Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participan
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.
| Condition(s) | HIV Infections |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Demonstrates an understanding of the study and is able and willing to complete the informed consent process. 2. 18 to ≤ 55 years old, on day of enrollment. 3. Available for clinic follow-up through the last clinic visit. 4. Willingness to undergo FNA and leukapheresis. 5. Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial Sponsor and the IAVI Medical Monitor are required prior to enrollment into DESIIGN001/IAVI G004. 6. In good general health according to the clinical judgment of the Investigator. 7. Physical examination and laboratory results without clinically significant findings that would interfere with assess |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | International AIDS Vaccine Initiative |
| Locations | Soshanguve, Gauteng, South Africa; Soweto, Gauteng, South Africa; Durban, KwaZulu-Natal, South Africa; Isipingo, KwaZulu-Natal, South Africa; Cape Town, Western Cape, South Africa; Cape Town, Western Cape, South Africa |
| Start date | 2025-12-15 |
| NCT ID | NCT06694753 |
| Official listing | https://clinicaltrials.gov/study/NCT06694753 |