A Phase 1 Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
The clinical schedule will consist of 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24.40 volunteers without HIV and in overall good health, aged 18 to 60 years, who previously participated in the HVTN 706 trial.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Formerly participated in HVTN 706 study as active vaccine arm or placebo recipient (those enrolled in the active vaccine arm of HVTN 706 must have received all 4 vaccinations according to the HVTN 706 protocol). 2. Demonstrates an understanding of the study and is able and willing to complete the informed consent process. 3. 18 to ≤ 60 years old, on day of enrollment. 4. Available for clinic follow-up through the last clinic visit, willing to undergo FNA, and willing to be contacted 12 months after the last study-product administration. 5. Agrees not to enroll in anothe…
Interventions
- BiologicalCD40.HIVRI.Env (VRIPRO)
To be administered subcutaneously as 1 mg admixed with Hiltonol, Poly-ICLC as a single dose.
- BiologicalHiltonol Poly-ICLC-adjuvant
Vaccine adjuvant
Locations (7)
- Bridge HIV CRSSan Francisco, California
- The Hope Clinic of the Emory Vaccine Center CRSDecatur, Georgia
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS)Boston, Massachusetts
- Columbia P&S CRSNew York, New York
- Penn Prevention CRS (Site ID# 30310)Philadelphia, Pennsylvania
- Vanderbilt Vaccine (VV) CRSNashville, Tennessee