HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults. The three individual EnvSeq-1 HIV vaccine Envs used in this study are called CH505TF gp120, CH505w53 gp120, and CH505w78 gp120. This study will take place in two parts: Part A and Part B. Participants in Part A will be randomly assigned to one of four groups. Participants in each group will receive CH505TF (admixed with GLA-SE) or placebo by intramuscular (IM) injection at Months 0, 2, 4, 8, and 12. Study researchers will evaluate participant data from Part A of the study prior to enrolling participants into Part B of the study. Researchers will also evaluate data from Part A to determine the dosing for Part B. Participants in Part B will be randomly assigned to one of four groups. Participants in each group will receive IM injections at Months 0, 2, 4, 8. GLA-SE will be admixed with all the CH505 gp120 vaccines. Part B, Group 5 will follow a sequential approach to EnvSeq-1 vaccine administration with administration of the CH505TF vaccine at Month 0, then CH505w53 at Month 2, and CH505w78 at Months 4, and 8. Part B, Group 6 participants will follow an additive approach to EnvSeq-1 administration with administration of the CH505TF vaccine at Month 0; then the CH505TF and CH505w53 vaccines at Month 2; then the CH505TF, CH505w53 and CH505w78 vaccines at Month 4; then the CH505w53 and CH505w78 vaccines at Month 8. Part B, Group 7 participants will receive CH505 M5 at Months 0, 2, 4, and 8. Part B, Group 8 participants will receive placebo injections at each time point. Additional study visits will occur through Month 18 for participants in Part A and through Month 14 for participants in Part B. Visits may include physical examinations and clinical assessments; blood, urine, and stool collection; HIV testing; risk reduction counseling; and interviews/questionnaires. Study staff will contact participants for follow-up health monitoring at Month 24 for participants in Part A and at Month 20 for participants in Part B. Part C will be an open-label study arm using the EnvSeq-1 proteins in sequential administration (CH505TF, CH505w53, and CH505w78 gp120s) at the same dose as in Part B (400 mcg) to allow for in-depth analysis of B cell precursor frequency.
Interventions
BIOLOGICALCH505TF
Administered by intramuscular (IM) injection in the thigh
BIOLOGICALCH505w53
Administered by IM injection in the thigh
BIOLOGICALCH505w78
Administered by IM injection in the thigh
BIOLOGICALCH505 M5
Administered by IM injection in the thigh
BIOLOGICALGLA-SE adjuvant
Admixed with all CH505 gp120 proteins
BIOLOGICALPlacebo
Administered by IM injection in the thigh
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria: * Age of 18 through 50 years * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * 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 * Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit * Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. * Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values: Hemogram/Complete Blood Count (CBC): * Hemoglobin greater than or equal to 11.5 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells/mm\^3 * Total lymphocyte count greater than or equal to 800 cells/mm\^3 * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000/mm\^3 Chemistry: * Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal. Virology: * Negative HIV-1 and -2 blood test: Volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). * Negative Hepatitis B surface antigen (HBsAg) * Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine: * Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range). Reproductive Status: * Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. * Reproductive status: A volunteer who was born female must: * Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, or * Any other contraceptive method approved by the HVTN 115 Protocol Safety Review Team (PSRT) * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. * Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Exclusion criteria
General: * Blood products received within 120 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia * Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 115 study * Pregnant or breastfeeding * Active duty and reserve U.S. military personnel Vaccines and Other Injections: * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 115 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 115 PSRT will determine eligibility on a case-by-case basis. * Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 115 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 115 PSRT on a case-by-case basis. * Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, Hepatitis A or B) * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System: * Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses less than 60 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.) * Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination * Autoimmune disease, current or history * Adverse events of special interest (AESIs) * Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the products administered in this protocol (representative examples are listed in the study protocol) * Immunodeficiency Clinically Significant Medical Conditions: * Untreated or incompletely treated syphilis infection * Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated injections or blood draws, * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12 | 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. |
| Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12 | 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. |
| Part A: Number of Participants With Early Study Termination Associated With an Adverse Event (AE) or Reactogenicity During the Vaccine Regime | Measured through Month 24 | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm |
| Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through the Month 12 boost | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8 | 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 Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8 | 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. |
| Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | Measured through Month 20 | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm |
| Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through the Month 8 boost | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part B Chemistry and Hematology Laboratory Measures | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations | Measured at Month 8.5 | Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. |
| Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations | Measured at Month 8.5 | Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. |
| Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4 | 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 Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4 | 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. |
| Part C: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | Measured through Month 16 | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm |
| Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through the Month 4 administration | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part C Chemistry and Hematology Laboratory Measures | Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part C Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Third (Final) Vaccination | Measured at Month 4.5 | Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5. |
| Part C Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Third (Final) Vaccination | Measured at Month 4.5 | Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5. |
| Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints. |
| Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. The reported frequencies are: The % CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells out of total B cells; the % CD4bs CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of total B cells; the % CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells out of IgG+ B cells; and the % CD4bs CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of IgG+ B cells. |
| Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120 | Measured at Month 4.5 | Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5. |
| Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Measured at Months 4.5 and 12.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Measured at Months 4.5 and 12.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | Measured at Month 4.5 | ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. Positive responses are defined as (analyte optical density (OD)) \> 3×(background OD) in wells of dilutions 1:30 and 1:90. |
| Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | Measured at Month 4.5 | ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. The area under the dilution-magnitude curve (AUC) was calculated as the average untransformed optical density (OD) over the log10 dilutions using the trapezoidal rule. |
| Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations | Measured at Month 2.5 and 8.5 | Serum HIV-1-specific immunoglobulin G (IgG) responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations | Measured at Month 2.5 and 8.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part B: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120 | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part B: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120 | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part B: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part B: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part C: Percent B Cells Expressing Candidate CH103 Precursors With Immunogenetics, Function, and Structure Similar to CH103 Lineage Antibodies | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part C: Alterations in Frequency of CH103-like Precursor B Cells Prior to CH505 TF (First) Vaccination and After the Final Vaccination | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part C: Characterization of B-cell Derived Antibodies (Binding, Neutralization and Structure Compared With the CH103 Lineage Members, Including the UCA) | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination | Measured at Month 4.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination | Measured at Month 4.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. |
| Part C: Frequencies, Specificity and Phenotype of Vaccine-induced B-cell Responses as Measured by Multiparameter Flow Cytometry After Each Vaccination Compared to Baseline | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part C: Characterization of the B-cell Derived Antibodies (Binding of CH505 TF, wk53, wk78 Proteins), Neutralization of Autologous or Mutant CH505 Viruses, and Structure | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
| Part C: Response Rate and Magnitude of CD4+ T-cell Responses as Assessed by ICS Assays 2 Weeks After the Final Vaccination | No data | No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future. |
Countries
United States
Contacts
STUDY_CHAIRMagda Sobieszczyk
Columbia University
STUDY_CHAIRJames Kobie
University of Alabama at Birmingham
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine 20 mcg CH505TF mo(0,2,4,8,12) | 12 |
| Group 2: Vaccine 100 mcg CH505TF mo(0,2,4,8,12) | 12 |
| Group 3: Vaccine 400 mcg CH505TF mo(0,2,4,8,12) | 12 |
| Group 4: Placebo Placebo for CH505TF mo(0,2,4,8,12) | 6 |
| Group 5: Vaccine 400mcg CH505TF(m0), 400mcg CH505w53( | 20 |
| Group 6: Vaccine 400mcg CH505TF(m0), 400mcg CH505TF + | 20 |
| Group 7: Vaccine 400mcg CH505 M5(m0,2,4,8) | 20 |
| Group 8: Placebo Placebo(m0,2,4,8) | 5 |
| Group 9: Vaccine 400mcg CH505TF(m0), 400mcg CH505w53( | 10 |
| Total | 117 |
Baseline characteristics
| Characteristic | Total | Group 1: Vaccine | Group 2: Vaccine | Group 3: Vaccine | Group 4: Placebo | Group 5: Vaccine | Group 6: Vaccine | Group 7: Vaccine | Group 8: Placebo | Group 9: Vaccine |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 28 years | 32 years | 31 years | 27 years | 28 years | 29 years | 28 years | 28 years | 23 years | 30 years |
| Age, Customized 18 - 20 years | 8 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Customized 21 - 30 years | 62 Participants | 4 Participants | 5 Participants | 7 Participants | 4 Participants | 12 Participants | 11 Participants | 11 Participants | 4 Participants | 4 Participants |
| Age, Customized 31 - 40 years | 33 Participants | 5 Participants | 4 Participants | 2 Participants | 0 Participants | 6 Participants | 5 Participants | 7 Participants | 1 Participants | 3 Participants |
| Age, Customized 41 - 50 years | 14 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 12 Participants | 11 Participants | 12 Participants | 6 Participants | 17 Participants | 17 Participants | 15 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 8 Participants | 8 Participants | 6 Participants | 4 Participants | 17 Participants | 16 Participants | 14 Participants | 4 Participants | 7 Participants |
| Region of Enrollment USA | 117 Participants | 12 Participants | 12 Participants | 12 Participants | 6 Participants | 20 Participants | 20 Participants | 20 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 48 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 7 Participants | 9 Participants | 8 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 69 Participants | 7 Participants | 7 Participants | 8 Participants | 3 Participants | 13 Participants | 11 Participants | 12 Participants | 3 Participants | 5 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 5 | 0 / 10 |
| other Total, other adverse events | 4 / 12 | 8 / 12 | 7 / 12 | 4 / 6 | 15 / 20 | 17 / 20 | 18 / 20 | 3 / 5 | 8 / 10 |
| serious Total, serious adverse events | 0 / 12 | 1 / 12 | 0 / 12 | 0 / 6 | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 5 | 0 / 10 |
Outcome results
Primary
Number of Part B Participants Reporting Local 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 Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 15 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 14 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 9 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 11 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 6 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 10 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 6 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 14 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 17 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 6 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 16 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 3 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 15 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 2 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 2 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 3 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 15 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 2 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 12 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 2 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 13 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 5 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 2 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 13 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 14 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 14 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 3 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 5 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 12 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 5 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 13 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 3 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 3 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 4 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 3 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 14 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 2 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 4 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 1 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 3 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 3 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 2 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 2 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 0 Participants |
Primary
Number of Part B 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 Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 12 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 12 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 7 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 12 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 19 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 8 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 7 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 17 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 6 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 11 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 8 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 7 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 14 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 4 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 6 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 19 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 15 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 17 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 8 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 9 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 9 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 20 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 5 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 9 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 8 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 7 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 11 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 3 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 4 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 6 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 5 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 6 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 11 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 7 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 18 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 12 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 9 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 6 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 14 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 5 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 20 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 12 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 6 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 2 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 15 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 4 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 4 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 5 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 4 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 3 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
Primary
