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Completed Phase 3 Interventional Accepts healthy volunteers Results available

A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals

ClinicalTrials.gov ID: NCT03964415

Public ClinicalTrials.gov record NCT03964415. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 12, 2026, 7:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals

Study identification

NCT ID
NCT03964415
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Vaccines & Prevention B.V.
Industry
Enrollment
3,900 participants

Conditions and interventions

Conditions

Interventions

  • Ad26.Mos4.HIV Biological
  • Clade C and Mosaic gp140 HIV bivalent vaccine Biological
  • Placebo Biological

Biological

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 30, 2019
Primary completion
Aug 9, 2023
Completion
Aug 9, 2023
Last update posted
Jul 30, 2024

2019 – 2023

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35222
Bridge HIV San Francisco California 94102
Whitman Walker Health Washington D.C. District of Columbia 20816
University of Miami Miami Florida 33136
Orlando Immunology Center Orlando Florida 32803
Emory University Rollins School of Public Health - Ponce De Leon CRS Atlanta Georgia 30322
The Hope Clinic at Emory University Decatur Georgia 30030
University Of Illinois Chicago Illinois 60612
New Orleans Adolescent Trials Unit CRS New Orleans Louisiana 70112
Dana-Farber/Brigham and Women's Hospital Boston Massachusetts 02115
Fenway Health Boston Massachusetts 02215
Rutgers, The State University of New Jersey - The University Hospital/ACTG Network Newark New Jersey 07103
Harlem Prevention Center CRS New York New York 10027
Columbia University Medical Center New York New York 10032
New York Blood Center New York New York 10065
Strong Memorial Infectious Disease Rochester New York 14642
University of Pennsylvania Philadelphia Pennsylvania 19104
Vanderbilt University Medical Center Nashville Tennessee 37212
Gordon E. Crofoot MD Houston Texas 77098
Seattle Vaccine Trials Unit Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03964415, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2024 · Synced May 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03964415 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →