drugset / Trial / NCT06613789
Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected
Phase 1
Not yet recruiting
22 enrolled
HIV Vaccine Trials Network
Access to Advanced Health Institute · collabFred Hutchinson Cancer Center · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immunogenicity of 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum in infants with perinatal HIV exposure who are without HIV at birth
Timeline
- Start
- 2026-07-13
- Primary completion
- 2027-06-03
- Completion
- 2027-06-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3M-052-AF | Small molecule | 0.3 ug | Intramuscular |
| Subject | 3M-052-AF | Small molecule | 0.75 ug | Intramuscular |
| Subject | 3M-052-AF | Small molecule | 1.5 ug | Intramuscular |
| Subject | 426c.Mod.Core-C4b | Protein / enzyme biologic | 20 ug | Intramuscular |
| Background | Aluminum hydroxide | Unknown | 250 ug | Intramuscular |