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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study evaluated the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.
This study evaluated evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.
This study enrolled 38 mother-infant pairs. To quantify the maternal HIV antibody response, mothers were also enrolled in the study but not received study product. Infants received the CH505TF gp120 protein adjuvanted with GLA-SE at Weeks 0, 8, 16, 32, and 54. The first dose was given within the first five days of life.
The study was conducted in three parts (Parts A, B, and C), and to ensure safety, enrollment proceeded in stages.
Part A (Initial Safety) enrolled first. 5 infants in Part A received a low dose of protein with a low dose of adjuvant and 2 infants received placebo.
After safety review post first vaccination of infants in Part A, Part B enrolled. In Part B (Safety Ramp-Up), 2 infants received a higher dose of protein with a higher dose of adjuvant and 2 infants received placebo.
After safety review post first vaccination of infants in Part B, Part C enrolled. In Part C (Immunogenicity), 5 infants received low dose protein with higher dose of adjuvant, 16 infants received a higher dose of protein with higher dose of adjuvant, and 6 infants received placebo.
There were 14 scheduled clinic visits over 24.5 months. For infants, study visits included some or all of the following: physical examinations, medical history, vaccine injections, HIV testing, and blood, cord blood, and stool collection. For mothers, study visits included some or all of the following: medical history, physical examinations, questionnaires, risk reduction counseling, and blood, breastmilk, and stool collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Group 1: CH505TF gp120 + GLA-SE | Experimental | Participants received 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL intramuscular (IM) injection into either thigh at Weeks 0, 8, 16, 32, and 54. |
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| Part A, Group 2: Placebo | Placebo Comparator | Participants received Placebo administered as a 0.25 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54. |
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| Part B, Group 3: CH505TF gp120 + GLA-SE | Experimental | Participants received 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54. |
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| Part B, Group 4: Placebo | Placebo Comparator | Participants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54. |
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| Part C, Group 5: CH505TF gp120 + GLA-SE | Experimental | Participants received 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CH505TF gp120 | Biological | HIV-1 CH505 transmitted/founder virus Env gp120 immunogen |
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| Measure | Description | Time Frame |
|---|---|---|
| WHO Anthropometric Measure of Weight-for-Age Z-Score | At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score will be calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. This Outcome Measure was not collected for Mothers. | Measured at each study visit. |
| Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. Z-scores less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. | Measured at each study visit. |
| WHO Anthropometric Measure of Weight-for-Length Z-Score | At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. This Outcome Measure was not collected for Mothers. | Measured at each study visit. |
| Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories |
| Measure | Description | Time Frame |
|---|---|---|
| EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus) | PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against diphtheria, tetanus, pertussis, and rubella. The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. A Hepatitis B antigen was tested as part of the PVMA panel, but did not pass lab-internal QC. The lab opted to test this antigen via ELISA and reported those calculated concentration data for analysis in lieu of the HepB PVMA data. A HepB standard was used in each assay for quality control. |
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Infant Inclusion Criteria:
Infant Exclusion Criteria:
Mother Inclusion Criteria:
Mother Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avy Violari | Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital | Study Chair |
| Georgia Tomaras | Duke University, HVTN Laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perinatal HIV Research Unit (PHRU), Soweto CRS | Johannesburg | Gauteng | 1862 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40178906 | Derived | Violari A, Otwombe K, Hahn W, Chen S, Josipovic D, Baba V, Angelidou A, Smolen KK, Levy O, Mkhize NN, Woodward Davis AS, Martin TM, Haynes BF, Williams WB, Sagawa ZK, Kublin JG, Polakowski L, Brewinski Isaacs M, Yen C, Tomaras G, Corey L, Janes H, Gray GE. Safety and implementation of phase I randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns. J Clin Invest. 2025 Apr 3;135(11):e186927. doi: 10.1172/JCI186927. eCollection 2025 Jun 2. | |
| 39484284 |
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This study enrolled 38 mother-infant pairs. Mothers were also enrolled to assess maternal HIV antibody response but did not receive study product. All mother-infant pairs were assigned to Groups as a unit. The values reported reflect the number of infants, who were the primary participants. Each infant corresponds to one unique mother, so the number of mothers equals the number of infants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54 |
| FG001 | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2020 | May 20, 2025 |
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| Part C, Group 6: Placebo | Placebo Comparator | Participants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54. |
|
| Part C, Group 7: CH505TF gp120 + GLA-SE | Experimental | Participants received 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54. |
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| Part C, Group 8: Placebo | Placebo Comparator | Participants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54. |
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| GLA-SE adjuvant | Biological | An oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA) |
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| Placebo | Biological | Sodium Chloride for Injection, 0.9% USP |
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At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. Z-scores less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. |
| Measured at each study visit. |
| 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. This Outcome Measure was not collected for Mothers. | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). |