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Time frame: Measured through the Month 8 boost
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Lost to Follow-Up | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Investigator reason | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Did not discontinue SPA | 17 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptoms | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Withdrawal by Subject | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptoms | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Withdrawal by Subject | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Did not discontinue SPA | 20 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Investigator reason | 0 Participants |
| Part A, Group 2: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Lost to Follow-Up | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptoms | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Withdrawal by Subject | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Investigator reason | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Lost to Follow-Up | 0 Participants |
| Part A, Group 3: Vaccine | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Did not discontinue SPA | 20 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Lost to Follow-Up | 1 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Did not discontinue SPA | 4 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Withdrawal by Subject | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Investigator reason | 0 Participants |
| Part A, Group 4: Placebo | Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptoms | 0 Participants |
Primary
Number of Part C Participants Reporting Local 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 Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 6 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 6 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 7 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
Primary
Number of Part C 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 Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 10 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 9 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 7 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 2 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 9 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
Primary
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Time frame: Measured through the Month 4 administration
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptoms | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Withdrawal by Subject | 1 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Investigator reason | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Lost to Follow-Up | 0 Participants |
| Part A, Group 1: Vaccine | Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Did not discontinue SPA | 9 Participants |
Primary
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
Population: The 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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 19 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 66 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 455 | 20.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 20 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 22 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 24.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 23.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 455 | 20 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 65 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 18 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 61.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 60 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 378 | 69 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 455 | 61.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 18.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 378 | 16 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 22 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 64.5 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 19 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 16 U/L |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 378 | 22 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 21.5 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 378 | 15 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 58.5 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 20 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 61 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 455 | 27 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 16 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 18 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 378 | 20 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 22.5 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 18 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 20.5 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 378 | 74 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 22 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 65 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 20.5 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 455 | 26 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 455 | 67 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 14 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 62.5 U/L |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 61.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 20.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 22 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 16.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 378 | 23 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 455 | 20 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 63 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 67 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 378 | 66 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 19.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 18.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 18 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 378 | 18 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 455 | 14 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 22.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 22 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 19 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 20 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 68.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 64.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 64.5 U/L |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 455 | 63 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 21 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 16.5 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 15 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 15 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 19 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 22 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 58 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 57 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 66.5 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 18 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 67 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 455 | 24 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 378 | 22 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 455 | 62 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 69 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 20 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 17 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 23 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 455 | 22.5 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 378 | 21.5 U/L |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 378 | 61.5 U/L |
Primary
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
Population: The 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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 378 | 0.00085 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 13.6 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 455 | 13.8 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.00088 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 378 | 13.8 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.00081 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000885 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.00084 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 13.8 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 14 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 13.7 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.0009 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14 g/dL |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 455 | 0.0008 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.5 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 14.25 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 378 | 0.0009 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 14.2 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 378 | 14.3 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.000935 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 13.6 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.00087 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00094 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.00102 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 455 | 0.00101 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.00089 