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NCT04224701 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
A Phase 1 study of HIV Infections, sponsored by International AIDS Vaccine Initiative.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 3
- Study locations
NCT04224701: Completed Phase 1 study of HIV Infections, sponsored by International AIDS Vaccine Initiative.
NCT04224701 is a Phase 1 study of HIV Infections that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 48 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04224701, a Phase 1 study of HIV Infections, has completed, sponsored by International AIDS Vaccine Initiative.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.
Primary Outcome
Proportion of volunteers with Grade 2 or greater reactogenicity (i.e., solicited adverse events) from Day 0 through Day 7 after each investigational product (IP) administration
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted
Study Locations (3)
District of Columbia
- George Washington University - Washington D.C.
New York
- Rockefeller University - New York
Other
- The Amsterdam University Medical Centers - Amsterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2023-08-02 |
| Phase | Phase 1 |
What the finished NCT04224701 record still lists
NCT04224701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04224701 reports a single indexed study location in District of Columbia, New York, Other.
Frequently Asked Questions
What is clinical trial NCT04224701 about?
NCT04224701 is a clinical study titled "A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults". This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.
What is the current status of trial NCT04224701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-08-01. Estimated completion is 2023-08-02.
What conditions does trial NCT04224701 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04224701?
The interventions under investigation include: Placebo (BIOLOGICAL), BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted (BIOLOGICAL).
Who is sponsoring clinical trial NCT04224701?
This trial is sponsored by International AIDS Vaccine Initiative, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04224701 being conducted?
This trial has 3 study locations across District of Columbia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04224701's enrollment target sits among peer trials
48 367th of 542 higher than 168 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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