| 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. This Outcome Measure was not collected for Mothers. | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). |
| 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: fever, sleepiness/lethargy, rash, vomiting, anorexia, seizure. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities for a participant. This Outcome Measure was not collected for Mothers. | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). |
| Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point. This Outcome Measure was not collected for Mothers. | ALT, creatinine, hemoglobin, platelets, and WBC measured at Screening (Day 0) and Days 14, 70, 126, 238, 393, 743; Lymphocytes and Neutrophils measured at Days 14, 70, 126, 238, 393, 743. |
| Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). This Outcome Measure was not collected for Mothers. | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). This Outcome Measure was not collected for Mothers. | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). This Outcome Measure was not collected for Mothers. | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. |
| Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination | Serum HIV-1-specific IgG responses were measured on a BioPlex instrument (BioRad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Net MFI less than 1 is set to 1, and net MFI > 22,000 is set to 22,000. The area under the curve (AUC) was calculated for each participant and antigen using the trapezoidal rule, where the x-axis is log10 dilution and the y-axis is the Net MFI with negative values set to 0. AUC is considered the primary measure of response magnitude. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination | HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+. | Measured at month 4.5 (2 weeks post the 3rd vaccination). |
| Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations | HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+. | Measured at month 13 (2 weeks after the 5th vaccination). |
| Measured at month 13, 2 weeks after the 5th vaccination. |
| EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (HiB and RSV) | PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against Haemophilus influenzae type B (HiB) and respiratory syncytial virus (RSV). The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination. | Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. All serum samples were assayed against Tier 1 and Tier 2 strains of virus by starting with a 1:10 dilution of serum to obtain a neutralizing antibody titer. ID50 (ID80) titers are defined as the serum dilution that reduces RLUs by 50% (or 80%) relative to the RLUs in virus control wells after subtraction of background. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination | Serum HIV-1-specific FcR responses (1:50 dilution) were measured using the standardized custom HIV-1 Luminex assay on a Luminex FLEXMAP 3D system. Readouts were background-subtracted mean fluorescence intensity (MFI), with background defined by plate-level controls. Net MFI was calculated as experimental minus reference antigen MFI, and values <1 were set to 1. Post-enrollment samples were considered positive if they met all three criteria: (1) Net MFI ≥ antigen-specific cutoff (95th percentile of HVTN 115 Part A baseline at Day 0) and ≥ 100 above blank; (2) Net MFI > 3 times the median baseline Net MFI; and (3) MFI > 3 times the median baseline MFI. Response calls were based on the 1:50 dilution. Data were excluded if the blood draw was outside the allowable window, the participant was HIV positive, reference antigen MFI > 5,000, or baseline net MFI > 6,500. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination | Serum HIV-1-specific FcR (dilution 1:50) responses were measured on a Luminex FLEXMAP 3D Instrument System using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. 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. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination | The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to %GzB activity. A positive response is defined as ≥ 8% GzB activity. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination | The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination | ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 * (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to percent killing or loss of luciferase activity. A positive response is defined as percent specific killing ≥ 15%. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination | ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 * (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). | Measured at month 13, 2 weeks after the 5th vaccination. |
| Response Rate of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. Positivity calls were based on two criteria: 1) Average ADCP score ≥ antigen specific cutoff values (max(95th percentile of HVTN 115 baseline ADCP score, 1)) and 2) Average ADCP score > 3x antigen specific median HVTN 115 baseline average ADCP score. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Magnitude of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. | Measured at month 13, 2 weeks after the 5th vaccination. |
| Violari A, Otwombe K, Hahn W, Chen S, Josipovic D, Baba V, Angelidou A, Smolen KK, Levy O, Mkhize NN, Woodward AS, Martin TM, Haynes B, Williams WB, Sagawa ZK, Kublin J, Polakowski L, Isaacs MB, Yen C, Tomaras G, Corey L, Janes H, Gray G. Safety and implementation of a phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns. medRxiv [Preprint]. 2024 Oct 17:2024.10.15.24315548. doi: 10.1101/2024.10.15.24315548. |
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| FG002 | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| FG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| FG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
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| COMPLETED | The values reported reflect the number of infants, who were the primary participants. Each infant corresponds to one unique mother, so the number of mothers equals the number of infants. |
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| NOT COMPLETED |
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Baseline characteristics are presented separately for mothers and infants. Mothers were enrolled to assess maternal HIV antibody response and did not receive study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54 |
| BG001 | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| BG002 | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| BG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| BG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of Infants (Continuous) | Median | Full Range | days |
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| Age, Continuous | Age of Mothers (Continuous) | Median | Full Range | years |