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 14.35 g/dL |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 455 | 13.8 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 14.65 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 14.15 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.0009 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.000905 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.0009 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.00084 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 378 | 0.0009 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.6 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 14.7 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 14.9 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 378 | 14.4 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 455 | 14.5 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000905 g/dL |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 455 | 0.0009 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 378 | 0.000695 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 12.3 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 455 | 12.45 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.00081 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.00083 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 455 | 0.000675 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.00072 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.00072 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00082 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 12.7 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 11.75 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 13.75 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 378 | 12.2 g/dL |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 12.7 g/dL |
Primary
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
Population: The 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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 378 | 252 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 14 | 243 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 126 | 251 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 238 | 250 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 70 | 231 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 455 | 236 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Screening | 226.5 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 126 | 218 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 238 | 224.5 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 14 | 232.85 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 70 | 222 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Screening | 229.95 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 455 | 219 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 378 | 230 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 126 | 252.5 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Screening | 249.35 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 70 | 265.5 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 14 | 264.5 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 238 | 252.5 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 378 | 247 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 455 | 245.4 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 70 | 336 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 455 | 294 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 378 | 293.5 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 14 | 289 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Screening | 262.8 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 238 | 295.5 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000 cells per mm^3)- Day 126 | 326.5 1000 cells per mm^3 |
Primary
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 1812 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 1379.5 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 18.25 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 14.25 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 684.375 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 1142.5 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 174.625 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 89.125 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 26.25 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 1065.875 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 3116.125 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 1718.5 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 28.875 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 658.625 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 3498 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 985 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 3 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 2684.5 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 109.25 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 1594 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 75.25 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 1 relative fluorescence units |
Primary
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 15775.25 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 27266.375 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 24789.25 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 5229.75 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 11897.375 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 21460.5 relative fluorescence units |
| Part A, Group 1: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 10859.875 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 27854.25 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 17409.5 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 3169.25 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 26439.75 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 7335.75 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 24931 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 12523.25 relative fluorescence units |
| Part A, Group 2: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 10491.75 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 14748.5 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 72.5 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 15397 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 28419.25 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 26973 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 25146 relative fluorescence units |
| Part A, Group 3: Vaccine | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 22807.5 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 92.5 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 1 relative fluorescence units |
| Part A, Group 4: Placebo | Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 1 relative fluorescence units |
Primary
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
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 Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Mild | 6 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | None | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Mild | 7 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Moderate | 5 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | None | 11 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | None | 10 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | None | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Mild | 6 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | None | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | None | 10 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | None | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Moderate | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | None | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Mild | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | None | 3 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Mild | 5 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Moderate | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Mild | 7 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Moderate | 5 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | None | 9 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Mild | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | None | 9 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Moderate | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Moderate | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | None | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Mild | 7 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | None | 10 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | None | 2 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Moderate | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Moderate | 4 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | None | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Mild | 6 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Mild | 7 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Moderate | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | None | 10 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Severe | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | None | 6 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain and/or Tenderness | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Mild | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Pain | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | None | 6 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Erythema and/or Induration | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Tenderness | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime | Induration/Swelling | Severe | 0 Participants |
