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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06665646•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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

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.
•6. In good general health according to the clinical judgment of the site investigator.
•7. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
•8. Agrees to discuss the potential for HIV acquisition and agrees to prevention counseling.
•9. Hemoglobin (Hgb):
•* ≥11.0 g/dL for women
•* ≥13.0 g/dL for men
+45 more criteria

Exclusion Criteria

•1. Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.
•2. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered by the PSRT on a case-by-case basis, provided that the HgbA1c is ≤ 8% within the last 6 months (sites may draw these at screening).

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

Key Dates

Start Date

September 14, 2025

Primary Completion Date

July 27, 2026

Completion Date

May 4, 2027

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

HIV Infections

Interventions

CD40.HIVRI.Env (VRIPRO)

BIOLOGICAL

Hiltonol Poly-ICLC-adjuvant

BIOLOGICAL

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NCT06694805

HIV Infections

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RECRUITING

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NCT04142047

HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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