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| Sex: Female, Male | Sex of Infants (Female, Male) | Count of Participants | Participants |
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| Sex: Female, Male | Sex of Mothers (Female, Male) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity of Infants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity of Mothers | Count of Participants | Participants |
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| Race (NIH/OMB) | Race of Infants | Count of Participants | Participants |
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| Race (NIH/OMB) | Race of Mothers | Count of Participants | Participants |
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| Region of Enrollment | Region of Enrollment of Infants | Count of Participants | Participants |
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| Region of Enrollment | Region of Enrollment of Mothers | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | WHO Anthropometric Measure of Weight-for-Age Z-Score | At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score will be calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. This Outcome Measure was not collected for Mothers. | Safety population | Posted | Median | Full Range | Z-scores | Measured at each study visit. |
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| Primary | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. Z-scores less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. | Safety population | Posted | Count of Participants | Participants | Measured at each study visit. |
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| Primary | WHO Anthropometric Measure of Weight-for-Length Z-Score | At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. This Outcome Measure was not collected for Mothers. | Safety population | Posted | Median | Full Range | Z-scores | Measured at each study visit. |
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| Primary | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. Z-scores less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. | Safety population | Posted | Count of Participants | Participants | Measured at each study visit. |
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| 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. This Outcome Measure was not collected for Mothers. | Safety population | Posted | Count of Participants | Participants | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). |
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| 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. This Outcome Measure was not collected for Mothers. | Safety population | Posted | Count of Participants | Participants | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). |
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| 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: fever, sleepiness/lethargy, rash, vomiting, anorexia, seizure. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities for a participant. This Outcome Measure was not collected for Mothers. | Safety population | Posted | Count of Participants | Participants | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). |
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| Primary | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point. This Outcome Measure was not collected for Mothers. | '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. | Posted | Count of Participants | Participants | ALT, creatinine, hemoglobin, platelets, and WBC measured at Screening (Day 0) and Days 14, 70, 126, 238, 393, 743; Lymphocytes and Neutrophils measured at Days 14, 70, 126, 238, 393, 743. |
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| Primary | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). This Outcome Measure was not collected for Mothers. | Safety population | Posted | Count of Participants | Participants | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. |
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| Primary | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). This Outcome Measure was not collected for Mothers. | Safety population | Posted | Count of Participants | Participants | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). This Outcome Measure was not collected for Mothers. | Safety population | Posted | Count of Participants | Participants | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. |
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| Primary | Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination | Serum HIV-1-specific IgG responses were measured on a BioPlex instrument (BioRad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Net MFI less than 1 is set to 1, and net MFI > 22,000 is set to 22,000. The area under the curve (AUC) was calculated for each participant and antigen using the trapezoidal rule, where the x-axis is log10 dilution and the y-axis is the Net MFI with negative values set to 0. AUC is considered the primary measure of response magnitude. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | net MFI*log10(dilution) | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Primary | Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination | HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 3rd vaccination, who were HIV-uninfected and received the 3rd vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | Percentage of B cells | Measured at month 4.5 (2 weeks post the 3rd vaccination). |
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| Primary | Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations | HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the 5th vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | Percentage of B cells | Measured at month 13 (2 weeks after the 5th vaccination). |
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| Secondary | EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus) | PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against diphtheria, tetanus, pertussis, and rubella. The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. A Hepatitis B antigen was tested as part of the PVMA panel, but did not pass lab-internal QC. The lab opted to test this antigen via ELISA and reported those calculated concentration data for analysis in lieu of the HepB PVMA data. A HepB standard was used in each assay for quality control. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants who received all relevant recommended EPI vaccine doses prior to month 13 for a given antigen. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | IU/mL | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (HiB and RSV) | PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against Haemophilus influenzae type B (HiB) and respiratory syncytial virus (RSV). The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants who received all relevant recommended EPI vaccine doses prior to month 13 for a given antigen. