drugset / Trial / NCT04983030
Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults
Phase 1/2
Completed
28 enrolled
Boris Juelg, MD PhD
Harvard School of Public Health (HSPH) · collabJanssen Pharmaceuticals · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
Timeline
- Start
- 2022-04-01
- Primary completion
- 2026-02-23
- Completion
- 2026-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.Mos4.HIV | Vaccine | — | — |
| Subject | MVA-BN-HIV | Vaccine | — | — |
| Subject | PGDM1400 | Monoclonal antibody | — | — |
| Subject | PGT121 | Monoclonal antibody | — | — |
| Subject | VRC07-523LS | Monoclonal antibody | — | — |