RecruitingPhase 1NCT06665646

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


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

40 participants

Start Date

Sep 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental HIV vaccine booster regimen — combining a vaccine component (CD40.HIVRI.Env, also called VRIPRO) with an immune-boosting adjuvant (Hiltonol / Poly-ICLC) — in adults who previously participated in the HVTN 706 HIV vaccine trial, to see if an additional dose or series can strengthen or renew immune responses against HIV. **You may be eligible if...** - You previously participated in the HVTN 706 study (either as a vaccine or placebo recipient; vaccine recipients must have completed all 4 vaccinations) - You are between 18 and 60 years old - You are in good general health - You agree to HIV prevention counseling throughout the study - Your blood count (hemoglobin) meets the minimum required level **You may NOT be eligible if...** - You did not participate in HVTN 706 - You are enrolled in another study of an investigational drug (unless approved by both studies) - You have health conditions that would interfere with safety monitoring - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 CRS

San Francisco, California, United States

The Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia, United States

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, United States

Columbia P&S CRS

New York, New York, United States

Penn Prevention CRS (Site ID# 30310)

Philadelphia, Pennsylvania, United States

Vanderbilt Vaccine (VV) CRS

Nashville, Tennessee, United States

Seattle Vaccine and Prevention CRS

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06665646


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