drugset / Trial / NCT06267872
A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum
Phase 1
Withdrawn
National Institute of Allergy and Infectious Diseases (NIAID)
Access to Advanced Health Institute (AAHI) · collabDepartment of Health and Human Services · collabDuke University · collabNational Institutes of Health (NIH) · collab
RandomizedSequentialOpen-labelPrevention
Summary
This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.
Timeline
- Start
- 2024-10-07
- Primary completion
- 2025-12-30
- Completion
- 2026-09-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3M-052-AF | Small molecule | 3 ug | Intramuscular |
| Subject | 3M-052-AF | Small molecule | 5 ug | Intramuscular |
| Subject | ACU-026-001-1 | Unknown | 1 mg | Intramuscular |
| Subject | ACU-026-001-1 | Unknown | 2 mg | Intramuscular |
| Subject | Aluminum Hydroxide Suspension | Unknown | 500 ug | Intramuscular |
| Subject | CD4BS CH505M5 Pr-NP1 | Unknown | 60 ug | Intramuscular |
| Subject | CD4BS CH505M5 Pr-NP1 | Unknown | 100 ug | Intramuscular |
| Subject | CH505 TF chTrimer | Vaccine | 300 ug | Intramuscular |