A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants

A Phase 1, Randomized, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants

This is an open-label, multicenter, randomized phase 1 study to evaluate the safety and immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV trimer mRNA. These trimers are based on the BG505 MD39 native-like trimer reported in Steichen et al. Immunity 2016. The primary hypothesis is that the BG505 MD39.3 soluble and membrane-bound trimer mRNA vaccines will be safe and well-tolerated among HIV-uninfected individuals and will elicit autologous neutralizing antibodies.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Biological: BG505 MD39.3 mRNA; Biological: BG505 MD39.3 gp151 mRNA; Biological: BG505 MD39.3 gp151 CD4KO mRNA

Detailed Description

Participants will receive BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA or BG505 MD39.3 gp151 CD4KO mRNA, at doses of 100 mcg or 250mcg, administered via intramuscular (IM) injections into the deltoid muscle. Participants will be evaluated for safety and immune responses through blood and lymph node fine-needle aspiration collection at specified timepoints throughout the study.

A dose escalation plan will be implemented, whereby sentinel safety groups for each of the three low-dose groups in Part A would be enrolled and evaluated for safety 2 weeks after the first vaccination. If safety criteria are met, then enrollment of the Part B sentinel safety groups and the remainder of the Part A participants would commence. Safety for the sentinel groups in Part B will be assessed after the first vaccination prior to full enrollment of Part B. In addition, standard safety evaluations will occur routinely throughout the trial.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • Alabama CRS [31788]
  • California
    • Los Angeles, California, United States, 90038
      • UCLA Vine Street Clinic CRS [31607]
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • BIDMC Vcrs [32077]
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital Vaccine CRS [30007]
  • New York
    • New York, New York, United States, 10065
      • New York Blood Center CRS [31801]
    • New York, New York, United States, 30329
      • Columbia P&S CRS [30329]
    • Rochester, New York, United States, 14642
      • University of Rochester Vaccines to Prevent HIV Infection CRS [31467]
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention CRS [30310]
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh CRS [1001]
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Vaccine and Prevention CRS [30331]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
2. 18-55 years old, inclusive, on day of enrollment.
3. Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
4. Agrees not to enroll in another study of an investigational agent during participation in the trial.
5. In good general health according to the clinical judgement of the site investigator.
6. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
7. Assessed as low risk for HIV acquisition per low risk guidelines, agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed for 6 months or longer.

8. Hemoglobin

   • Greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth
   • Greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months
   • Greater than or equal to 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
   • For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth
9. White blood cell (WBC) count > 3,500/mm3
10. Platelets ≥125,000 /mm3
11. Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) based on the institutional normal range
12. Serum creatinine ≤1.1 x ULN based on the institutional normal range
13. Negative results for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
14. Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected.
15. Negative for Hepatitis B surface antigen.

16. For a volunteer capable of becoming pregnant:

    • Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use effective means of birth control from at least 21 days prior to enrollment through 3 months after their third vaccination timepoint
    • Has negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to study product administration on day of enrollment.

Exclusion Criteria:

1. Volunteer who is breast-feeding or pregnant.
2. Hypertension that is not well controlled. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently < 140 mm Hg systolic and < 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be < 140 mm Hg systolic and < 90 mm Hg diastolic at enrollment. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
3. Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes).
4. Previous or current recipient of an investigational HIV vaccine (previous placebo recipients are not excluded).
5. Acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) on the day of the first vaccination. Participants meeting this criterion may be rescheduled within the enrollment window period. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
6. Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 60 mg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment).
7. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.

8. Receipt of any of the following:

   • Within 4 weeks prior to enrollment:

     • Any licensed live, attenuated vaccine
     • Any emergency use authorized (EUA) or licensed mRNA-based SARS-CoV-2 vaccine

   • Within 2 weeks prior to enrollment:

     • Any licensed killed/subunit/inactivated vaccine
     • Any EUA or licensed adenoviral-vectored or protein SARS-CoV-2 vaccines Receipt of any SARS-CoV-2 vaccination series should be completed 4 weeks prior to enrollment when possible; however, exceptions may be made by approval of the HVTN 302 PSRT.
9. Initiation of antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval.
10. Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
11. History of serious reaction (eg, hypersensitivity, anaphylaxis) to any vaccine or any component of the study vaccine.
12. History of myocarditis and/or pericarditis.
13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
14. Idiopathic urticaria within the past year.
15. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
16. Seizure disorder; febrile seizures as a child or seizures secondary to alcohol withdrawal more than 5 years ago are not exclusionary.
17. Asplenia or functional asplenia.
18. Active duty and reserve US military personnel.
19. Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, or cancer that, in the clinical judgement of the site investigator, has a potential for recurrence (excluding basal cell carcinoma).