Primary
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
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 Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | None | 6 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Mild | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | None | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | None | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Mild | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | None | 12 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | None | 10 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | None | 12 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | None | 5 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | None | 7 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Mild | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | None | 9 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Mild | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | None | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | None | 7 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Moderate | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Mild | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | None | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | None | 10 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Moderate | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Mild | 5 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Moderate | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | None | 10 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Moderate | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | None | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Mild | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Mild | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Mild | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Mild | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Severe | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Moderate | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | None | 7 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | None | 11 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Mild | 3 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | None | 12 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Mild | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | None | 6 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Mild | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | None | 12 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Mild | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Mild | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | None | 10 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Moderate | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | None | 3 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Mild | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Moderate | 3 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | None | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | None | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Moderate | 2 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | None | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Mild | 2 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Moderate | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Mild | 4 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Moderate | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Severe | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | None | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Moderate | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Mild | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Severe | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | None | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Mild | 1 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Moderate | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | None | 4 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Moderate | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Moderate | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | Mild | 2 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Max. Systemic Symptoms | None | 3 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | Mild | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Arthralgia | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Nausea | None | 5 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Mild | 2 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | Mild | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Temperature | None | 6 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Moderate | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | Mild | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Myalgia | None | 6 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Chills | Mild | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime | Malaise and/or fatigue | Moderate | 0 Participants |
Primary
Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Time frame: Measured through Month 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
Primary
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Time frame: Measured through the Month 12 boost
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 9 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 9 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 1 Participants |
| Part A, Group 2: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 2 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 1 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 4 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Part A, Group 4: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 2 Participants |
Primary
Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 5 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 4 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 0 Participants |
Primary
Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 8 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 8 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 9 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con S gp140 CFI at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TF D7gp120d371_avi/293F/Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505TFD8N156KN160K_avi/293i Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | gp41 at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_avi/293F/Mon at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | 1086C_D7gp120.avi/293F at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120 | CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5 | 0 Participants |
Primary
Part B Chemistry and Hematology Laboratory Measures
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11
Population: T5-T8 All enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Screening | 246.5 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 14 | 1.9705 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 238 | 248 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 308 | 1.805 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 70 | 1.99 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 126 | 1.8 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 70 | 5.5 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 238 | 1.85 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 126 | 241 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 238 | 3.16 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Screening | 5.63 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 14 | 5.695 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 126 | 6 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 70 | 253 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 308 | 5.39 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Screening | 3.0445 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 308 | 229.5 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 14 | 258.5 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 14 | 3.1395 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 70 | 2.97 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 126 | 2.76 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 238 | 5.935 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 308 | 3.133 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Screening | 1.805 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 126 | 3.61 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Screening | 2.0365 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 238 | 262.5 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 308 | 1.816 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 14 | 5.95 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 14 | 1.94 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 308 | 3.663 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 126 | 6.33 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 238 | 5.75 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 70 | 1.986 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 70 | 3.09 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 238 | 1.78 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Screening | 284.5 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 126 | 2.025 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 308 | 5.95 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 70 | 5.7 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 126 | 286.5 