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NCT05470400 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 6
- Study locations
NCT05470400 is a Phase 1 study of HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 44 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT05470400, a Phase 1 study of HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.
Conditions Studied
Interventions
- BIOLOGICAL FP conjugate vaccine (25 mcg)
- BIOLOGICAL FP conjugate vaccine (200 mcg)
- BIOLOGICAL Trimer 6931 (100 mcg)
- BIOLOGICAL Trimer 6931 (200 mcg)
- BIOLOGICAL Trimer 4571 (200 mcg)
Study Locations (6)
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
Georgia
- Atlanta - Hope Clinic - Atlanta
Massachusetts
- BIDMC Vcrs [32077] - Boston
Pennsylvania
- University of Pittsburgh CRS [1001] - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2024-01-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05470400
The ClinicalTrials.gov registry entry for NCT05470400 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions - of which FP conjugate vaccine (25 mcg) is the first listed.
NCT05470400 reports 6 study locations spanning 4 distinct geographic areas - top geographies include New York, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05470400 about?
NCT05470400 is a clinical study titled "A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults". This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and wel...
What is the current status of trial NCT05470400?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2022-08-15. Estimated completion is 2024-01-24.
What conditions does trial NCT05470400 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT05470400?
The interventions under investigation include: FP conjugate vaccine (25 mcg) (BIOLOGICAL), FP conjugate vaccine (200 mcg) (BIOLOGICAL), Trimer 6931 (100 mcg) (BIOLOGICAL), Trimer 6931 (200 mcg) (BIOLOGICAL), Trimer 4571 (200 mcg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05470400?
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 NCT05470400 being conducted?
This trial has 6 study locations across Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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