A Phase 1 interventional study of CH505TF gp120 and GLA-SE adjuvant in HIV Infections, sponsored by HIV Vaccine Trials Network. Completed at 1 site in South Africa. Open to participants aged 0 Days to 5 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by HIV Vaccine Trials Network · Phase 1, Interventional, and Prevention
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 38 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →HIV Vaccine Trials Network is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Infant Inclusion Criteria:
Infant Exclusion Criteria:
Mother Inclusion Criteria:
Mother Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: CH505TF gp120 · Biological: GLA-SE adjuvant
Participants received Placebo administered as a 0.25 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Biological: Placebo
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.
Biological: CH505TF gp120 · Biological: GLA-SE adjuvant
Participants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Biological: Placebo
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.
Biological: CH505TF gp120 · Biological: GLA-SE adjuvant
Participants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Biological: Placebo
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.
Biological: CH505TF gp120 · Biological: GLA-SE adjuvant
Participants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Biological: Placebo
HIV-1 CH505 transmitted/founder virus Env gp120 immunogen
An oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA)
Sodium Chloride for Injection, 0.9% USP
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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at each study visit.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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+.
Time frame: 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+.
Time frame: 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 (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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Measured at month 13, 2 weeks after the 5th vaccination.
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.
| Milestone | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Started | 10 | 5 | 2 | 16 | 5 |
| Completed | 10 | 4 | 2 | 14 | 5 |
| Not completed | 0 | 1 | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 | 0 |
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.
| Z-scores | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Screening Visit | -0.32 (-1.15 to 1.47) | -0.80 (-1.54 to 0.51) | -1.59 (-2.1 to -1.08) | -0.29 (-1.47 to 0.82) | 0.60 (-1.22 to 0.87) |
| Month 0/Prior to Vaccination 1 | -0.54 (-1.9 to 1.39) | -1.16 (-1.51 to 0.45) | -1.36 (-1.72 to -0.99) | -0.47 (-2.41 to 1.46) | 0.06 (-1.25 to 0.74) |
| 1 Day Post Vaccination 1 | -0.47 (-1.96 to 1.28) | -1.13 (-1.57 to 0.39) | -1.39 (-1.81 to -0.96) | -0.44 (-1.31 to 0.52) | -0.05 (-1.09 to 0.73) |
| 14 Days Post Vaccination 1 | -0.50 (-2.14 to 1.42) | -0.53 (-1.55 to 0.89) | -1.02 (-1.09 to -0.95) | -0.29 (-1.37 to 0.83) | 0.03 (-0.61 to 0.4) |
| Month 2/Prior to Vaccination 2 | -0.25 (-2.06 to 1.44) | 0.15 (-1.8 to 0.98) | -1.27 (-1.34 to -1.2) | -0.34 (-1.47 to 1.3) | 0.07 (-0.54 to 0.55) |
| 14 Days Post Vaccination 2 | -0.50 (-2.04 to 1.68) | 0.22 (-1.78 to 0.7) | -1.30 (-1.4 to -1.2) | 0.02 (-1.23 to 1.52) | -0.04 (-0.47 to 0.68) |
| Month 4/Prior to Vaccination 3 | -0.04 (-2.2 to 1.64) | -0.44 (-1.02 to 0.35) | -1.43 (-1.69 to -1.16) | -0.38 (-1.39 to 1.67) | -0.31 (-3.16 to 1.05) |
| 14 Days Post Vaccination 3 | 0.11 (-1.49 to 1.78) | -0.56 (-1.34 to 0.37) | -1.41 (-1.43 to -1.39) | -0.39 (-1.56 to 1.69) | 0.24 (-0.33 to 1.1) |
| Month 8/Prior to Vaccination 4 | 0.12 (-2.02 to 1.72) | -0.76 (-1.37 to 0.76) | -1.69 (-1.89 to -1.49) | -0.09 (-1.08 to 2.24) | 0.60 (-0.72 to 1.73) |
