HIV InfectionsPhase 1HVTN 135NCT04607408

Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants

A Phase 1 study testing CH505TF gp120 and GLA-SE adjuvant in people with HIV Infections, run by HIV Vaccine Trials Network at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 0 to 5 daysHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: CH505TF gp120 and GLA-SE adjuvant
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteSouth Africa
Study dates: 10 Nov 2020to 24 Jul 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 5 days
All sexes
Healthy volunteers accepted
Child

Infant Inclusion Criteria:

Born via Caesarean section to an HIV-1-infected woman who meets all maternal inclusion/exclusion criteria listed below.
Estimated gestational age at birth is at least 37 weeks.
Weight at birth is at least 2.5 kg.
Has initiated antiretroviral prophylaxis consistent with current site-specific standard of care.
Hemoglobin >14.0 g/dL.
White Blood Cell Count ≥ 7000 cells/mm3
Platelets > 100,000 cells/mm3
Alanine aminotransferase (ALT) <1.25 times upper limit of age adjusted normal.
Creatinine < 1.1 times upper limit of age adjusted normal.
Negative HIV-1 nucleic acid test on specimen drawn within 72 hours of birth.
Written informed consent provided by mother.
Age is equal to or less than five days.

Infant Exclusion Criteria:

Any clinically significant congenital anomaly/birth defect.
Documented or suspected serious medical illness, infection, clinically significant finding from physical examination or immediate life-threatening condition, including requirement for ongoing supplemental oxygen, as judged by the examining clinician.
Receipt of or anticipated need for blood products, immunoglobulin, or immunosuppressive therapy. This includes infants who require Hepatitis B Immunoglobulin (HBIG) but does not require exclusion of infants who receive Hepatitis B vaccine in the newborn period.
Receipt of any other investigational product.

Mother Inclusion Criteria:

Mother's age is at least 18 years, and willing and able to provide written informed consent for her and her infant's participation in this study.
Mother is in the second or third trimester of singleton pregnancy, as determined by a clinical exam, or sonography and reported menstrual history.
Mother agrees to donate umbilical cord blood.
Mother has a planned Caesarian Section at Chris Hani Baragwanath Academic Hospital, Soweto and plans to remain in the area after delivery.
Mother is determined by the site investigator to be in good overall health at the time of delivery based on medical history, and physical exam.
Mother has a documented CD4 count > 350 cells/microliter during her pregnancy.
Mother has a documented SARS-CoV-2 negative PCR test within 2 days before delivery to 5 days after delivery
Mother has access to the participating HVTN CRS and willingness to be followed for the planned duration of the study.
Assessment of understanding: Mother demonstrates understanding of this study; completes a questionnaire prior to delivery with verbal demonstration of understanding of all questionnaire items answered incorrectly.
Mother agrees not to enroll either herself or her infant in another research study for the duration of the trial without prior approval of the HVTN 135 PSRT.
Mother has confirmed HIV-1 infection documented by medical records at any time during or prior to screening, and confirmed by the HVTN CRS by serology.
Mother has been on cART for at least sixteen weeks prior to delivery and intends to continue with cART for the duration of breastfeeding.\
Mother has a viral load of less than 400 copies/mL between two weeks before and 5 days after delivery.

Mother Exclusion Criteria:

Any WHO Grade IV illness within one year prior to study enrollment as determined by the history and physical examination and review of the medical record (if available). These include HIV wasting syndrome, PJP Pneumonia, Cerebral Toxoplasmosis, extrapulmonary Cryptococcosis, Progressive Multifocal Leukoencephalopathy, any disseminated endemic mycosis (histoplasmosis), candidiasis of the esophagus, trachea, bronchi or lung, disseminated atypical mycobacteria, non-typhoid Salmonella septicemia, extrapulmonary tuberculosis, lymphoma, Kaposi's sarcoma.
Prior participation in any HIV-1 vaccine or anti-HIV antibody-mediated prevention trial.
Receipt of any investigational agent during this pregnancy.
Receipt of blood products, immunoglobulin, or immunomodulating therapy within 45 days prior to delivery of the placenta.
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent.
Any condition that places the newborn at higher risk of early-onset sepsis, such as concern for active maternal infection at delivery as determined by local site investigators (eg, fever).
Detectable Hepatitis B surface antigen.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Perinatal HIV Research Unit (PHRU), Soweto CRS
Johannesburg, Gauteng, 1862

Other trials in South Africa

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants

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.

Read the detailed description

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.

Conditions: HIV Infections
Being tested: CH505TF gp120, GLA-SE adjuvant, Placebo
Keywords: HIV, Vaccine, Infant
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CH505TF gp120Biological
HIV-1 CH505 transmitted/founder virus Env gp120 immunogen
GLA-SE adjuvantBiological
An oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA)
PlaceboBiological
Sodium Chloride for Injection, 0.9% USP

Study groups in NCT04607408
Study group	Role	What they receive
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. Receives: Biological: CH505TF gp120; Biological: GLA-SE adjuvant
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. Receives: Biological: Placebo
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. Receives: Biological: CH505TF gp120; Biological: GLA-SE adjuvant
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. Receives: Biological: Placebo
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. Receives: Biological: CH505TF gp120; Biological: GLA-SE adjuvant
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. Receives: Biological: Placebo
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. Receives: Biological: CH505TF gp120; Biological: GLA-SE adjuvant
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. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: 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: 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.
Measured: 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: 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: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: 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: 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: Measured at month 13 (2 weeks after the 5th vaccination).

