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NCT05471076 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV
A Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 6
- Study locations
NCT05471076: Active Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05471076 is a Phase 1 study of HIV-1-infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05471076, a Phase 1 study of HIV-1-infection, 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
- 52 participants
- Enrollment target
- 6
- Study locations
Study Summary
The clinical study is designed to evaluate the ability of two priming vaccine regimens to activate and induce the maturation of cross-reactive CD4 binding site (CD4-bs) antibodies, including VRC01-class antibodies. VRC01- class antibodies are highly desirable to elicit via vaccination because they have broad cover all clades of HIV and passive administration of VRC01 monoclonal antibodies has been demonstrated to prevent acquisition of susceptible HIV strains in clinical trials. The study will assess whether B cells expressing VRC01-like B cell receptors proliferate following immunization with a 'germline-targeting' recombinant Env immunogen. The study will also test whether an immunization strategy based upon fractionated dose delivery of the immunogen may improve the maturation of VRC01-class B cells when compared to traditional bolus dosing. In addition, the study will test whether alterations in the dose of the subsequent boost immunizations affects VRC01-class B cell activation and the rate of antibody affinity maturation. The primary hypothesis of the optional boost regimen is that BG505 SOSIP.GT1.1 gp140 adjuvated with 3M-052-AF + Alum is safe and well-tolerated and will further mature B-cell lineages elicited by 426c.Mod.Core-C4b priming regimens.
Primary Outcome
Assessed by clinic staff. For a given sign or symptom, each subject's reactogenicity will be counted once under the maximum severity for each injection/ vaccination.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL 426c.Mod.Core-C4b 30 mcg
- BIOLOGICAL 426c.Mod.Core-C4b 100 mcg
- BIOLOGICAL 426c.Mod.Core-C4b 300 mcg
- BIOLOGICAL BG505
Study Locations (6)
Alabama
- Alabama CRS - Birmingham
California
- Bridge HIV CRS - San Francisco
Georgia
- The Ponce de Leon Center CRS - Atlanta
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
New York
- Columbia P&S CRS - New York
Washington
- Seattle Vaccine and Prevention CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-08-22 |
| Est. Completion | 2026-05-21 |
| Phase | Phase 1 |
What the registry record for NCT05471076 still lists
NCT05471076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT05471076 lists 6 locations in 6 states (Alabama, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT05471076 about?
NCT05471076 is a clinical study titled "Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV". The clinical study is designed to evaluate the ability of two priming vaccine regimens to activate and induce the maturation of cross-reactive CD4 binding site (CD4-bs) antibodies, including VRC01-class antibodies. VRC01- class antibodies are highly desirable to elicit via vaccination because they h...
What is the current status of trial NCT05471076?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2022-08-22. Estimated completion is 2026-05-21.
What conditions does trial NCT05471076 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05471076?
The interventions under investigation include: Placebo (OTHER), 426c.Mod.Core-C4b 30 mcg (BIOLOGICAL), 426c.Mod.Core-C4b 100 mcg (BIOLOGICAL), 426c.Mod.Core-C4b 300 mcg (BIOLOGICAL), BG505 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05471076?
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 NCT05471076 being conducted?
This trial has 6 study locations across Alabama, California, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05471076's enrollment target sits among peer trials
52 49th of 71 higher than 23 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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