| 14 Days Post Vaccination 4 | 0.23 (-1.82 to 1.67) | -0.69 (-1.41 to 0.75) | -1.71 (-1.73 to -1.69) | -0.04 (-1.28 to 2.29) | -0.20 (-0.72 to 1.59) |
| Month 12.5/Prior to Vaccination 5 | -0.03 (-1.87 to 1.67) | -0.25 (-1.83 to 0.13) | -1.30 (-1.32 to -1.27) | 0.29 (-1.61 to 2.2) | -0.14 (-0.48 to 1.35) |
| 14 Days Post Vaccination 5 | -0.18 (-1.74 to 1.6) | -0.39 (-1.9 to 0.12) | -1.20 (-1.2 to -1.2) | 0.52 (-1.49 to 2.29) | 0.14 (-0.43 to 1.87) |
| 4.5 Months Post Vaccination 5 | -0.27 (-1.87 to 1.48) | -1.17 (-2.38 to 0.21) | -1.28 (-1.37 to -1.18) | -0.11 (-1.24 to 2.01) | 1.08 (-0.33 to 2.53) |
| 12.5 Months Post Vaccination 5 | -0.05 (-1.83 to 1.32) | -0.70 (-2.06 to -0.37) | -0.08 (-0.89 to 0.74) | 0.14 (-1.03 to 1.64) | 0.24 (-0.48 to 0.97) |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| <-2 (Screening Visit) | 0 | 0 | 1 | 0 | 0 |
| -2 to 2 (Screening Visit) | 10 | 5 | 1 | 16 | 5 |
| >2 (Screening Visit) | 0 | 0 | 0 | 0 | 0 |
| <-2 (Month 0/Prior to Vaccination 1) | 0 | 0 | 0 | 1 | 0 |
| -2 to 2 (Month 0/Prior to Vaccination 1) | 10 | 5 | 2 | 15 | 5 |
| >2 (Month 0/Prior to Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| <-2 (1 Day Post Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (1 Day Post Vaccination 1) | 10 | 5 | 2 | 16 | 5 |
| >2 (1 Day Post Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| <-2 (14 Days Post Vaccination 1) | 1 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 1) | 9 | 5 | 2 | 16 | 5 |
| >2 (14 Days Post Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| <-2 (Month 2/Prior to Vaccination 2) | 1 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 2/Prior to Vaccination 2) | 9 | 5 | 2 | 15 | 5 |
| >2 (Month 2/Prior to Vaccination 2) | 0 | 0 | 0 | 0 | 0 |
| <-2 (14 Days Post Vaccination 2) | 1 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 2) | 9 | 5 | 2 | 15 | 5 |
| >2 (14 Days Post Vaccination 2) | 0 | 0 | 0 | 0 | 0 |
| <-2 (Month 4/Prior to Vaccination 3) | 1 | 0 | 0 | 0 | 1 |
| -2 to 2 (Month 4/Prior to Vaccination 3) | 8 | 5 | 2 | 15 | 3 |
| >2 (Month 4/Prior to Vaccination 3) | 0 | 0 | 0 | 0 | 0 |
| <-2 (14 Days Post Vaccination 3) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 3) | 9 | 5 | 2 | 15 | 4 |
| >2 (14 Days Post Vaccination 3) | 0 | 0 | 0 | 0 | 0 |
| <-2 (Month 8/Prior to Vaccination 4) | 1 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 8/Prior to Vaccination 4) | 9 | 5 | 2 | 13 | 5 |
| >2 (Month 8/Prior to Vaccination 4) | 0 | 0 | 0 | 1 | 0 |
| <-2 (14 Days Post Vaccination 4) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 4) | 10 | 5 | 2 | 13 | 5 |
| >2 (14 Days Post Vaccination 4) | 0 | 0 | 0 | 1 | 0 |
| <-2 (Month 12.5/Prior to Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 12.5/Prior to Vaccination 5) | 10 | 5 | 2 | 12 | 5 |
| >2 (Month 12.5/Prior to Vaccination 5) | 0 | 0 | 0 | 1 | 0 |
| <-2 (14 Days Post Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 5) | 9 | 5 | 1 | 12 | 5 |
| >2 (14 Days Post Vaccination 5) | 0 | 0 | 0 | 1 | 0 |
| <-2 (4.5 Months Post Vaccination 5) | 0 | 1 | 0 | 0 | 0 |
| -2 to 2 (4.5 Months Post Vaccination 5) | 10 | 3 | 2 | 13 | 4 |
| >2 (4.5 Months Post Vaccination 5) | 0 | 0 | 0 | 1 | 1 |
| <-2 (12.5 Months Post Vaccination 5) | 0 | 1 | 0 | 0 | 0 |
| -2 to 2 (12.5 Months Post Vaccination 5) | 10 | 2 | 2 | 14 | 5 |
| >2 (12.5 Months Post Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
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.
| Z-scores | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Screening Visit | 0.97 (-1.19 to 2.32) | -0.95 (-1.63 to 1.08) | -2.30 (-2.37 to -2.22) | 0.50 (-4.04 to 2.84) | 0.93 (-2.94 to 1.75) |
| Month 0/Prior to Vaccination 1 | 0.20 (-1.51 to 1.57) | -0.44 (-1.63 to 1.08) | -0.68 (-1.47 to 0.11) | 0.02 (-1.27 to 1.73) | 0.44 (-2.37 to 1.56) |
