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

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06665646
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 14, 2025
Status verified
Jun 2026
Primary completion
Jul 27, 2026
Completion
May 4, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1- Study product received in HVTN 706: Study Vaccine
    Participants will receive Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env(VRIPRO) as a subcutaneous injection.
  • Experimental: Group 2 - Study product received in HVTN 706: Placebo
    Participants will receive Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env(VRIPRO) as a subcutaneous injection.

Primary Outcome Measure

Local signs and symptoms will be collected for a minimum of 14 days following receipt of adjuvanted CD40.HIVRI.Env (VRIPRO) [ Time Frame: For a minimum of 14 days following receipt of adjuvanted CD40.HIVRI.Env (VRIPRO) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Bridge HIV CRSSan FranciscoCalifornia94102
Emily Schaeffer, BA
[email protected]
415-214-1085
The Hope Clinic of the Emory Vaccine Center CRSDecaturGeorgia30030-
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)BostonMassachusetts02115-6110
Jose Licona, MD
[email protected]
617-525-9433
Columbia P&S CRSNew YorkNew York10032-
Penn Prevention CRS (Site ID# 30310)PhiladelphiaPennsylvania19104
Debora Dunbar, MSN, CRNP
[email protected]
215-746-3713
Vanderbilt Vaccine (VV) CRSNashvilleTennessee37232
Shonda Sumner, BSN
[email protected]
615-343-6906
Seattle Vaccine and Prevention CRSSeattleWashington98104-

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
Bridge HIV CRS· San Francisco, CAThe Hope Clinic of the Emory Vaccine Center CRS· Decatur, GABrigham and Women's Hospital Vaccine CRS (BWH VCRS)· Boston, MAColumbia P&S CRS· New York, NYPenn Prevention CRS· Philadelphia, PAVanderbilt Vaccine (VV) CRS· Nashville, TN

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