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | µg/mL | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination. | Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. All serum samples were assayed against Tier 1 and Tier 2 strains of virus by starting with a 1:10 dilution of serum to obtain a neutralizing antibody titer. ID50 (ID80) titers are defined as the serum dilution that reduces RLUs by 50% (or 80%) relative to the RLUs in virus control wells after subtraction of background. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | Titers | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination | Serum HIV-1-specific FcR responses (1:50 dilution) were measured using the standardized custom HIV-1 Luminex assay on a Luminex FLEXMAP 3D system. Readouts were background-subtracted mean fluorescence intensity (MFI), with background defined by plate-level controls. Net MFI was calculated as experimental minus reference antigen MFI, and values <1 were set to 1. Post-enrollment samples were considered positive if they met all three criteria: (1) Net MFI ≥ antigen-specific cutoff (95th percentile of HVTN 115 Part A baseline at Day 0) and ≥ 100 above blank; (2) Net MFI > 3 times the median baseline Net MFI; and (3) MFI > 3 times the median baseline MFI. Response calls were based on the 1:50 dilution. Data were excluded if the blood draw was outside the allowable window, the participant was HIV positive, reference antigen MFI > 5,000, or baseline net MFI > 6,500. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Count of Participants | Participants | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination | Serum HIV-1-specific FcR (dilution 1:50) responses were measured on a Luminex FLEXMAP 3D Instrument System using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. 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. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination | The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to %GzB activity. A positive response is defined as ≥ 8% GzB activity. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Count of Participants | Participants | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination | The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | Peak Net % Granzyme B Activity | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination | ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 * (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to percent killing or loss of luciferase activity. A positive response is defined as percent specific killing ≥ 15%. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Count of Participants | Participants | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination | ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 * (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | Peak % loss luciferase activity | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Response Rate of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. Positivity calls were based on two criteria: 1) Average ADCP score ≥ antigen specific cutoff values (max(95th percentile of HVTN 115 baseline ADCP score, 1)) and 2) Average ADCP score > 3x antigen specific median HVTN 115 baseline average ADCP score. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Count of Participants | Participants | Measured at month 13, 2 weeks after the 5th vaccination. |
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| Secondary | Magnitude of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. | "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses. | Posted | Median | Inter-Quartile Range | Mean phagocytosis score | Measured at month 13, 2 weeks after the 5th vaccination. |
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The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54 | 0 | 10 | 3 | 10 | 10 | 10 |
| EG001 | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 0 | 2 | 1 | 2 | 2 | 2 |
| EG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 0 | 16 | 2 | 16 | 16 | 16 |
| EG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 0 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Intestinal sepsis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Ophthalmia neonatorum | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Post-tussive vomiting | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Vomiting (Solicited) | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Injection site erythema (Solicited) | General disorders | MedDRA 27 | Systematic Assessment |
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| Injection site pain (Solicited) | General disorders | MedDRA 27 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Pyrexia (Solicited) | General disorders | MedDRA 27 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.1 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 26.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Decreased appetite (Solicited) | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Somnolence (Solicited) | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Rash (Solicited) | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations | Fred Hutchinson Cancer Center | 2066675812 | hvtn.covpn.sdmc@hvtn.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2025 | May 20, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608161 | glucopyranosyl lipid-A |
Not provided
Not provided
Not provided
| Male |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Month 0/Prior to Vaccination 1 |
|
| 1 Day Post Vaccination 1 |
|
| 14 Days Post Vaccination 1 |
|
| Month 2/Prior to Vaccination 2 |
|
| 14 Days Post Vaccination 2 |
|
| Month 4/Prior to Vaccination 3 |
|
| 14 Days Post Vaccination 3 |
|
| Month 8/Prior to Vaccination 4 |
|
| 14 Days Post Vaccination 4 |
|
| Month 12.5/Prior to Vaccination 5 |
|
| 14 Days Post Vaccination 5 |
|
| 4.5 Months Post Vaccination 5 |
|
| 12.5 Months Post Vaccination 5 |
|
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
| OG002 | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG003 | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG004 | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) |
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG001 | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) |
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG001 | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) |
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| OG001 | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
|
| Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) |
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG002 | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
| OG003 | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 |
|
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|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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