| 1 Day Post Vaccination 1 | 0.40 (-1.4 to 1.69) | 0.44 (-1.47 to 1.7) | -0.58 (-1.43 to 0.27) | 0.06 (-1.5 to 1.68) | 0.05 (-2.17 to 1.33) |
| 14 Days Post Vaccination 1 | 0.53 (-1.02 to 2.82) | 0.84 (-1.8 to 1.16) | 0.50 (-0.01 to 1) | 0.74 (-0.79 to 3.1) | 0.47 (0.14 to 1.76) |
| Month 2/Prior to Vaccination 2 | 1.07 (0.54 to 3.36) | 2.43 (-0.2 to 4.95) | 0.89 (0.35 to 1.42) | 1.60 (-0.09 to 3.21) | 1.25 (0.62 to 3.71) |
| 14 Days Post Vaccination 2 | 1.14 (0.04 to 2.2) | 1.11 (-0.33 to 2.85) | 0.88 (0.67 to 1.08) | 1.41 (0.1 to 3.36) | 1.88 (0.57 to 2.65) |
| Month 4/Prior to Vaccination 3 | 1.55 (0.1 to 2.17) | 0.91 (0.21 to 1.48) | 0.82 (0.23 to 1.41) | 1.04 (-1.26 to 4.41) | 0.99 (0.21 to 3.85) |
| 14 Days Post Vaccination 3 | 1.55 (-0.06 to 2.21) | 0.48 (-0.52 to 1.98) | -0.02 (-0.69 to 0.65) | 1.16 (-0.99 to 2.91) | 0.69 (0.27 to 2.15) |
| Month 8/Prior to Vaccination 4 | 1.07 (-1.42 to 2.88) | 0.67 (0.56 to 1.83) | -0.49 (-0.82 to -0.16) | 1.01 (-0.96 to 2.71) | 0.96 (0.44 to 2.9) |
| 14 Days Post Vaccination 4 | 1.11 (-1.13 to 3) | 0.68 (-0.07 to 1.52) | 0.18 (-0.62 to 0.97) | 0.69 (-1.07 to 2.83) | 0.45 (0.3 to 2.6) |
| Month 12.5/Prior to Vaccination 5 | 0.96 (-1.27 to 3.25) | 0.91 (-0.1 to 1.72) | -0.04 (-0.52 to 0.44) | 0.79 (-0.56 to 2.79) | 1.39 (-0.59 to 2.72) |
| 14 Days Post Vaccination 5 | 0.66 (-0.96 to 2.6) | 0.93 (-0.39 to 1.83) | 0.63 (0.63 to 0.63) | 0.65 (-0.45 to 2.93) | 1.71 (-0.41 to 2.58) |
| 4.5 Months Post Vaccination 5 | 0.68 (-1.27 to 2.44) | 0.08 (-0.59 to 1.29) | -0.36 (-0.58 to -0.13) | 0.89 (-0.4 to 2.25) | 0.79 (-0.61 to 2.69) |
| 12.5 Months Post Vaccination 5 | 1.06 (-1.26 to 2.24) | 0.72 (0 to 0.83) | 0.59 (0.34 to 0.83) | 1.05 (-0.2 to 2.27) | 1.70 (-0.26 to 3) |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| <-2 (Screening Visit) | 0 | 0 | 2 | 1 | 1 |
| -2 to 2 (Screening Visit) | 8 | 5 | 0 | 12 | 3 |
| >2 (Screening Visit) | 1 | 0 | 0 | 2 | 0 |
| <-2 (Month 0/Prior to Vaccination 1) | 0 | 0 | 0 | 0 | 1 |
| -2 to 2 (Month 0/Prior to Vaccination 1) | 10 | 5 | 2 | 15 | 3 |
| >2 (Month 0/Prior to Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| <-2 (1 Day Post Vaccination 1) | 0 | 0 | 0 | 0 | 1 |
| -2 to 2 (1 Day Post Vaccination 1) | 10 | 5 | 2 | 15 | 4 |
| >2 (1 Day Post Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| <-2 (14 Days Post Vaccination 1) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 1) | 9 | 5 | 2 | 14 | 5 |
| >2 (14 Days Post Vaccination 1) | 1 | 0 | 0 | 2 | 0 |
| <-2 (Month 2/Prior to Vaccination 2) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 2/Prior to Vaccination 2) | 8 | 1 | 2 | 10 | 3 |
| >2 (Month 2/Prior to Vaccination 2) | 2 | 4 | 0 | 5 | 2 |
| <-2 (14 Days Post Vaccination 2) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 2) | 9 | 4 | 2 | 11 | 3 |
| >2 (14 Days Post Vaccination 2) | 1 | 1 | 0 | 4 | 2 |
| <-2 (Month 4/Prior to Vaccination 3) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 4/Prior to Vaccination 3) | 8 | 5 | 2 | 12 | 3 |
| >2 (Month 4/Prior to Vaccination 3) | 1 | 0 | 0 | 3 | 1 |
| <-2 (14 Days Post Vaccination 3) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 3) | 7 | 5 | 2 | 13 | 3 |
| >2 (14 Days Post Vaccination 3) | 2 | 0 | 0 | 2 | 1 |
| <-2 (Month 8/Prior to Vaccination 4) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 8/Prior to Vaccination 4) | 8 | 5 | 2 | 12 | 3 |
| >2 (Month 8/Prior to Vaccination 4) | 2 | 0 | 0 | 2 | 2 |
| <-2 (14 Days Post Vaccination 4) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 4) | 8 | 5 | 2 | 11 | 3 |
| >2 (14 Days Post Vaccination 4) | 2 | 0 | 0 | 3 | 2 |
| <-2 (Month 12.5/Prior to Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (Month 12.5/Prior to Vaccination 5) | 8 | 5 | 2 | 12 | 4 |
| >2 (Month 12.5/Prior to Vaccination 5) | 2 | 0 | 0 | 1 | 1 |
