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
Public ClinicalTrials.gov record NCT05217641. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05217641
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Interventions
- BG505 MD39.3 mRNA Biological
- BG505 MD39.3 gp151 mRNA Biological
- BG505 MD39.3 gp151 CD4KO mRNA Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 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
- Feb 11, 2022 (Actual)
- Primary completion
- Jul 17, 2023 (Actual)
- Completion
- Jun 24, 2027 (Estimated)
- Last update posted
- Oct 14, 2025
2022 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama CRS [31788] | Birmingham | Alabama | 35222 | — |
| UCLA Vine Street Clinic CRS [31607] | Los Angeles | California | 90038 | — |
| Bidmc Vcrs [32077] | Boston | Massachusetts | 02115 | — |
| Brigham and Women's Hospital Vaccine CRS [30007] | Boston | Massachusetts | 02115 | — |
| New York Blood Center CRS [31801] | New York | New York | 10065 | — |
| Columbia P&S CRS [30329] | New York | New York | 30329 | — |
| University of Rochester Vaccines to Prevent HIV Infection CRS [31467] | Rochester | New York | 14642 | — |
| Penn Prevention CRS [30310] | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh CRS [1001] | Pittsburgh | Pennsylvania | 15213 | — |
| Seattle Vaccine and Prevention CRS [30331] | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05217641, 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 Oct 14, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05217641 live on ClinicalTrials.gov.