drugset / Trial / NCT05470400
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults
Phase 1
Terminated
44 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Department of Health and Human Services · collabNational Institutes of Health (NIH) · collab
RandomizedSequentialOpen-labelPrevention
Summary
This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.
Timeline
- Start
- 2022-08-15
- Primary completion
- 2024-01-24
- Completion
- 2024-01-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FP conjugate vaccine | Unknown | 25 ug | Intramuscular |
| Subject | FP conjugate vaccine | Unknown | 200 ug | Intramuscular |
| Subject | Trimer 4571 | Vaccine | 100 ug | Intramuscular |
| Subject | Trimer 4571 | Vaccine | 200 ug | Intramuscular |
| Subject | Trimer 6931 | Unknown | 100 ug | Intramuscular |
| Subject | Trimer 6931 | Unknown | 200 ug | Intramuscular |