| <-2 (14 Days Post Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (14 Days Post Vaccination 5) | 7 | 5 | 1 | 12 | 3 |
| >2 (14 Days Post Vaccination 5) | 2 | 0 | 0 | 1 | 2 |
| <-2 (4.5 Months Post Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (4.5 Months Post Vaccination 5) | 9 | 4 | 2 | 11 | 3 |
| >2 (4.5 Months Post Vaccination 5) | 1 | 0 | 0 | 3 | 2 |
| <-2 (12.5 Months Post Vaccination 5) | 0 | 0 | 0 | 0 | 0 |
| -2 to 2 (12.5 Months Post Vaccination 5) | 9 | 3 | 2 | 12 | 3 |
| >2 (12.5 Months Post Vaccination 5) | 1 | 0 | 0 | 2 | 2 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| None | 9 | 4 | 2 | 12 | 5 |
| Mild | 1 | 1 | 0 | 3 | 0 |
| Moderate | 0 | 0 | 0 | 1 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 |
| Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Erythema/redness — None | 10 | 3 | 2 | 16 | 5 |
| Erythema/redness — Mild | 0 | 2 | 0 | 0 | 0 |
| Erythema/redness — Moderate | 0 | 0 | 0 | 0 | 0 |
| Erythema/redness — Severe | 0 | 0 | 0 | 0 | 0 |
| Erythema/redness — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Induration/swelling — None | 10 | 5 | 2 | 16 | 5 |
| Induration/swelling — Mild | 0 | 0 | 0 | 0 | 0 |
| Induration/swelling — Moderate | 0 | 0 | 0 | 0 | 0 |
| Induration/swelling — Severe | 0 | 0 | 0 | 0 | 0 |
| Induration/swelling — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Erythema and/or Induration — None | 10 | 3 | 2 | 16 | 5 |
| Erythema and/or Induration — Mild | 0 | 2 | 0 | 0 | 0 |
| Erythema and/or Induration — Moderate | 0 | 0 | 0 | 0 | 0 |
| Erythema and/or Induration — Severe | 0 | 0 | 0 | 0 | 0 |
| Erythema and/or Induration — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Anorexia — None | 9 | 5 | 2 | 11 | 5 |
| Anorexia — Mild | 1 | 0 | 0 | 5 | 0 |
| Anorexia — Moderate | 0 | 0 | 0 | 0 | 0 |
| Anorexia — Severe | 0 | 0 | 0 | 0 | 0 |
| Anorexia — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Fever — None | 8 | 5 | 2 | 15 | 2 |
| Fever — Mild | 2 | 0 | 0 | 1 | 3 |
| Fever — Moderate | 0 | 0 | 0 | 0 | 0 |
| Fever — Severe | 0 | 0 | 0 | 0 | 0 |
| Fever — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Rash — None | 8 | 5 | 2 | 13 | 5 |
| Rash — Mild | 2 | 0 | 0 | 3 | 0 |
| Rash — Moderate | 0 | 0 | 0 | 0 | 0 |
| Rash — Severe | 0 | 0 | 0 | 0 | 0 |
| Rash — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Seizure — None | 10 | 5 | 2 | 16 | 5 |
| Seizure — Mild | 0 | 0 | 0 | 0 | 0 |
| Seizure — Moderate | 0 | 0 | 0 | 0 | 0 |
| Seizure — Severe | 0 | 0 | 0 | 0 | 0 |
| Seizure — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Sleepiness/lethargy — None | 7 | 5 | 2 | 13 | 3 |
| Sleepiness/lethargy — Mild | 3 | 0 | 0 | 3 | 1 |
| Sleepiness/lethargy — Moderate | 0 | 0 | 0 | 0 | 1 |
| Sleepiness/lethargy — Severe | 0 | 0 | 0 | 0 | 0 |
| Sleepiness/lethargy — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Vomiting — None | 10 | 4 | 2 | 15 | 3 |
| Vomiting — Mild | 0 | 1 | 0 | 1 | 2 |
| Vomiting — Moderate | 0 | 0 | 0 | 0 | 0 |
| Vomiting — Severe | 0 | 0 | 0 | 0 | 0 |
| Vomiting — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
| Max. Systemic Sypmtoms — None | 6 | 4 | 2 | 8 | 2 |
| Max. Systemic Sypmtoms — Mild | 4 | 1 | 0 | 8 | 2 |
| Max. Systemic Sypmtoms — Moderate | 0 | 0 | 0 | 0 | 1 |
| Max. Systemic Sypmtoms — Severe | 0 | 0 | 0 | 0 | 0 |
| Max. Systemic Sypmtoms — Potentially Life-threatening | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| ALT (U/L) - Screening | 0 | 0 | 0 | 0 | 0 |
| ALT (U/L) - Day 14 | 0 | 0 | 0 | 0 | 0 |
| ALT (U/L) - Day 70 | 0 | 0 | 0 | 0 | 0 |
| ALT (U/L) - Day 126 | 2 | 0 | 0 | 0 | 0 |
| ALT (U/L) - Day 238 | 1 | 0 | 0 | 0 | 0 |
| ALT (U/L) - Day 393 | 0 | 0 | 0 | 0 | 0 |
| ALT (U/L) - Day 743 | 0 | 0 | 0 | 0 | 0 |
| Creatinine (mg/dL) - Screening | 0 | 0 | 0 | 0 | 0 |
| Creatinine (mg/dL) - Day 14 | 1 | 0 | 0 | 1 | 0 |
| Creatinine (mg/dL) - Day 70 | 0 | 0 | 0 | 0 | 1 |
