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Active Not Recruiting NCT06694753

Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.

Conditions: HIV Infections

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 96
Sponsor: International AIDS Vaccine Initiative

Location: Setshaba Research Centre CRS Soshanguve Gauteng

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.

Eligibility Criteria

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 assessment of safety or reactogenicity in the clinical judgment of the Investigator. 8. Assessed by clinical staff as having a low likelihood of acquiring HIV per guidelines (see Appendix 4), agrees to discuss their potential for HIV acquisition, agrees to prevention counseling, and agrees to avoid behaviors associated with a higher likelihood of acquiring HIV through the final study visit. "Low likelihood" may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed in Appendix 4. 9. Hemoglobin (Hgb): * ≥12.0 g/dL for AFAB volunteers * ≥13.0 g/dL for cisgender AMAB volunteers or for volunteers who have been on masculinizing hormone therapy for more than 6 consecutive months * ≥12.0 g/dL for AMAB volunteers who have been on feminizing hormone therapy for more than 6 consecutive months * For volunteers who have been on gender-affirming hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth. 10. White blood cell (WBC) count = 2,500 to 12,000/mm3. 11. Platelets = 125,000 to 550,000/mm3. 12. Alanine aminotransferase (ALT) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06694753). StuddyBuddy aggregates publicly available trial information.