants | 11 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 | 0 / 17 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 18 / 18 | 19 / 19 | 17 / 17 | 18 / 18 | 18 / 18 | 18 / 18 |
| serious Total, serious adverse events | 1 / 18 | 1 / 19 | 1 / 17 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures - ALT in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time frame: Measured during Screening, Days 8, 64, 176 and 225
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -Screening | 15 U/L |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V3 - 1 week post-vaccination 1 | 14 U/L |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V7 - 1 week post-vaccination 2 | 13 U/L |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 12 U/L |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V7 - 1 week post-vaccination 2 | 17 U/L |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -Screening | 17 U/L |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V3 - 1 week post-vaccination 1 | 16 U/L |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 13 U/L |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V3 - 1 week post-vaccination 1 | 17 U/L |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V7 - 1 week post-vaccination 2 | 17 U/L |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -Screening | 17 U/L |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 13 U/L |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -Screening | 15 U/L |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V3 - 1 week post-vaccination 1 | 14.5 U/L |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V7 - 1 week post-vaccination 2 | 14 U/L |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 28 U/L |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 12 U/L |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V7 - 1 week post-vaccination 2 | 15 U/L |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V3 - 1 week post-vaccination 1 | 14.5 U/L |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -Screening | 19 U/L |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 13 U/L |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V7 - 1 week post-vaccination 2 | 22 U/L |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -Screening | 23 U/L |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V3 - 1 week post-vaccination 1 | 20 U/L |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - ALT in U/L | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 19 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time frame: Measured during Screening, Days 8, 64, 176 and 225
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0.83 mg/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0.8 mg/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0.77 mg/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -Screening | 0.82 mg/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 1 mg/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0.95 mg/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -Screening | 0.91 mg/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0.9 mg/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -Screening | 0.87 mg/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0.91 mg/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0.86 mg/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0.84 mg/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0.83 mg/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0.76 mg/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0.76 mg/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -Screening | 0.79 mg/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0.8 mg/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0.86 mg/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -Screening | 0.91 mg/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0.9 mg/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0.91 mg/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0.81 mg/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0.82 mg/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0.87 mg/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL) -Screening | 0.86 mg/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time frame: Measured during Screening, Days 8, 64, 176 and 225
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 13.7 g/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 13.8 g/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -Screening | 14.55 g/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 13.7 g/dL |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 13.5 g/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 13.8 g/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 13.5 g/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -Screening | 13.7 g/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 13.4 g/dL |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 13.65 g/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 13.7 g/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 13.7 g/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 13.9 g/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 13.4 g/dL |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -Screening | 14.2 g/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 13.1 g/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -Screening | 14.1 g/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 13.85 g/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 12.9 g/dL |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 12.9 g/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 13.7 g/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -Screening | 14.75 g/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 13.7 g/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 14.1 g/dL |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 13.8 g/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -Screening | 14.15 g/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 13.2 g/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 13.8 g/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 13.25 g/dL |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 14 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time frame: Measured during Screening, Days 8, 64, 176 and 225
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.14 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 2.17 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.04 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -Screening | 0.04 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.16 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -Screening | 2.12 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -Screening | 0.08 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.04 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 1.79 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 2.02 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 3.9 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 3.09 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -Screening | 4.26 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.1 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.04 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.05 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 3.5 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 3.54 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.11 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 2.02 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 3.84 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 2.08 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 3.07 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 3.76 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 3.18 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.06 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.05 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.05 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -Screening | 0.11 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.12 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.13 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.05 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.15 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 1.92 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.11 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 2.1 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -Screening | 1.93 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -Screening | 0.04 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 1.86 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -Screening | 3.39 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -Screening | 1.86 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.15 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.05 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.05 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 3.07 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.13 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 3.6 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 3.67 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 3.53 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.13 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 1.85 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -Screening | 3.9 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -Screening | 0.05 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 1.85 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 1.85 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -Screening | 0.12 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.04 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 1.78 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.18 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.05 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 2.08 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 1.94 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.04 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.17 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.05 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.05 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.04 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 2.01 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -Screening | 4.13 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.11 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 3.33 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 3.2 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 3.37 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -Screening | 2.05 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 3.01 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.13 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.16 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -Screening | 0.05 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -Screening | 0.11 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 2.1 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.05 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -Screening | 1.79 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 1.9 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.05 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.05 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -Screening | 0.14 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.21 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.2 