drugset / Trial / NCT04985760

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

NCT04985760

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2021-09-30
Primary completion
2026-01-16
Completion
2026-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Trimer 4571 Vaccine 100 ug Intramuscular
Subject Trimer 4571 Vaccine 500 ug Intramuscular
Background Aluminum hydroxide Unknown 500 ug Intramuscular