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NCT05217641 · ClinicalTrials.gov registry record · Phase 1
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 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
- 10
- Study locations
NCT05217641: Active Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05217641 is a Phase 1 study of HIV Infections that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 108 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (76% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05217641, a Phase 1 study of HIV Infections, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL BG505 MD39.3 mRNA
- BIOLOGICAL BG505 MD39.3 gp151 mRNA
- BIOLOGICAL BG505 MD39.3 gp151 CD4KO mRNA
Study Locations (10)
New York
- New York Blood Center CRS [31801] - New York
- Columbia P&S CRS [30329] - New York
- University of Rochester Vaccines to Prevent HIV Infection CRS [31467] - Rochester
Massachusetts
- Bidmc Vcrs [32077] - Boston
- Brigham and Women's Hospital Vaccine CRS [30007] - Boston
Pennsylvania
- Penn Prevention CRS [30310] - Philadelphia
- University of Pittsburgh CRS [1001] - Pittsburgh
Alabama
- Alabama CRS [31788] - Birmingham
California
- UCLA Vine Street Clinic CRS [31607] - Los Angeles
Washington
- Seattle Vaccine and Prevention CRS [30331] - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2022-02-11 |
| Est. Completion | 2027-06-24 |
| Phase | Phase 1 |
What the registry record for NCT05217641 still lists
NCT05217641 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (76% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which BG505 MD39.3 mRNA is the first listed.
NCT05217641 lists 10 locations in 6 states (New York, Massachusetts, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05217641 about?
NCT05217641 is a clinical study titled "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". 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 primar...
What is the current status of trial NCT05217641?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2022-02-11. Estimated completion is 2027-06-24.
What conditions does trial NCT05217641 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT05217641?
The interventions under investigation include: BG505 MD39.3 mRNA (BIOLOGICAL), BG505 MD39.3 gp151 mRNA (BIOLOGICAL), BG505 MD39.3 gp151 CD4KO mRNA (BIOLOGICAL).
Who is sponsoring clinical trial NCT05217641?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05217641 being conducted?
This trial has 10 study locations across Alabama, California, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05217641's enrollment target sits among peer trials
108 255th of 542 higher than 288 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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