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.2 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.18 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 1.9 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 2.02 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 2.13 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -Screening | 3.31 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 3.44 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 2.73 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 2.8 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 2.73 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -Screening | 0.04 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.04 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -Screening | 3.22 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 1.89 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 3.42 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 1.95 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 2.04 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 1.87 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.11 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/Cubic mm) -Screening | 1.78 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -Screening | 0.04 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.14 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.19 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.19 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Eosinophils (1000 cells/Cubic mm) -Screening | 0.12 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 0.04 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 0.04 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 0.03 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 0.04 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 3.18 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 2.86 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 3.59 1000 cells/Cubic mm |
Primary
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time frame: Measured during Screening, Days 8, 64, 176 and 225
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 6.17 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -Screening | 7.05 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 5.59 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -Screening | 257 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 271 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 5.99 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 290 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 6.45 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 251 1000 cells/Cubic mm |
| Part A, Group 1: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 267.3 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 277 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 5.79 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 277 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -Screening | 6.23 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 285.5 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -Screening | 267 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 6.21 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 6.49 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 269 1000 cells/Cubic mm |
| Part A, Group 2: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 6.7 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 6.7 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -Screening | 284 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -Screening | 6.76 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 6.1 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 275 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 287 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 279 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 5.65 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 267 1000 cells/Cubic mm |
| Part A, Group 3: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 6.64 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 295 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 5.91 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -Screening | 7.1 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 6.17 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 6.64 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 6 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -Screening | 276 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 283.5 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 279 1000 cells/Cubic mm |
| Part B, Group 4: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 271.5 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 5.71 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 256.5 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 5.49 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 5.7 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 291 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 262 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 6.09 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 271 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -Screening | 5.82 1000 cells/Cubic mm |
| Part B, Group 5: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -Screening | 257.5 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 6.26 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -Screening | 6.25 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 281 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3 | 281 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 5.43 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -Screening | 259 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 274 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3 | 5.9 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2 | 278 1000 cells/Cubic mm |
| Part B, Group 6: Treatment | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1 | 6.14 1000 cells/Cubic mm |
Primary
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Time frame: 2 weeks after the 3rd vaccination timepoint (M6.5)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 5 log10(titer) |
| Part A, Group 1: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 5 log10(titer) |
| Part A, Group 2: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 15.5 log10(titer) |
| Part A, Group 2: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 5 log10(titer) |
| Part A, Group 3: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 35.4 log10(titer) |
| Part A, Group 3: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 9.6 log10(titer) |
| Part B, Group 4: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 5 log10(titer) |
| Part B, Group 4: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 5 log10(titer) |
| Part B, Group 5: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 73.4 log10(titer) |
| Part B, Group 5: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 22.5 log10(titer) |
| Part B, Group 6: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 68.6 log10(titer) |
| Part B, Group 6: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 24.8 log10(titer) |
Primary
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm
Time frame: Measured during Screening, Days 8, 64, 176 and 225
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V7 - 1 week post-vaccination 2 | 1 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 1 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V3 - 1 week post-vaccination 1 | 1 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 1: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 1 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 1 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 1 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 1 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 2: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 2 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 2 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 1 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 1 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part A, Group 3: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V3 - 1 week post-vaccination 1 | 1 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V7 - 1 week post-vaccination 2 | 1 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 1 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 1 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 4: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V7 - 1 week post-vaccination 2 | 1 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V3 - 1 week post-vaccination 1 | 1 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 5: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2 | 1 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | WBC (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -V3 - 1 week post-vaccination 1 | 1 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V7 - 1 week post-vaccination 2 | 1 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | ALT (U/L) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Eosinophils (1000/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -V3 - 1 week post-vaccination 1 | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part B, Group 6: Treatment | Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils | Creatinine (mg/dL) -Screening | 0 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Time frame: 30 days following each injection
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 8 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 8 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 12 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 5 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 11 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 4 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 12 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 3 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 3 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 5 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 3 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 10 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 4 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 4 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 10 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 30 days following each injection
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 2 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 10 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 6 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 3 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 9 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 5 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 9 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 4 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 3 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 6 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 9 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 10 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 5 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 3 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 4 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 5 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 8 Participants |
Primary
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
There were no adverse events of special interest reported by any participant.