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 14 | 269 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 14 | 3.375 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 238 | 3.2765 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Screening | 3.718 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Screening | 6.15 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 308 | 282 1000 cells per mm^3 |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 70 | 272 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 14 | 3.44 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 70 | 6 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 126 | 6.67 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 70 | 3.49 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Screening | 6.12 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 14 | 6.1 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 238 | 5.98 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 308 | 5.6 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Screening | 3.805 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 126 | 3.7 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 238 | 3.245 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 308 | 3.416 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Screening | 1.8095 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 14 | 1.89 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 70 | 1.76 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 126 | 1.99 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 238 | 1.885 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 308 | 1.72 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Screening | 274 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 14 | 274 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 70 | 277.3 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 126 | 265 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 238 | 272.3 1000 cells per mm^3 |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 308 | 274.9 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 308 | 4.225 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 238 | 3.0805 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 308 | 262.9 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Screening | 269 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Screening | 4.361 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 308 | 7.33 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 238 | 242.3 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 14 | 281 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 238 | 5.615 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Screening | 6.9 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 126 | 5.49 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 70 | 229.05 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 126 | 3.3835 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 70 | 2.9985 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 70 | 5.13 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 126 | 244.85 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 126 | 1.553 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 70 | 1.619 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 14 | 3.029 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 238 | 1.836 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 14 | 1.72 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Screening | 1.918 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 14 | 5.27 1000 cells per mm^3 |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 308 | 2.0175 1000 cells per mm^3 |
Primary
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11
Population: T5-T8 All enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 308 | 60 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 59 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 13 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 308 | 17 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 308 | 14.5 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 57.5 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 14 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 18 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 63 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 18 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 16 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 14.5 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 19 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 18 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 65 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 53.5 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 20 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 58 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 61 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 20.5 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 23.5 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 308 | 59 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 308 | 21 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 18.5 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 18.5 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 60.5 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 18 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 19 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 18 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 62 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 18.5 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 308 | 20 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 22 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 60 U/L |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 21 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 17 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 18 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 308 | 60 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 16.5 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 15 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 17 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 14.5 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 308 | 19 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 18 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 18 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 19 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 18 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 308 | 18 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 64 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 62 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 63 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 64 U/L |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 67.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 79 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 18 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 308 | 14.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 238 | 15 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 76 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 22 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 18.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 308 | 66.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 60.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 15 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 238 | 59 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 238 | 16.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 64 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 308 | 18 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 18.5 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 19 U/L |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 20 U/L |
Primary
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11
Population: T5-T8 All enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00086 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.00089 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.00093 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.0009 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.0009 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 308 | 0.0009 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 308 | 13.45 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 13.55 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 13.7 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 13.7 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 13.9 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 14 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 13.9 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.000875 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 14.45 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 14.1 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00088 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 14.05 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 308 | 14.55 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 308 | 0.00082 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.0009 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.000895 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.000885 g/dL |
| Part A, Group 2: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.65 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 14 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.35 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 13.4 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 13.8 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 308 | 14.1 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.00093 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.00087 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 13.9 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00087 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.00085 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.0009 g/dL |
