CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 108 enrolled
Drug / intervention
BG505 MD39.3 mRNA +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/NCT05217641
NCT05217641Phase 1Active
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 1, 2022·Updated Oct 14, 2025

In Brief

A Phase 1 clinical trial evaluating BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, and 1 other intervention for HIV Infections. Active but no longer recruiting, targeting 108 participants across 10 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Department of Health and Human Services

Timeline

Phase 1Active
202220232024202520262027
First PostedFeb 1, 2022
Enrollment StartFeb 11, 2022
Primary CompletionJul 17, 2023
Study CompletionJun 24, 2027
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.4 years ago

Interventions

BG505 MD39.3 mRNAbiological

Administered by IM injection

BG505 MD39.3 gp151 mRNAbiological

Administered by IM injection

BG505 MD39.3 gp151 CD4KO mRNAbiological

Administered by IM injection