Time frame: Measured through Month 12.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after each vaccine dose
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 10 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 8 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 7 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 10 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 9 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 4 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 8 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 8 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 1 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 8 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 9 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 10 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 8 Participants |
Primary
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after each vaccine dose
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 15 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 2 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 2 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 17 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 16 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 4 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 13 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 4 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 15 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 13 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 12 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 12 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 16 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 16 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 14 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 13 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 15 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 14 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 17 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 12 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 12 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 14 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 4 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 3 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 2 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 3 Participants |
Primary
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: Measured through Month 12
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 9 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 9 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 8 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 6 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 5 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 3 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: Measured through Month 12
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after each vaccine dose
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 6 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 11 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 5 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 10 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 14 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 14 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 4 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 4 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 3 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 11 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 7 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 10 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 8 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 2 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 5 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 8 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 7 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 5 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 4 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 5 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 16 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 4 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 5 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 7 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 3 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 11 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 10 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 9 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 13 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 3 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 6 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 7 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part A, Group 2: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 13 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 17 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 7 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 7 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 10 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 6 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 9 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 5 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 3 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 6 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 8 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 2 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 5 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 7 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 4 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 7 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 6 Participants |
| Part A, Group 3: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 5 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 3 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 7 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 3 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 11 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 8 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 7 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 4 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 6 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 6 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 7 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 2 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 11 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 17 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 11 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 5 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 11 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 7 Participants |
| Part B, Group 4: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 4 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 12 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 8 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 9 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 7 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 8 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 8 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 10 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 10 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 5 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 4 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 5 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 6 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 8 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 4 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 3 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 9 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 11 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 2 Participants |
| Part B, Group 5: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 3 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 12 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 8 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 10 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 9 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 7 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 8 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 6 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 4 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 5 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 6 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 7 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 7 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 7 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 4 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 13 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 2 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 9 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 7 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 2 Participants |
| Part B, Group 6: Treatment | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
Primary
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Time frame: Measured through Month 12.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Treatment | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
Primary
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: Measured through Month 12
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Adverse event | 2 Participants |
| Part A, Group 1: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 0 Participants |
| Part A, Group 1: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 16 Participants |
| Part A, Group 2: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 2 Participants |
| Part A, Group 2: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 0 Participants |
| Part A, Group 2: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Adverse event | 1 Participants |
| Part A, Group 2: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 16 Participants |
| Part A, Group 3: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 17 Participants |
| Part A, Group 3: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 0 Participants |
| Part A, Group 3: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Adverse event | 0 Participants |
| Part B, Group 4: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Adverse event | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 9 Participants |
| Part B, Group 4: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 1 Participants |
| Part B, Group 4: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 7 Participants |
| Part B, Group 5: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 3 Participants |
| Part B, Group 5: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 14 Participants |
| Part B, Group 5: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 0 Participants |
| Part B, Group 5: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Adverse event | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 0 Participants |
| Part B, Group 6: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 1 Participants |
| Part B, Group 6: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 16 Participants |
| Part B, Group 6: Treatment | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Adverse event | 1 Participants |
Primary
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Time frame: 2 weeks after the 3rd vaccination timepoint (M6.5)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 11 Participants |
| Part A, Group 2: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 7 Participants |
| Part A, Group 3: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 12 Participants |
| Part A, Group 3: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 8 Participants |
| Part B, Group 4: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 12 Participants |
| Part B, Group 5: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 10 Participants |
| Part B, Group 6: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M6.5 | 14 Participants |
Secondary
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
Time frame: 2 weeks after the 3rd vaccination (M6.5)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part A, Group 1: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 0.3 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 2: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part A, Group 3: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 0.3 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 0.2 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 4: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 0.3 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 0.4 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 5: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 0.5 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 0.1 Percent T-cells expressing cytokines |
| Part B, Group 6: Treatment | Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 0.3 Percent T-cells expressing cytokines |
Secondary
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Time frame: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 log10(titer) |
| Part A, Group 1: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 5 log10(titer) |
| Part A, Group 2: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 log10(titer) |
| Part A, Group 2: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 27.6 log10(titer) |
| Part A, Group 2: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 5 log10(titer) |
| Part A, Group 2: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 5 log10(titer) |
| Part A, Group 3: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 5 log10(titer) |
| Part A, Group 3: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 49 log10(titer) |
| Part A, Group 3: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 log10(titer) |
| Part A, Group 3: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 12.7 log10(titer) |
| Part B, Group 4: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 5 log10(titer) |
| Part B, Group 4: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 log10(titer) |
| Part B, Group 5: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 22.1 log10(titer) |
| Part B, Group 5: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 5 log10(titer) |
| Part B, Group 5: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 76.4 log10(titer) |
| Part B, Group 5: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 log10(titer) |
| Part B, Group 6: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 16.8 log10(titer) |
| Part B, Group 6: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 67.5 log10(titer) |
| Part B, Group 6: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 log10(titer) |
| Part B, Group 6: Treatment | Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 5 log10(titer) |
Secondary
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI\* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI\*), 2) MFI\* \> 3x(Visit 2 MFI\* ), and 3) MFI \> 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI\* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank\>5000 MFI), high baseline (Baseline\>6500 MFI\*) are excluded. MFI\* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
Time frame: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination, 2 weeks after the 3rd vaccination, and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 792.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 9830.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 20013.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 17530 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 4491.62 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 14.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 222.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 9.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 488.12 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 29.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 8 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 989 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 21770.38 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 19182.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 781.62 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 47.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 16300.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 78.62 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 21533.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 2088 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 4398 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 215 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 16254.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 619.12 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 60.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 5045.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 22000 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 558.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 109.38 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 86 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 237.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 140.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 232.75 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 12200.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 63.88 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 245.12 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 191 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 104.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 300.88 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 448.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 254.12 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 13211.12 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 184 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 275 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 133 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 3490.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 1213 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 385 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1020.25 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 46.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 255.5 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 303.62 Relative fluorescence units |
| Part A, Group 1: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 18019.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 162.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 4.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 160 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 418.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 259.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 154.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 236.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 10560.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 2 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 6695.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 20.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 3303.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 178.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 42.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 346.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 229 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 20 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 10.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1378.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 10.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 6951.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 9.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 1578.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 3.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 13674.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 180.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 435.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 2 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 259.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 6428.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 11121.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 133.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 18484.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 19060.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 113.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 5787.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 309.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 7920 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 179.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 5952 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 285 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 11775.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 244.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 175 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 6.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 240.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 466 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 2.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 498.5 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 49.25 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 288.38 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 490 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 398.75 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 2: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 268.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 175.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 14802.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 546.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 40.38 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 165.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 11.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 16989.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 50.38 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 17 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 277.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 6454.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 199 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 8.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1016.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 12.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 146.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 12404.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 21.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 164.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 277.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 134.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 217.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 351.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 522.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 4.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 8.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 273.12 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 275 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 76.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 8.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 117.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 105.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 207.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 20087.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 121 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 8 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 2025.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 18339 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 423.38 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 6688.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 400.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 16.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 3.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 10530 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 11629 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 100.75 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 136.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 519.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 19112.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 506.38 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 1455 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 50.5 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 7891.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 212.62 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 2331.25 Relative fluorescence units |