| Part A, Group 3: Vaccine | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 308 | 0.0009 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 13.65 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.2 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.00095 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 308 | 0.00087 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.000765 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.000765 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 238 | 13.8 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 238 | 0.00082 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 308 | 14.1 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 13.8 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00081 g/dL |
| Part A, Group 4: Placebo | Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 13.75 g/dL |
Primary
Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Time frame: Measured at Month 8.5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A, Group 1: Vaccine | Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations | 1.1384246921 log10 titer*percentage of isolates |
| Part A, Group 2: Vaccine | Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations | 1.1849438379 log10 titer*percentage of isolates |
| Part A, Group 3: Vaccine | Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations | 1.1194766117 log10 titer*percentage of isolates |
| Part A, Group 4: Placebo | Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations | 0.6989700043 log10 titer*percentage of isolates |
Primary
Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Time frame: Measured at Month 8.5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A, Group 1: Vaccine | Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations | 0.6989700043 log10 titer*percentage of isolates |
| Part A, Group 2: Vaccine | Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations | 0.7500872649 log10 titer*percentage of isolates |
| Part A, Group 3: Vaccine | Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations | 0.6989700043 log10 titer*percentage of isolates |
| Part A, Group 4: Placebo | Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations | 0.6989700043 log10 titer*percentage of isolates |
Primary
Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Time frame: Measured through Month 20
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
| Part A, Group 2: Vaccine | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
| Part A, Group 3: Vaccine | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
| Part A, Group 4: Placebo | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
Primary
Part C Chemistry and Hematology Laboratory Measures
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10
Population: T9 All enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Screening | 5.95 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 14 | 6.08 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 70 | 6.67 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 126 | 6.2 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | WBC (1000 cells per mm^3)- Day 303 | 7.62 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Screening | 3.783 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 14 | 3.47 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 70 | 3.5 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 126 | 3.639 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells per mm^3)- Day 303 | 4.58 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Screening | 1.6835 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 14 | 1.629 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 70 | 1.73 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 126 | 1.562 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells per mm^3)- Day 303 | 1.806 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Screening | 276.5 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 14 | 299 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 70 | 288 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 126 | 275 1000 cells per mm^3 |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures | Platelets (1000 cells per mm^3)- Day 303 | 280 1000 cells per mm^3 |
Primary
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10
Population: T9 All enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 13 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 14 | 13 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 70 | 14 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 126 | 13 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day 303 | 14 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 17.5 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 14 | 16 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 70 | 16 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 126 | 14 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day 303 | 16 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 73.5 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 14 | 60 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 70 | 63 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 126 | 61 U/L |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day 303 | 63 U/L |
Primary
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10
Population: T9 All enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.45 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 14 | 13.85 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 70 | 14.3 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 126 | 13.9 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day 303 | 13.6 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000815 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 14 | 0.00082 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 70 | 0.0008 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 126 | 0.00083 g/dL |
| Part A, Group 1: Vaccine | Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day 303 | 0.00084 g/dL |
Primary
Part C: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Time frame: Measured through Month 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Part C: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime | 0 Participants |
Secondary
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Months 4.5 and 12.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 4.5 and 12.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 0.07193596 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 0.07052576 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 0.04602687 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 0.04420066 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 0.02507079 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 0.0213444 % CD4+ T-cells |
| Part A, Group 2: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 0.02479532 % CD4+ T-cells |
| Part A, Group 2: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 0.02299821 % CD4+ T-cells |
| Part A, Group 2: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 0.132646355 % CD4+ T-cells |
| Part A, Group 2: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 0.0783176 % CD4+ T-cells |
| Part A, Group 2: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 0.04367241 % CD4+ T-cells |
| Part A, Group 2: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 0.048858555 % CD4+ T-cells |
| Part A, Group 3: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 0.04605537 % CD4+ T-cells |
| Part A, Group 3: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 0.04050064 % CD4+ T-cells |
| Part A, Group 3: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 0.02889892 % CD4+ T-cells |
| Part A, Group 3: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 0.02428899 % CD4+ T-cells |
| Part A, Group 3: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 0.021711805 % CD4+ T-cells |
| Part A, Group 3: Vaccine | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 0.073603225 % CD4+ T-cells |
| Part A, Group 4: Placebo | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 0.00128743 % CD4+ T-cells |
| Part A, Group 4: Placebo | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | -0.00849484 % CD4+ T-cells |
| Part A, Group 4: Placebo | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | -0.00279413 % CD4+ T-cells |
| Part A, Group 4: Placebo | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 0.00867745 % CD4+ T-cells |
| Part A, Group 4: Placebo | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 0.00911761 % CD4+ T-cells |
| Part A, Group 4: Placebo | Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | -0.00285989 % CD4+ T-cells |
Secondary
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. The reported frequencies are: The % CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells out of total B cells; the % CD4bs CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of total B cells; the % CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells out of IgG+ B cells; and the % CD4bs CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of IgG+ B cells.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 0.0336336336 % B-cells |
| Part A, Group 1: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 0.3432494279 % B-cells |
| Part A, Group 1: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 0.3928819444 % B-cells |
