drugset / Trial / NCT06332339
Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.
Phase 1
Active not recruiting
45 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
RandomizedParallel-groupOpen-labelPrevention
Summary
The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question\[s\] it aims to answer are: * Are these vaccine regimens safe and well tolerated? * Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.
Timeline
- Start
- 2024-03-15
- Primary completion
- 2026-11-11
- Completion
- 2026-11-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 16055 NFL delta Gly4 trimer | Protein / enzyme biologic | 200 ug | Intramuscular |
| Subject | Ad4-Env145NFL | Vaccine | 5e+08 unknown | Intranasal |
| Subject | Trimer 4571 | Vaccine | 100 ug | Intramuscular |