| Part A, Group 3: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 8530.12 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 2305.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 135 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 65.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 72.38 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 19 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 68.62 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 22000 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 19996 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 22000 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 2861.75 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 15360.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 17901.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 4480.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 10246.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 15991.12 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 2791 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 628 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 896.88 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 927.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 1836.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 1430.38 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 1213.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 893.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 1372 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 1048.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 561 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 537.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 847.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 11340.75 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 13340.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 2612.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 212.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 339.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 233.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 4.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 108 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 76.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 8.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 46.75 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 1727.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 1896.12 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 1258.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 13.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 48.88 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 1374.25 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 2721.75 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 593.5 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 863.62 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 720 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 15431.75 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 17648.12 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 5269.75 Relative fluorescence units |
| Part B, Group 4: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 13412.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 1527.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 13.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 291 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 545 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 37.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 19032 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 884.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 21657 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 43.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 59.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 749.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 12.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 15472.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 34.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 1421.12 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 6 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 389.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 557.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 907.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 21332.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 118.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 583.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 11112.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 549.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 10265 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 74.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 61 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 488.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 286 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 538.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 361.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 1636 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 173 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 131.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 709.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 88.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 182 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 9554 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 395 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 343.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 13386.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 1482.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 19599.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 87.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 507.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 15905.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 35.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 249.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 322.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 46.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 309.25 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 96.75 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 1164 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 353 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 39.5 Relative fluorescence units |
| Part B, Group 5: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 202.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 92.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 3.63 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 499.12 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 455.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 1 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 698.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 169.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 458.62 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 624.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 19.88 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 222.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 15092.38 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 50 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 278.88 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 185.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 670.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 450 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 37.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 223.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 9672 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 281.88 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 14496.62 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 189.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 50.62 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 917.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 33.12 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 8.63 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 20110.88 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 786.88 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 330.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 1348.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 99.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1713.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 8.38 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 454.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 4.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 482.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 10714.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 477.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 31.38 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 784.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 66.88 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 6621.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 437.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 247.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 8418 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 61 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 400.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 22000 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 39.75 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 247.25 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 201.5 Relative fluorescence units |
| Part B, Group 6: Treatment | Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 278 Relative fluorescence units |
Secondary
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
Time frame: 2 weeks after the 3rd vaccination (M6.5)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 4 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 4 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 6 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 6 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 10 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 12 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 11 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 12 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 10 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 14 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 12 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 5 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 11 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 12 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 11 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 7 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 3 Participants |
| Part A, Group 2: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 9 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 10 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 13 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 4 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 14 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 10 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 9 Participants |
| Part A, Group 3: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 14 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 4 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 5 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 5 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 6 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 7 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 5 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 4 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 3 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 14 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 12 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 10 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 10 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 14 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 11 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 8 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 5 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 11 Participants |
