Clinical trialNCT05470400TerminatedPhase 1Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment44HIV

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Michael Keefer, M.D.
Univ. of Rochester Med. Ctr., HVTU
Study Chair
clinicaltrials.gov ↗
Troy Martin
HVTN LOC, Fred Hutch
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Atlanta - Hope Clinic
Atlanta, Georgia, United States
Bidmc Vcrs [32077]
Boston, Massachusetts, United States
Columbia P&s Crs [30329]
New York, New York, United States
New York Blood Center Crs [31801]
New York, New York, United States
University of Rochester Vaccines To Prevent Hiv Infection Crs [31467]
Rochester, New York, United States
University of Pittsburgh Crs [1001]
Pittsburgh, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

FP conjugate vaccineTrimer 4571Trimer 6931

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Aug 2022
Primary completion: 24 Jan 2024
Completion: 24 Jan 2024
Last update posted: 23 Apr 2026
Registered enrollment: 44
Registry id: NCT05470400

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.