| Creatinine (mg/dL) - Day 126 | 0 | 0 | 0 | 0 | 0 |
| Creatinine (mg/dL) - Day 238 | 0 | 0 | 0 | 0 | 0 |
| Creatinine (mg/dL) - Day 393 | 0 | 0 | 0 | 0 | 0 |
| Creatinine (mg/dL) - Day 743 | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin (g/dL) - Screening | 0 | 0 | 0 | 0 | 0 |
| Hemoglobin (g/dL) - Day 14 | 7 | 0 | 1 | 7 | 3 |
| Hemoglobin (g/dL) - Day 70 | 4 | 1 | 1 | 7 | 3 |
| Hemoglobin (g/dL) - Day 126 | 2 | 0 | 1 | 2 | 0 |
| Hemoglobin (g/dL) - Day 238 | 0 | 1 | 0 | 2 | 0 |
| Hemoglobin (g/dL) - Day 393 | 1 | 0 | 0 | 1 | 0 |
| Hemoglobin (g/dL) - Day 743 | 2 | 1 | 1 | 2 | 0 |
| Lymphocytes (cells/cubic mm) - Day 14 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes (cells/cubic mm) - Day 70 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes (cells/cubic mm) - Day 126 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes (cells/cubic mm) - Day 238 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes (cells/cubic mm) - Day 393 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes (cells/cubic mm) - Day 743 | 0 | 0 | 0 | 0 | 0 |
| Neutrophils (cells/cubic mm) - Day 14 | 0 | 0 | 0 | 1 | 0 |
| Neutrophils (cells/cubic mm) - Day 70 | 1 | 1 | 0 | 0 | 0 |
| Neutrophils (cells/cubic mm) - Day 126 | 2 | 2 | 0 | 2 | 0 |
| Neutrophils (cells/cubic mm) - Day 238 | 1 | 0 | 0 | 0 | 0 |
| Neutrophils (cells/cubic mm) - Day 393 | 1 | 0 | 0 | 1 | 0 |
| Neutrophils (cells/cubic mm) - Day 743 | 0 | 0 | 0 | 0 | 0 |
| Platelets (cells/cubic mm) - Screening | 0 | 0 | 0 | 0 | 0 |
| Platelets (cells/cubic mm) - Day 14 | 0 | 0 | 0 | 0 | 0 |
| Platelets (cells/cubic mm) - Day 70 | 0 | 0 | 0 | 0 | 0 |
| Platelets (cells/cubic mm) - Day 126 | 0 | 0 | 0 | 1 | 0 |
| Platelets (cells/cubic mm) - Day 238 | 0 | 0 | 0 | 0 | 0 |
| Platelets (cells/cubic mm) - Day 393 | 0 | 0 | 0 | 0 | 0 |
| Platelets (cells/cubic mm) - Day 743 | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Screening | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Day 14 | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Day 70 | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Day 126 | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Day 238 | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Day 393 | 0 | 0 | 0 | 0 | 0 |
| WBC (cells/cubic mm) - Day 743 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Mild | 1 | 2 | 0 | 5 | 1 |
| Moderate | 5 | 2 | 1 | 7 | 4 |
| Severe | 4 | 1 | 1 | 4 | 0 |
| Potentially life-threatening | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 |
| No AE reported | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Related | 1 | 0 | 0 | 0 | 0 |
| Not Related | 9 | 5 | 2 | 16 | 5 |
| No AE reported | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs) | 3 | 0 | 1 | 2 | 0 |
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.
| net MFI*log10(dilution) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| 1086C D7gp120 | 5.2 (3.2 to 8.4) | 16956.7 (16512.5 to 26189.1) | 24059.2 (21832.9 to 30626.7) | 24508.6 (17065.5 to 26209.8) |
| CH0505 CON D7gp120 | 3 (1.4 to 6.5) | 7675.3 (6092.5 to 13038.8) | 16065.3 (12036.4 to 24331.6) | 16516.7 (15930.1 to 19086.2) |
| CH505TF.6R.SOSIP.664.v4.1 | 19 (2.9 to 221.5) | 50.8 (0.2 to 107.8) | 71.8 (17.4 to 236.6) | 167.8 (93.8 to 188.1) |
| Con 6 gp120/B | 7.5 (3.1 to 8.3) | 2333.2 (2327.7 to 2708) | 9386.3 (3803.9 to 15816.8) | 5373.1 (4490.3 to 6747.2) |
| Con S gp140 CFI | 7.2 (6.3 to 31) | 8289.3 (2393.4 to 8637.3) | 13322.4 (11569.8 to 23320.6) | 17231.6 (11565.6 to 26860.3) |
| gp41 | 2842.4 (2098.3 to 6013.8) | 1670.1 (1031.3 to 2167.9) | 2462 (1603.2 to 3552) | 2251.7 (2095.7 to 2592.4) |
| gp70 CH505TF V1V2 | 36.8 (1.9 to 91.3) | 2500.7 (826.8 to 8369.1) | 5768.7 (3342.3 to 9254.4) | 8417 (7400.9 to 22426.2) |
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+.
