NCT06665646

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	CD40.HIVRI.Env (VRIPRO)	To be administered subcutaneously as 1 mg admixed with Hiltonol, Poly-ICLC as a single dose.
BIOLOGICAL	Hiltonol Poly-ICLC-adjuvant	Vaccine adjuvant

Timeline

• Start date: 2025-09-14
• Primary completion: 2026-07-27
• Completion: 2027-05-04
• First posted: 2024-10-30
• Last updated: 2026-04-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study