20. Asthma is excluded if the participant has ANY of the following:

    • Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR
    • Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR
    • Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR
    • Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA]); OR
    • Uses more than one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval.
21. A participant with a history of an immune-mediated disease, either active or remote. Not exclusionary: 1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment.
22. Immunodeficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Group 1: Low dose BG505 MD39.3 mRNA; 18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6	Biological: BG505 MD39.3 mRNA; Administered by IM injection
Experimental: Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA; 18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6	Biological: BG505 MD39.3 gp151 mRNA; Administered by IM injection
Experimental: Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA; 18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6	Biological: BG505 MD39.3 gp151 CD4KO mRNA; Administered by IM injection
Experimental: Part B, Group 1: BG505 MD39.3 mRNA; 18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6	Biological: BG505 MD39.3 mRNA; Administered by IM injection
Experimental: Part B, Group 2: BG505 MD39.3 gp151 mRNA; 18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6	Biological: BG505 MD39.3 gp151 mRNA; Administered by IM injection
Experimental: Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA; 18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6	Biological: BG505 MD39.3 gp151 CD4KO mRNA; Administered by IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Local Solicited Adverse Events 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.	Measured through 7 days after each vaccine dose
Number of Participants Reporting Local Unsolicited Adverse Events 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.	Measured through 7 days after each vaccine dose
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.	Measured through 7 days after each vaccine dose
Chemistry and Hematology Laboratory Measures - ALT in U/L	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population	Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population	Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population	Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population	Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population	Measured during Screening, Days 8, 64, 176 and 225
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils	The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm	Measured during Screening, Days 8, 64, 176 and 225
Number of Participants Reporting Adverse Events (AEs), by Severity Grade	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)	30 days following each injection
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).	30 days following each injection
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)	Measured through Month 12
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)	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)	Measured through Month 12
Number of Participants Reporting Adverse Events of Special Interest (AESIs)	There were no adverse events of special interest reported by any participant.	Measured through Month 12.
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity	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)	Measured through Month 12
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity	There were no early study terminations associated with an AE or reactogenicity reported by any participant.	Measured through Month 12.
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain	Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.	2 weeks after the 3rd vaccination timepoint (M6.5)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain	Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.	2 weeks after the 3rd vaccination timepoint (M6.5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain	Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.	2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain	Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.	2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)	Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument 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. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.	2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)	Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument 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. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.	2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)	Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands	2 weeks after the 3rd vaccination (M6.5)
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)	Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands	2 weeks after the 3rd vaccination (M6.5)

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: National Institutes of Health (NIH); Department of Health and Human Services
• Investigators: Study Chair: Jesse Clark, MD, University of California, Los Angeles; Study Chair: Sharon Riddler, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Riddler SA, Moodie Z, Clark J, Yen C, Allen M, Furch BD, Lu H, Grant S, Mondal K, Anderson M, Maenza J, Lemos MP, Woodward Davis AS, Walsh SR, Sobieszczyk ME, Frank I, Goepfert P, Stephenson KE, Baden LR, Tieu HV, Keefer MC, McElrath MJ, Kublin JG, Corey L. High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302). Ann Intern Med. 2025 Jul;178(7):963-974. doi: 10.7326/ANNALS-24-02701. Epub 2025 Apr 29.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): July 17, 2023
• Study Completion (Estimated): June 24, 2027

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Immune System Diseases; Virus Diseases; Infections; Physiological Effects of Drugs; Sexually Transmitted Diseases, Viral; Immunologic Deficiency Syndromes; Sexually Transmitted Diseases; Immunologic Factors; RNA Virus Infections; Lentivirus Infections; Retroviridae Infections; Communicable Diseases; Blood-Borne Infections
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; HIV Infections; Infections; Communicable Diseases; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Virus Diseases; Immune System Diseases; Retroviridae Infections; Sexually Transmitted Diseases, Viral; RNA Virus Infections; Lentivirus Infections
• Other Study ID Numbers: HVTN 302; DAIDS-ES ID: 38791 (Other Identifier: Division of AIDS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No