| Percentage of B cells | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| CD4-BS specific of B cells | 0.01 (0.01 to 0.01) | 0.02 (0.01 to 0.03) | 0.01 (0.01 to 0.01) | 0.01 (0.01 to 0.02) |
| CD4-BS specific of IgA B cells | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0.12) |
| CD4-BS specific of IgD- B cells | 0 (0 to 0.01) | 0.25 (0.06 to 0.48) | 0.03 (0.02 to 0.1) | 0.12 (0.03 to 0.36) |
| CD4-BS specific of IgG+ B cells | 0 (0 to 0) | 0.71 (0.18 to 1.41) | 0.39 (0.08 to 0.62) | 0.31 (0.06 to 0.77) |
| CD4-BS specific of Plasmablasts | 0.05 (0 to 0.06) | 0.03 (0 to 0.07) | 0 (0 to 0.02) | 0 (0 to 0.02) |
| CH505+ of B cells | 0.01 (0.01 to 0.01) | 0.09 (0.06 to 0.12) | 0.03 (0.02 to 0.05) | 0.06 (0.05 to 0.08) |
| CH505+ of IgA+ B cells | 0 (0 to 0) | 0 (0 to 0.04) | 0 (0 to 0) | 0.18 (0 to 0.51) |
| CH505+ of IgD- B cells | 0.01 (0 to 0.01) | 1.98 (1.1 to 2.78) | 0.38 (0.28 to 0.83) | 1.34 (1.1 to 2.1) |
| CH505+ of IgG+ B cells | 0 (0 to 0) | 5.98 (3.02 to 8.6) | 3.2 (1.65 to 4.76) | 5.11 (3.29 to 6.6) |
| CH505+ of Plasmablasts | 0.06 (0.02 to 0.09) | 0.08 (0.06 to 0.09) | 0.05 (0.02 to 0.07) | 0 (0 to 0.02) |
| IgG+ B cells of total B cells | 0.82 (0.61 to 0.87) | 1.41 (1.26 to 1.5) | 0.72 (0.57 to 0.94) | 1.26 (0.95 to 1.49) |
| Plasmablasts of B cells | 1.22 (0.54 to 2.13) | 1.24 (1.2 to 1.29) | 0.84 (0.57 to 1.11) | 0.78 (0.45 to 1.21) |
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+.
| Percentage of B cells | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| CD4-BS specific of B cells | 0.01 (0.01 to 0.01) | 0.01 (0.01 to 0.02) | 0.01 (0.01 to 0.01) | 0.01 (0.01 to 0.01) |
| CD4-BS specific of IgA B cells | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| CD4-BS specific of IgD- B cells | 0 (0 to 0) | 0.06 (0.05 to 0.07) | 0.06 (0.03 to 0.11) | 0.03 (0.03 to 0.04) |
| CD4-BS specific of IgG+ B cells | 0 (0 to 0) | 0.12 (0.11 to 0.12) | 0.12 (0.05 to 0.24) | 0.06 (0.04 to 0.07) |
| CD4-BS specific of Plasmablasts | 0.04 (0.03 to 0.05) | 0.02 (0 to 0.05) | 0.05 (0.04 to 0.08) | 0.02 (0.01 to 0.13) |
| CH505+ of B cells | 0.01 (0.01 to 0.01) | 0.13 (0.05 to 0.23) | 0.07 (0.04 to 0.11) | 0.09 (0.08 to 0.1) |
| CH505+ of IgA+ B cells | 0 (0 to 0.04) | 0 (0 to 0) | 0 (0 to 0.06) | 0 (0 to 0.03) |
| CH505+ of IgD- B cells | 0 (0 to 0.01) | 0.89 (0.44 to 1.88) | 0.89 (0.49 to 1.15) | 0.8 (0.79 to 0.84) |
| CH505+ of IgG+ B cells | 0 (0 to 0) | 2.17 (1.21 to 3.19) | 1.85 (1.32 to 2.78) | 1.7 (1.6 to 1.77) |
| CH505+ of Plasmablasts | 0.05 (0.04 to 0.12) | 0.09 (0.05 to 0.12) | 0.12 (0.08 to 0.16) | 0.13 (0.08 to 0.19) |
| IgG+ B cells of total B cells | 3.24 (2.87 to 3.75) | 4.42 (4.21 to 6.47) | 3.18 (2.1 to 4.07) | 4.05 (3.7 to 5.27) |
| Plasmablasts of B cells | 1.94 (1.3 to 2.37) | 1.87 (1.86 to 1.89) | 1.88 (1.49 to 2.27) | 1.47 (1.33 to 2.06) |
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.
| IU/mL | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| Diptheria | 0.5 (0.4 to 1) | 0.5 (0.4 to 0.9) | 0.3 (0.3 to 0.5) | 0.8 (0.4 to 0.9) |
| HepB | 0.7 (0.4 to 1.1) | 0.1 (0.1 to 0.7) | 0.6 (0.1 to 1) | 0.1 (0.1 to 0.5) |
| Pertussis | 5.4 (3.8 to 6.3) | 4.7 (4.1 to 6.2) | 5.8 (3.7 to 7.4) | 7.5 (7.4 to 18.4) |
| Rubella | 2.2 (1.3 to 3.2) | 1.4 (0.6 to 1.5) | 1.2 (0.6 to 2.1) | 1.4 (0.6 to 1.6) |
| Tetanus | 0.2 (0.1 to 0.3) | 0.3 (0.1 to 0.4) | 0.2 (0.1 to 0.3) | 0.2 (0.1 to 0.2) |
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.
