drugset / Trial / NCT03699241
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults
Phase 1
Completed
61 enrolled
International AIDS Vaccine Initiative
Fred Hutchinson Cancer Research Center - Seattle HIV Vaccine Trials Unit · collabGlaxoSmithKline · collabKenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR) · collabMassachusetts General Hospital · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.
Timeline
- Start
- 2018-12-03
- Primary completion
- 2023-03-21
- Completion
- 2023-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BG505 SOSIP.664 gp140 | Vaccine | 30 ug | Intramuscular |
| Comparator | BG505 SOSIP.664 gp140 | Vaccine | 100 ug | Intramuscular |
| Comparator | BG505 SOSIP.664 gp140 | Vaccine | 300 ug | Intramuscular |