drugset / Trial / NCT06694753
Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.
Phase 1
Active not recruiting
96 enrolled
International AIDS Vaccine Initiative
Bill and Melinda Gates Foundation · collabModernaTX, Inc. · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabThe Scripps Research Institute · collab
RandomizedSequentialQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immunogenicity of mRNAs encoding HIV immunogens (eOD-GT8 60mer, core-g28v2 60mer, N332-GT5 gp151) in adult participants without HIV and in overall good health in South Africa.
Timeline
- Start
- 2025-12-15
- Primary completion
- 2026-12-08
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1645-CoreG28v2 | Messenger RNA (mRNA) | 10 ug | Intramuscular |
| Subject | mRNA-1645-CoreG28v2 | Messenger RNA (mRNA) | 30 ug | Intramuscular |
| Subject | mRNA-1645-N332GT5 | Messenger RNA (mRNA) | 10 ug | Intramuscular |
| Subject | mRNA-1645-N332GT5 | Messenger RNA (mRNA) | 30 ug | Intramuscular |
| Subject | mRNA-1645-eODGT8 | Messenger RNA (mRNA) | 10 ug | Intramuscular |
| Subject | mRNA-1645-eODGT8 | Messenger RNA (mRNA) | 30 ug | Intramuscular |