HIV Infections
Conditions
Brief summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity of CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from transiently transfected cells in healthy, HIV-1-uninfected adult participants.
Detailed description
This study will compare the safety, tolerability, and immunogenicity of two experimental HIV vaccines in healthy, HIV-1-uninfected adult participants. The study vaccines are called Stable CH505TF gp120 and Transient CH505TF gp120. The vaccines are mixed with an adjuvant called GLA-SE. Participants will be randomly assigned to two groups. Participants in Group 1 will receive Stable CH505TF gp120; participants in Group 2 will receive Transient CH505TF. Depending on their group, participants will receive Stable CH505TF gp120 or Transient CH505TF gp120 by injection at Months 0, 2, and 6. Additional study visits will occur at Months 0.5, 2.5, 6.5, 9, and 12. Study visits may include physical examinations, medical history, vaccine injections, blood and urine collection, risk reduction counseling, and questionnaires. Participants will also be contacted for health information at Month 18.
Interventions
BIOLOGICALStable CH505TF gp120
Administered by IM injection in the deltoid of the non-dominant arm
BIOLOGICALTransient CH505TF gp120
Administered by IM injection in the deltoid of the non-dominant arm
BIOLOGICALGlucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE)
Admixed with Stable CH505TF gp120 or Transient CH505TF gp120 for IM injection in the deltoid of the non-dominant arm
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria * Age of 18 to 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 * Willing to be contacted in person or by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits * Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit * 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. (see study protocol) Laboratory Inclusion Values Hemogram/Complete blood count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth). * 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: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). * 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 assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-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 assigned female sex at birth must: * Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until 3 months after the final study vaccination. 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 123 Protocol Safety Review Team (PSRT) * Successful vasectomy in any partner assigned male sex at birth (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 post vasectomy); * 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 assigned female sex at birth 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 123 study * Pregnant or breastfeeding * Active duty and reserve US 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 123 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 123 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 by the HVTN 123 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 123 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 123 PSRT on a case-by-case basis. * Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, 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 or equal to 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment) * Serious adverse reactions to vaccines 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 * Immunodeficiency Clinically significant medical conditions * 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 |
|---|---|---|
| Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | Measured at Month 6.5 | Samples were titrated for IgG to CH505TF gp120 (transient transfection) and CH505TF gp120 (stable transfection) at month 0 (Visit 2) and month 6.5 (Visit 7), with a starting 1:50 dilution followed by a 5-fold dilution series, ending at 1:156250 dilution. The AUC value was calculated using the trapezoidal rule based on the raw MFI values truncated at zero across the log base 10 dilution series. For each combination of individual and antigen, AUC at each time point was the sum of the areas of the trapezoids calculated between any non-excluded data points in the analyte/titration. AUC was not calculated for any samples which were incompletely titrated, or where a dilution was missing due to failing QC criteria. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
| Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | Measured at Month 6.5 | Serum HIV-1 specific IgG responses were measured on a BioPlex instrument using a standardized custom HIV1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI). Samples were titrated for IgG to CH505TF gp120 (transient transfection) and CH505TF gp120 (stable transfection) at month 0 (Visit 2) and month 6.5 (Visit 7), with a starting 1:50 dilution followed by a 5-fold dilution series. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) the net MFI (MFI minus Blank) values were ≥ antigen-specific cutoff at the 1:50 dilution level for IgG, (2) the net MFI values were greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values were greater than 3 times the baseline MFI values. |
| Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI) | Measured at Month 6.5 | Serum HIV-1 specific IgG responses were measured on a BioPlex instrument using a standardized custom HIV1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) the net MFI (MFI minus Blank) values were ≥ antigen-specific cutoff at the 1:50 dilution level for IgG, (2) the net MFI values were greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values were greater than 3 times the baseline MFI values. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 7 days after each vaccine dose | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 7 days after each vaccine dose | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 7 days after each vaccine dose | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Measured during screening, Days 14, 70, 182, 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Measured during screening, Days 14, 70, 182, 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Measured during screening, Days 14, 70, 182, 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Measured during screening, Days 14, 70, 182, 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Measured during screening, Days 14, 70, 182, 273 | The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm |
| Adverse Events of Special Interest (AESIs) | Adverse Events of Special Interest (AESI) health contact is at month 18 | AEs of special interest (AESI) for this protocol include but are not limited to potential immune-mediated diseases. AESI are reported regardless of relationship to study product(s). All AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | Measured at Months 2.5 and 6.5 | Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tatregulated luciferase (Luc) reporter gene expression in TZMbl cells. Response magnitudes were assessed using neutralization titer, which is defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Higher neutralization titer indicates higher response level. Response to a virus/isolate was considered positive if the neutralization titer was above 10. Data are excluded if blood draw date was outside the allowable window, assay results are deemed unreliable for analysis by the lab, or a participant was HIV-infected. |
| Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | Measured at Months 2.5 and 6.5 | Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tatregulated luciferase (Luc) reporter gene expression in TZMbl cells. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The prespecified cutoff for ID50 and ID80 was 10. Data are excluded if blood draw date was outside the allowable window, assay results are deemed unreliable for analysis by the lab, or a participant was HIV-infected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine 100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6 | 15 |
| Group 2: Vaccine 100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6 | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: Vaccine | Group 2: Vaccine | Total |
|---|---|---|---|
| Age, Continuous | 28 years | 28 years | 28 years |
