A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of DV201P-RNA and DV202B1-RNA, immunogens designed to induce HIV-1 envelope (Env) V2 apex-specific broadly neutralizing antibodies (V2 apex bnAbs). Both vaccines consist of a modified mRNA encapsulated in lipid nanoparticles (LNP) that when translated in cells produces HIV-1 Env gp150 transmembrane trimers. The trial will enroll adult volunteers without HIV and in overall good health.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Demonstrates an understanding of the study and is able and willing to complete the informed consent process. 2. At least 18 years old at screening and up to 55 years old on day of enrollment. 3. Available for clinic follow-up through the last clinic visit. 4. Willing to undergo study procedures as outlined in the schedule of procedures (Appendix A). 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…
Interventions
- BiologicalDV201P-RNA
To be administered intramuscularly as a split dose.
- BiologicalDV202B1-RNA
To be administered intramuscularly as a split dose.
Locations (7)
- The Ponce de Leon Center CRSAtlanta, Georgia
- The Hope Clinic of the Emory Vaccine Research Center; Emory UniversityDecatur, Georgia
- Beth Israel Deaconess Medical Center VCRS (BIDMC VCRS Site # 32077)Boston, Massachusetts
- Columbia P&S CRSNew York, New York
- University of Rochester Vaccines to Prevent HIV Infection CRSRochester, New York
- Penn Prevention CRSPhiladelphia, Pennsylvania