CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,900 enrolled
Drug / intervention
Ad26.Mos4.HIV +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03964415
NCT03964415Phase 3Completed
CompareCT.gov

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

Janssen Vaccines & Prevention B.V.·interventional·Posted May 28, 2019·Updated Jul 31, 2024

In Brief

A Phase 3 clinical trial evaluating Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine, and 1 other intervention for Healthy. Completed, enrolled 3,900 participants across 53 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesArgentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 28, 2019
Enrollment StartOct 31, 2019
Primary CompletionAug 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.1 years ago

Interventions

Ad26.Mos4.HIVbiological

Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.

Clade C and Mosaic gp140 HIV bivalent vaccinebiological

Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.

Placebobiological

Participants will receive matching placebo.