| Age, Customized 18 - 20 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized 21 - 30 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Customized 31 - 40 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized 41 - 50 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 13 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment United States | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 7 / 15 | 7 / 15 |
| serious Total, serious adverse events | 1 / 15 | 0 / 15 |
Outcome results
Primary
Adverse Events of Special Interest (AESIs)
AEs of special interest (AESI) for this protocol include but are not limited to potential immune-mediated diseases. AESI are reported regardless of relationship to study product(s). All AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
Time frame: Adverse Events of Special Interest (AESI) health contact is at month 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Adverse Events of Special Interest (AESIs) | N | 15 Participants |
| Group 1: Vaccine | Adverse Events of Special Interest (AESIs) | Y | 0 Participants |
| Group 2: Vaccine | Adverse Events of Special Interest (AESIs) | Y | 1 Participants |
| Group 2: Vaccine | Adverse Events of Special Interest (AESIs) | N | 14 Participants |
Primary
Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins
Samples were titrated for IgG to CH505TF gp120 (transient transfection) and CH505TF gp120 (stable transfection) at month 0 (Visit 2) and month 6.5 (Visit 7), with a starting 1:50 dilution followed by a 5-fold dilution series, ending at 1:156250 dilution. The AUC value was calculated using the trapezoidal rule based on the raw MFI values truncated at zero across the log base 10 dilution series. For each combination of individual and antigen, AUC at each time point was the sum of the areas of the trapezoids calculated between any non-excluded data points in the analyte/titration. AUC was not calculated for any samples which were incompletely titrated, or where a dilution was missing due to failing QC criteria. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the number of participants with positive total IgG Binding Antibody responses at Month 6.5.~Number Analyzed shows the number of participants with positive total IgG Binding Antibody responses after filtering for assay specific quality control criteria at Month 6.5.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Transient | 23190.6 MFI*log10(1/dilution) |
| Group 1: Vaccine | Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Stable | 21550.9 MFI*log10(1/dilution) |
| Group 2: Vaccine | Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Stable | 34973.9 MFI*log10(1/dilution) |
| Group 2: Vaccine | Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Transient | 36942.1 MFI*log10(1/dilution) |
Primary
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182, 273
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 182 | 17 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 70 | 18 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Baseline | 22 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 182 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 273 | 17 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 273 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 70 | 18.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Baseline | 61 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Baseline | 25 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 70 | 64 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 14 | 20 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 182 | 61 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 14 | 18 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 273 | 63 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 14 | 58 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 273 | 60 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 14 | 60 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Baseline | 19 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 14 | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 70 | 18 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 182 | 18.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alanine Aminotransferase -Day 273 | 19 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Baseline | 19 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 14 | 18 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 70 | 21 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 182 | 21.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Aspartate Aminotransferase -Day 273 | 24 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Baseline | 60 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 70 | 61 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L | Alkaline Phosphatase -Day 182 | 64 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182, 273
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 14 | 0.89 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 182 | 0.88 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 70 | 0.87 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 273 | 0.91 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Baseline | 0.91 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 273 | 0.85 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Baseline | 0.79 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 14 | 0.88 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 70 | 0.84 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine -Day 182 | 0.82 mg/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182, 273
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 14 | 13 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Baseline | 14 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 70 | 14 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 273 | 15 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 182 | 14 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 273 | 14 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 182 | 14 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Baseline | 14 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 14 | 13 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin -Day 70 | 14 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182, 273
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 70 | 6.4 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Baseline | 2.128 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Baseline | 238 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 14 | 1.84 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 14 | 6.3 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 70 | 1.981 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 14 | 257 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 182 | 2.06 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 182 | 6.8 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 273 | 2.07 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 70 | 238 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Baseline | 3.74 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Baseline | 6.3 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 14 | 3.631 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 182 | 243 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 70 | 3.503 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 273 | 6.2 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 273 | 238 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 273 | 3.329 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 182 | 3.623 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 273 | 3.6 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Baseline | 6.6 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 14 | 6.2 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 70 | 6.3 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 182 | 6.4 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | WBC -Day 273 | 6.3 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Baseline | 268 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 14 | 267 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 70 | 262 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 182 | 267.5 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Platelets -Day 273 | 265 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Baseline | 2.2 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 14 | 1.98 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 70 | 1.91 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 182 | 1.874 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Lymphocytes -Day 273 | 1.729 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Baseline | 3.713 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 14 | 3.93 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 70 | 3.437 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm | Neutrophils -Day 182 | 3.582 1000 cells/cubic mm |