| µg/mL | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| HiB | 0.2 (0.1 to 0.4) | 0.3 (0 to 0.8) | 0.1 (0 to 0.3) | 0 (0 to 0) |
| RSV | 0.2 (0 to 6.2) | 0.4 (0.1 to 4.7) | 4.9 (0.7 to 6.2) | 2.7 (1.7 to 4.4) |
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.
| Titers | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| CH0505TF.gly4/GnT1- ID50 | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| CH0505TF.gly4/GnT1- ID80 | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| CH0505s.G458Y.N279K.2/GnT1 ID50 | 11.9 (5 to 19.8) | 5 (5 to 31.7) | 35.4 (19.7 to 64.1) | 28.8 (26 to 36.5) |
| CH0505s.G458Y.N279K.2/GnT1 ID80 | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| CH0505s.G458Y.N279K.N280D.6/GnT1 ID50 | 17.5 (15.4 to 30.6) | 49.1 (34.1 to 64.2) | 32.3 (24 to 56.7) | 29 (25.3 to 31) |
| CH0505s.G458Y.N279K.N280D.6/GnT1 ID80 | — | 24 (24 to 24) | 12.9 (12.5 to 15.6) | — |
| CH505.w4.3 ID50 | 5 (5 to 5) | 481.7 (132.8 to 710.6) | 3961.6 (1226 to 8180.1) | 1157 (681.1 to 2971.8) |
| CH505.w4.3 ID80 | 5 (5 to 5) | 86 (22.9 to 115) | 733.9 (214.2 to 1523.5) | 349.7 (93.7 to 445.8) |
| CH505TF ID50 | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| CH505TF ID80 | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| CH505TF.gly4.S365P/GnT1- ID50 | — | 13.1 (13.1 to 13.1) | 38.8 (34.3 to 43.4) | — |
| CH505TF.gly4.S365P/GnT1- ID80 | — | — | 16.1 (16.1 to 16.1) | — |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| FcGRIIIa F158 1086C D7gp120 | 0 | 5 | 14 | 5 |
| FcGRIIIa F158 CH0505 CON D7gp120 | 0 | 4 | 14 | 5 |
| FcGRIIIa F158 CH505TF.6R.SOSIP.664.v4.1 | 0 | 0 | 0 | 0 |
| FcGRIIIa F158 Con 6 gp120/B | 0 | 0 | 8 | 2 |
| FcGRIIIa F158 Con S gp140 CFI | 0 | 3 | 14 | 4 |
| FcGRIIIa F158 gp41 | 3 | 0 | 4 | 1 |
| FcGRIIIa F158 gp70 CH505TF V1V2 | 0 | 3 | 13 | 5 |
| FcgRIIa H131 1086C D7gp120 | 0 | 5 | 14 | 5 |
| FcgRIIa H131 CH0505 CON D7gp120 | 0 | 5 | 14 | 5 |
| FcgRIIa H131 CH505TF.6R.SOSIP.664.v4.1 | 1 | 1 | 2 | 0 |
| FcgRIIa H131 Con 6 gp120/B | 0 | 5 | 12 | 5 |
| FcgRIIa H131 Con S gp140 CFI | 0 | 4 | 14 | 5 |
| FcgRIIa H131 gp41 | 7 | 2 | 9 | 3 |
| FcgRIIa H131 gp70 CH505TF V1V2 | 0 | 3 | 13 | 5 |
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.
| relative fluorescence units | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| FcGRIIIa F158 1086C D7gp120 | 1 (1 to 1) | 3258.5 (929.5 to 5954.8) | 6725.4 (5105.7 to 10016.2) | 8750.2 (5556.5 to 10306.2) |
| FcGRIIIa F158 CH0505 CON D7gp120 | 1 (1 to 1) | 859.2 (157.2 to 1342.2) | 1539.4 (673.2 to 6839.2) | 1922 (1291 to 4116) |
| FcGRIIIa F158 CH505TF.6R.SOSIP.664.v4.1 | 1 (1 to 7.5) | 8.8 (7.5 to 11) | 1.6 (1 to 3.8) | 3.8 (1 to 5.3) |
| FcGRIIIa F158 Con 6 gp120/B | 1 (1 to 1) | 15.5 (15.3 to 55.5) | 326.1 (31.5 to 3721.7) | 59 (47.8 to 788.2) |
| FcGRIIIa F158 Con S gp140 CFI | 1 (1 to 1) | 204 (1 to 512.2) | 422.2 (265.4 to 2271.2) | 1692.8 (445 to 5837.5) |
| FcGRIIIa F158 gp41 | 94.8 (47 to 138.2) | 22.5 (17.2 to 26.5) | 45.8 (27.5 to 104.8) | 49.2 (48 to 55) |
| FcGRIIIa F158 gp70 CH505TF V1V2 | 1 (1 to 7) | 1323.8 (111.2 to 9646) | 2486.1 (1038.8 to 8161.1) | 6085.2 (4409.8 to 28614.2) |
| FcgRIIa H131 1086C D7gp120 | 1 (1 to 1) | 15724.8 (10368.5 to 26417.2) | 27590.1 (24425.3 to 33806.8) | 27235.2 (23596.2 to 33032.5) |
| FcgRIIa H131 CH0505 CON D7gp120 | 1 (1 to 1) | 5262 (1516.8 to 9341.8) | 12016.9 (5570.3 to 25277) | 11767.5 (10037 to 16316.2) |
| FcgRIIa H131 CH505TF.6R.SOSIP.664.v4.1 | 3 (1 to 33.8) | 18.8 (1 to 34.2) | 9.1 (4.3 to 28.6) | 14.8 (1 to 29) |
| FcgRIIa H131 Con 6 gp120/B | 1 (1 to 4.5) | 377.5 (273 to 647.2) | 4278.2 (522.8 to 13886.9) | 860.5 (644.5 to 5295.8) |
| FcgRIIa H131 Con S gp140 CFI | 1 (1 to 4) | 4364.5 (227.5 to 5668.5) | 7722.6 (4547.6 to 19637.6) | 12558 (7184 to 25031) |
| FcgRIIa H131 gp41 | 306 (125.5 to 693.8) | 94 (65 to 104.5) | 236.6 (64.8 to 565.2) | 338.2 (48 to 383.5) |
| FcgRIIa H131 gp70 CH505TF V1V2 | 1 (1 to 2.5) | 5403.8 (311.2 to 22245.2) | 10442.4 (4374.9 to 22312.4) | 16390.8 (15740.5 to 44073.5) |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| 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 | 0 | 5 | 7 | 0 |
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.