| Part B, Group 5: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 3 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5 | 14 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-21, M6.5 | 14 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IFN-γ and/or IL-2, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-21, M6.5 | 9 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-21, M6.5 | 14 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 4 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IL-21, M6.5 | 4 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5 | 7 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 10 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 10 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | LeadSeq mRNA, IL-21, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5 | 3 Participants |
| Part B, Group 6: Treatment | Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) | Total Env, IFN-γ and/or IL-2, M6.5 | 16 Participants |
Secondary
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Time frame: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 3 Participants |
| Part A, Group 2: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 Participants |
| Part A, Group 3: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 4 Participants |
| Part A, Group 3: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 6 Participants |
| Part A, Group 3: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 3 Participants |
| Part B, Group 4: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 1 Participants |
| Part B, Group 5: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 5 Participants |
| Part B, Group 5: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 6 Participants |
| Part B, Group 5: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 8 Participants |
| Part B, Group 6: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M12 | 7 Participants |
| Part B, Group 6: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M2.5 | 4 Participants |
| Part B, Group 6: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 50, M12 | 9 Participants |
| Part B, Group 6: Treatment | Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain | BG505/T332N, 1: 80, M2.5 | 1 Participants |
Secondary
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI\* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI\*), 2) MFI\* \> 3x(Visit 2 MFI\* ), and 3) MFI \> 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI\* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank\>5000 MFI), high baseline (Baseline\>6500 MFI\*) are excluded. MFI\* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
Time frame: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination, 2 weeks after the 3rd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 17 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 15 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 17 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 4 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 14 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 11 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 15 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 4 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 13 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 11 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 15 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 7 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 14 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 3 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 5 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 1 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 5 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 15 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 2 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 16 Participants |
| Part A, Group 1: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 17 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 17 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 15 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 17 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 17 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 10 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 7 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 4 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 5 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 11 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 10 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 4 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 6 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 11 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 10 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 15 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 3 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 2 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 15 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 8 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 12 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 3 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 8 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 15 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 16 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 1 Participants |
| Part A, Group 2: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 4 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 3 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 10 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 3 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 6 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 17 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 17 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 17 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 16 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 17 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 3 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 7 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 13 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 6 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 5 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 2 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 0 Participants |
| Part A, Group 3: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 5 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 7 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 4 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 11 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 13 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 6 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 4 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 11 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 3 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 2 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 4 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 11 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 4 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 8 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 10 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 4 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 11 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 13 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 6 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 12 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 6 Participants |
| Part B, Group 4: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 1 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 17 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 17 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 2 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 14 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 13 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 17 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 12 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 10 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 17 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 1 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 6 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 13 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 4 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 11 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 9 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 11 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 3 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 4 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 8 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 13 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 12 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 5 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 7 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 9 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 8 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 12 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 2 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 17 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 17 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 15 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 5 Participants |
| Part B, Group 5: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M12 | 3 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M2.5 | 8 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M12 | 15 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M6.5 | 14 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M6.5 | 3 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M12 | 4 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M2.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M2.5 | 11 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | Link14_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M6.5 | 8 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5 | 7 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 51802_D11gp120.avi/293F, 1: 50, M2.5 | 4 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12 | 15 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5 | 15 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | TT31P.2792_D11gp120.avi/293F, 1: 50, M12 | 3 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12 | 15 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4, 1: 50, M12 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M6.5 | 12 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M2.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M6.5 | 14 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | 254008_D11gp120.avi/293F, 1: 50, M2.5 | 8 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M2.5 | 4 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M6.5 | 13 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M2.5 | 5 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M12 | 2 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | B.6240_D11gp120/293F, 1: 50, M12 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M6.5 | 10 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BJOX002_D11gp120.avi/293F, 1: 50, M2.5 | 6 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M2.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_C1-113-125_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BORI_D11gp120.avi/293F, 1: 50, M12 | 2 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M12 | 3 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_pHLsecAvi, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M6.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M12 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M2.5 | 7 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M12 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | A244 D11gp120_avi, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | scrambled_MD39_peptide-biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M6.5 | 16 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | CNE20_D11gp120.avi/293F, 1: 50, M6.5 | 14 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | gp41, 1: 50, M2.5 | 1 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MPER_peptide_biotin, 1: 50, M2.5 | 0 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39.3, 1: 50, M12 | 15 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_V3_peptide_biotin, 1: 50, M12 | 10 Participants |
| Part B, Group 6: Treatment | Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA) | BG505_MD39_HR1-562-577_biotin, 1: 50, M12 | 1 Participants |