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Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy

NCT04985760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-22

No results posted yet for this study

Summary

Trimer 4571 is a vaccine designed to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV. Trimer 4571 is investigational, meaning it is not approved by the US Food and Drug Administration (FDA). There is limited human experience with the Trimer 4571 vaccine administered with aluminum hydroxide (alum) and the vaccine has not been tested in people with HIV prior to this study although it has been tested in healthy volunteers. The goal of this study is to see if Trimer 4571 is safe and well tolerated and to see if it will help the immune system produce bnAbs against HIV.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant

Investigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent

BIOLOGICAL

Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant

Volume matched control for Trimer 4571 vaccine 100mcg

BIOLOGICAL

Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant

Investigational vaccine composed of Trimer 4571 500mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent

BIOLOGICAL

Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant

Volume matched control for Trimer 4571 vaccine 500mcg

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Madhu Chhanda Choudhary

    lead OTHER

Principal Investigators

  • Madhu Choudhary, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2026-01-16
Completion
2026-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985760 on ClinicalTrials.gov