Primary
Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI)
Serum HIV-1 specific IgG responses were measured on a BioPlex instrument using a standardized custom HIV1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) the net MFI (MFI minus Blank) values were ≥ antigen-specific cutoff at the 1:50 dilution level for IgG, (2) the net MFI values were greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values were greater than 3 times the baseline MFI values.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the number of participants with positive total IgG Binding Antibody responses at Month 6.5.~Number Analyzed shows the number of participants with positive total IgG Binding Antibody responses after filtering for assay specific quality control criteria at Month 6.5.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI) | CH505TF gp120 Stable | 22000 Net mean fluorescent intensity (net MFI) |
| Group 1: Vaccine | Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI) | CH505TF gp120 Transient | 22000 Net mean fluorescent intensity (net MFI) |
| Group 2: Vaccine | Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI) | CH505TF gp120 Stable | 22000 Net mean fluorescent intensity (net MFI) |
| Group 2: Vaccine | Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI) | CH505TF gp120 Transient | 22000 Net mean fluorescent intensity (net MFI) |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after each vaccine dose
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 to less than 10 cm dim. | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 12 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 12 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 to less than 10 cm dim. | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10 cm dim. | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 to less than 10 cm dim. | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10 cm dim. | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after each vaccine dose
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after each vaccine dose
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 12 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 9 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
Primary
Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins
Serum HIV-1 specific IgG responses were measured on a BioPlex instrument using a standardized custom HIV1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI). Samples were titrated for IgG to CH505TF gp120 (transient transfection) and CH505TF gp120 (stable transfection) at month 0 (Visit 2) and month 6.5 (Visit 7), with a starting 1:50 dilution followed by a 5-fold dilution series. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) the net MFI (MFI minus Blank) values were ≥ antigen-specific cutoff at the 1:50 dilution level for IgG, (2) the net MFI values were greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values were greater than 3 times the baseline MFI values.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with available BAMA data at Month 6.5.~Number Analyzed shows the number of positive responders with available BAMA data after filtering for assay specific quality control criteria at Month 6.5.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Stable | 12 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Transient | 12 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Stable | 13 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins | CH505TF gp120 Transient | 13 Participants |
Primary
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm
Time frame: Measured during screening, Days 14, 70, 182, 273
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Creatinine (mg/dL)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Aspartate Aminotransferase (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Alkaline Phosphatase (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Baseline | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 2: Vaccine | The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
Secondary
Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tatregulated luciferase (Luc) reporter gene expression in TZMbl cells. Response magnitudes were assessed using neutralization titer, which is defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Higher neutralization titer indicates higher response level. Response to a virus/isolate was considered positive if the neutralization titer was above 10. Data are excluded if blood draw date was outside the allowable window, assay results are deemed unreliable for analysis by the lab, or a participant was HIV-infected.
Time frame: Measured at Months 2.5 and 6.5
Population: Overall number of participants analyzed represents the number of participants with positive nAB responses at Months 2.5 and/or 6.5.~Number Analyzed shows the number of participants with positive nAB responses after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID50), V5, M6.5 | 492.5 1/dilution |
| Group 1: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V7, M6.5 | 173.2 1/dilution |
| Group 1: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID50), V5, M2.5 | 135.7 1/dilution |
| Group 1: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V7, M2.5 | 32.9 1/dilution |
| Group 2: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V7, M6.5 | 135.7 1/dilution |
| Group 2: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID50), V5, M6.5 | 11.6 1/dilution |
| Group 2: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID50), V5, M2.5 | 122.9 1/dilution |
| Group 2: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID50), V5, M6.5 | 404.1 1/dilution |
| Group 2: Vaccine | Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V7, M2.5 | 39.4 1/dilution |
Secondary
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tatregulated luciferase (Luc) reporter gene expression in TZMbl cells. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The prespecified cutoff for ID50 and ID80 was 10. Data are excluded if blood draw date was outside the allowable window, assay results are deemed unreliable for analysis by the lab, or a participant was HIV-infected.
Time frame: Measured at Months 2.5 and 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with available nAB data at Months 2.5 and/or 6.5.~Number Analyzed shows the number of HIV uninfected participants with available nAB data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID50), V5, M2.5 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer, (ID50), V5, M2.5 | 11 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID50), V7, M6.5 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V5, M2.5 | 10 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID80), V5, M2.5 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID50), V7, M6.5 | 12 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID80), V7, M6.5 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V7, M6.5 | 11 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID80), V7, M6.5 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V7, M6.5 | 13 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID50), V7, M6.5 | 14 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer (ID80), V5, M2.5 | 12 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID50), V5, M2.5 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID50), V7, M6.5 | 2 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505TF, Titer (ID80), V5, M2.5 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods | CH505.w4.3, Titer, (ID50), V5, M2.5 | 13 Participants |