Secondary outcomes (11)

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.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at month 13, 2 weeks after the 5th vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Nov 202024 Jul 2024

First posted29 Oct 2020
Study start10 Nov 2020
Primary completion24 Jul 2024
Study completion24 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04607408
Sponsor's protocol ID: HVTN 135
Other IDs: UM1AI068614
Acronym: HVTN 135
Status last verified: Jan 2026
First submitted: 16 Oct 2020
Last updated: 29 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 40178906
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.
PubMed 39484284

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants
ClinicalTrials.gov ID: NCT04607408
Acronym / sponsor ID: HVTN 135 / HVTN 135
Conditions: HIV Infections
Keywords: HIV, Vaccine, Infant
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: HIV Vaccine Trials NetworkResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 10 Nov 2020 (actual)
Primary completion: 24 Jul 2024 (actual)
Study completion: 24 Jul 2024 (actual)
First posted: 29 Oct 2020 (actual)
Results: Posted 6 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Part A, Group 1: CH505TF gp120 + GLA-SE	Experimental	Biological: CH505TF gp120, Biological: GLA-SE adjuvantParticipants 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.
Part A, Group 2: Placebo	Placebo comparator	Biological: PlaceboParticipants received Placebo administered as a 0.25 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Part B, Group 3: CH505TF gp120 + GLA-SE	Experimental	Biological: CH505TF gp120, Biological: GLA-SE adjuvantParticipants 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.
Part B, Group 4: Placebo	Placebo comparator	Biological: PlaceboParticipants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Part C, Group 5: CH505TF gp120 + GLA-SE	Experimental	Biological: CH505TF gp120, Biological: GLA-SE adjuvantParticipants 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.
Part C, Group 6: Placebo	Placebo comparator	Biological: PlaceboParticipants 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	Biological: CH505TF gp120, Biological: GLA-SE adjuvantParticipants 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.
Part C, Group 8: Placebo	Placebo comparator	Biological: PlaceboParticipants received Placebo administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.

Who may qualify

Ages: 0 to 5 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CH505TF gp120HIV-1 CH505 transmitted/founder virus Env gp120 immunogen	Biological	Part A, Group 1: CH505TF gp120 + GLA-SE, Part B, Group 3: CH505TF gp120 + GLA-SE, Part C, Group 5: CH505TF gp120 + GLA-SE, Part C, Group 7: CH505TF gp120 + GLA-SE
GLA-SE adjuvantAn oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA)	Biological	Part A, Group 1: CH505TF gp120 + GLA-SE, Part B, Group 3: CH505TF gp120 + GLA-SE, Part C, Group 5: CH505TF gp120 + GLA-SE, Part C, Group 7: CH505TF gp120 + GLA-SE
PlaceboSodium Chloride for Injection, 0.9% USP	Biological	Part A, Group 2: Placebo, Part B, Group 4: Placebo, Part C, Group 6: Placebo, Part C, Group 8: Placebo

Primary outcome

WHO Anthropometric Measure of Weight-for-Age Z-Score
Time frame: Measured at each study visit.
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.
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
Time frame: Measured at each study visit.
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.
WHO Anthropometric Measure of Weight-for-Length Z-Score
Time frame: Measured at each study visit.
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.
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
Time frame: Measured at each study visit.
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.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).
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.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Time frame: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).
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.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Time frame: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).
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.
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.
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.
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.
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
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.
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.
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
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.
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.
Number of Participants Reporting Serious Adverse Events (SAEs)
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.
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.
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
Time frame: Measured at month 13, 2 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.
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
Time frame: Measured at month 4.5 (2 weeks post 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+.
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
Time frame: Measured at month 13 (2 weeks after the 5th 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+.

11 secondary outcomes

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)
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)
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.
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
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
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
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
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
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
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
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
Time frame: Measured at month 13, 2 weeks after the 5th vaccination.

Results and safety

Results posted to the registry on 6 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)	10	10
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)	5	4
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)	2	2
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)	16	14
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)	5	5

Primary outcome: WHO Anthropometric Measure of Weight-for-Age Z-Score

Time frame: Measured at each study visit.. Median (Full Range). Unit: Z-scores

Measure	Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) n = 10	Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) n = 5	Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 2	Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 16	Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 5
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)

Population analysed: Safety population

Primary outcome: Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories

Time frame: Measured at each study visit.. Count of participants. Unit: Participants

Measure	Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) n = 10	Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) n = 5	Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 2	Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 16	Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 5
<-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

Population analysed: Safety population

Primary outcome: WHO Anthropometric Measure of Weight-for-Length Z-Score

Time frame: Measured at each study visit.. Median (Full Range). Unit: Z-scores

Measure	Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) n = 10	Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) n = 5	Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 2	Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 16	Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 5
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)

Population analysed: Safety population

Primary outcome: Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories

Time frame: Measured at each study visit.. Count of participants. Unit: Participants

Measure	Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) n = 10	Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) n = 5	Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 2	Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 16	Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) n = 5
<-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

Population analysed: Safety population

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)	3 of 10 (30%)	10 of 10 (100%)	0 of 10
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)	2 of 16 (12.5%)	16 of 16 (100%)	0 of 16
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)	0 of 5 (0%)	5 of 5 (100%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40178906Violari 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.
Derived from this study: PubMed 39484284Violari 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.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Avy Violari study chair

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Georgia Tomaras study chair

Duke University, HVTN Laboratory

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CH505TF gp120 and GLA-SE adjuvant in people with HIV Infections, run by HIV Vaccine Trials Network at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WHO Anthropometric Measure of Weight-for-Age Z-Score (time frame: Measured at each study visit.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607408, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.