drugset / Trial / NCT04985760
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
Phase 1
Completed
32 enrolled
Madhu Chhanda Choudhary
National Institute of Allergy and Infectious Diseases (NIAID) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trimer 4571 | Vaccine | 100 ug | Intramuscular |
| Subject | Trimer 4571 | Vaccine | 500 ug | Intramuscular |
| Background | Aluminum hydroxide | Unknown | 500 ug | Intramuscular |