| Peak Net % Granzyme B Activity | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| 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 | 0 (0 to 0.7) | 24.3 (21.8 to 24.5) | 8.1 (5.8 to 9.7) | 6.8 (4.5 to 7) |
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%.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| 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 | 2 | 0 | 4 | 3 |
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).
| Peak % loss luciferase activity | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| 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 | 7.9 (4.9 to 9) | 9 (7.1 to 12.6) | 13.6 (9.5 to 19.9) | 18.4 (14 to 24.7) |
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.
| Participants | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| 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 | 7 | 5 | 14 | 5 |
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.
| Mean phagocytosis score | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Groups 3+5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|
| Magnitude of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | 2.1 (1.5 to 2.5) | 14.7 (4.3 to 16.6) | 11.4 (9.1 to 13.9) | 10.9 (10.5 to 11.6) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | 0/10 (0%) | 3/10 (30%) | 10/10 (100%) |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 0/16 (0%) | 2/16 (12.5%) | 16/16 (100%) |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| BronchiolitisInfections and infestations | 0/10 | 0/5 | 1/2 | 0/16 | 0/5 |
| LymphadenitisBlood and lymphatic system disorders | 1/10 | 0/5 | 0/2 | 0/16 | 0/5 |
| Fungal skin infectionInfections and infestations | 1/10 | 0/5 | 0/2 | 0/16 | 0/5 |
| PneumoniaInfections and infestations | 1/10 | 0/5 | 0/2 | 0/16 | 0/5 |
| Intestinal sepsisInfections and infestations | 0/10 | 0/5 | 0/2 | 1/16 | 0/5 |
| Ophthalmia neonatorumInfections and infestations | 0/10 | 0/5 | 0/2 | 1/16 | 0/5 |
| Event | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 6/10 | 4/5 | 2/2 | 4/16 | 3/5 |
| Haemoglobin decreasedInvestigations | 9/10 | 3/5 | 2/2 | 12/16 | 4/5 |
| DiarrhoeaGastrointestinal disorders | 7/10 | 2/5 | 0/2 | 2/16 | 1/5 |
| Pyrexia (Solicited)General disorders | 2/10 | 0/5 | 0/2 | 1/16 | 3/5 |
| TonsillitisInfections and infestations | 0/10 | 1/5 | 0/2 | 0/16 | 3/5 |
| Neutrophil count decreasedInvestigations | 6/10 | 2/5 | 1/2 | 4/16 | 0/5 |
| HypothermiaGeneral disorders | 0/10 | 0/5 | 1/2 | 0/16 | 0/5 |
| Seasonal allergyImmune system disorders | 0/10 | 0/5 | 1/2 | 0/16 | 0/5 |
| BronchiolitisInfections and infestations | 0/10 | 0/5 | 1/2 | 0/16 | 0/5 |
| GastroenteritisInfections and infestations | 3/10 | 1/5 | 1/2 | 3/16 | 2/5 |
Baseline characteristics are presented separately for mothers and infants. Mothers were enrolled to assess maternal HIV antibody response and did not receive study product.
| Age, Continuous(days) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| Median | 4 (4 to 5) | 4 (2 to 4) | 4.5 (4 to 5) | 4 (2 to 5) | 4 (3 to 5) | 4 (2 to 5) |
| Age, Continuous(years) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| Median | 31.5 (26 to 39) | 36 (34 to 38) | 36 (35 to 37) | 34.5 (24 to 41) | 33 (25 to 36) | 34 (24 to 41) |
| Sex: Female, Male(Participants) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| Female | 6 | 1 | 1 | 9 | 1 | 18 |
| Male | 4 | 4 | 1 | 7 | 4 | 20 |
| Sex: Female, Male(Participants) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| Female | 10 | 5 | 2 | 16 | 5 | 38 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 5 | 2 | 16 | 5 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 5 | 2 | 16 | 5 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 5 | 2 | 16 | 5 | 38 |
| White | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 5 | 2 | 16 | 5 | 38 |
| White | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
2 further baseline measures are reported on the registry.
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Studies of the drug tested here: CH505TF
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