| Part A, Group 1: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 3.9065053939 % B-cells |
| Part A, Group 2: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 0.2227163176 % B-cells |
| Part A, Group 2: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 0.5019394658 % B-cells |
| Part A, Group 2: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 3.4168305845 % B-cells |
| Part A, Group 2: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 0.0383802953 % B-cells |
| Part A, Group 3: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 0.6492676935 % B-cells |
| Part A, Group 3: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 0.2295544376 % B-cells |
| Part A, Group 3: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 4.0027261874 % B-cells |
| Part A, Group 3: Vaccine | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 0.033951166 % B-cells |
| Part A, Group 4: Placebo | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 0.0051081002 % B-cells |
| Part A, Group 4: Placebo | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 0.001277025 % B-cells |
| Part A, Group 4: Placebo | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 0.0052190432 % B-cells |
| Part A, Group 4: Placebo | Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 0.0062628519 % B-cells |
Secondary
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. The area under the dilution-magnitude curve (AUC) was calculated as the average untransformed optical density (OD) over the log10 dilutions using the trapezoidal rule.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 6.6971124919 Optical density |
| Part A, Group 1: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 5.6756913098 Optical density |
| Part A, Group 1: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 6.1512380643 Optical density |
| Part A, Group 2: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 6.8592025102 Optical density |
| Part A, Group 2: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 6.1353499266 Optical density |
| Part A, Group 2: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 6.5292373784 Optical density |
| Part A, Group 3: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 7.3797656551 Optical density |
| Part A, Group 3: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 7.5422612265 Optical density |
| Part A, Group 3: Vaccine | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 6.7855111323 Optical density |
| Part A, Group 4: Placebo | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 0.229304475 Optical density |
| Part A, Group 4: Placebo | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 0.2366759984 Optical density |
| Part A, Group 4: Placebo | Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 0.2318809298 Optical density |
Secondary
Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Time frame: Measured at Month 4.5
Population: Only participants with data available for all six isolates are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part A, Group 1: Vaccine | Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120 | 0.94 log10 titer*percentage of isolates |
| Part A, Group 2: Vaccine | Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120 | 0.93 log10 titer*percentage of isolates |
| Part A, Group 3: Vaccine | Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120 | 0.97 log10 titer*percentage of isolates |
| Part A, Group 4: Placebo | Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120 | 0.70 log10 titer*percentage of isolates |
Secondary
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 11 Participants |
| Part A, Group 1: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 10 Participants |
| Part A, Group 1: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 11 Participants |
| Part A, Group 1: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 9 Participants |
| Part A, Group 2: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 9 Participants |
| Part A, Group 2: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 11 Participants |
| Part A, Group 2: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 11 Participants |
| Part A, Group 2: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 9 Participants |
| Part A, Group 3: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 12 Participants |
| Part A, Group 3: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 12 Participants |
| Part A, Group 4: Placebo | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ B cells | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ B cells | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CH505+ IgG+ B cells | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120 | CD4bs+ CH505+ IgG+ B cells | 0 Participants |
Secondary
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Months 4.5 and 12.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 4.5 and 12.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 4 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 2 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 0 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 5 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 3 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 12.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Any Env at Month 12.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 4.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-1-PTEg-SEQ at Month 12.5 | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF | Env-2-PTEg-SEQ at Month 4.5 | 0 Participants |
Secondary
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. Positive responses are defined as (analyte OD) \> 3×(background OD) in wells of dilutions 1:30 and 1:90.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 11 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 11 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 11 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 11 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 11 Participants |
| Part A, Group 2: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 11 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 12 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 12 Participants |
| Part A, Group 3: Vaccine | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 12 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7 gp120_avi/293F/Mon | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH505TF_D7gp120d371_avi | 0 Participants |
| Part A, Group 4: Placebo | Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding | CH0505_CON D7gp120_D368R_avi/293F/Mon | 0 Participants |
Secondary
Part B: HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Time frame: Measured at Month 2.5 and Month 8.5
Secondary
Part B: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Months 2.5 and 8.5
Secondary
Part B: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. The area under the dilution-magnitude curve (AUC) was calculated as the average untransformed optical density (OD) over the log10 dilutions using the trapezoidal rule.
Time frame: Measured at Month 2.5
Secondary
Part B: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Months 2.5 and 8.5
Secondary
Part B: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. Positive responses are defined as (analyte OD) \> 3×(background OD) in wells of dilutions 1:30 and 1:90.
Time frame: Measured at Month 2.5
Secondary
Part C: Alterations in Frequency of CH103-like Precursor B Cells Prior to CH505 TF (First) Vaccination and After the Final Vaccination
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Time frame: Measured at Month 0 and at Month 4.5
Secondary
Part C: Characterization of B-cell Derived Antibodies (Binding, Neutralization and Structure Compared With the CH103 Lineage Members, Including the UCA)
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Time frame: Measured at Month 4.5
Secondary
Part C: Characterization of the B-cell Derived Antibodies (Binding of CH505 TF, wk53, wk78 Proteins), Neutralization of Autologous or Mutant CH505 Viruses, and Structure
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Time frame: Measured at Month 0, Month 2.5 and Month 4.5
Secondary
Part C: Frequencies, Specificity and Phenotype of Vaccine-induced B-cell Responses as Measured by Multiparameter Flow Cytometry After Each Vaccination Compared to Baseline
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Time frame: Measured at Month 0, Month 2.5 and Month 4.5
Secondary
Part C: HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Time frame: Measured at Month 4.5
Secondary
Part C Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Third (Final) Vaccination
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Time frame: Measured at Month 4.5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A, Group 1: Vaccine | Part C Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Third (Final) Vaccination | 0.9919921716 log10 titer*percentage of isolates |
Secondary
Part C Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Third (Final) Vaccination
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Time frame: Measured at Month 4.5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A, Group 1: Vaccine | Part C Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Third (Final) Vaccination | 0.8284675826 log10 titer*percentage of isolates |
Secondary
Part C: Percent B Cells Expressing Candidate CH103 Precursors With Immunogenetics, Function, and Structure Similar to CH103 Lineage Antibodies
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Time frame: Measured at Month 4.5
Secondary
Part C: Response Rate and Magnitude of CD4+ T-cell Responses as Assessed by ICS Assays 2 Weeks After the Final Vaccination
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Month 4.5