drugset / Trial / NCT06919016
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV
Phase 1
Active not recruiting
45 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Department of Health and Human Services · collabNational Institutes of Health (NIH) · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Timeline
- Start
- 2025-08-06
- Primary completion
- 2027-03-25
- Completion
- 2027-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DV700P-RNA | Vaccine | 50 ug | Intramuscular |
| Subject | DV700P-RNA | Vaccine | 100 ug | Intramuscular |
| Subject | DV700P-RNA | Vaccine | 150 ug | Intramuscular |
| Subject | DV701B1.1-RNA | Vaccine | 50 ug | Intramuscular |
| Subject | DV701B1.1-RNA | Vaccine | 100 ug | Intramuscular |
| Subject | DV701B1.1-RNA | Vaccine | 150 ug | Intramuscular |