Actively Recruiting
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-14
40
Participants Needed
7
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously participated in the HVTN 706 study as an active vaccine or placebo recipient; if in the active vaccine arm, must have received all 4 vaccinations
- Able and willing to complete the informed consent process
- Aged 18 to 60 years at enrollment
- Available for clinic follow-up through the last visit and willing to undergo fine needle aspirate (FNA)
- Willing to be contacted 12 months after last study-product administration
- Agree not to enroll in another investigational study during this trial unless approved
- In good general health as judged by the investigator
- Physical exam and lab results without significant findings affecting safety or reactogenicity
- Agree to discuss HIV acquisition risk and prevention counseling
- Hemoglobin ≥11.0 g/dL for women and ≥13.0 g/dL for men; adjusted for hormone use
- White blood cell count between 2,500 and 12,000/mm³ (exceptions allowed with approval)
- Platelet count between 125,000 and 550,000/mm³
- Alanine aminotransferase (ALT) less than 2.5 times upper institutional limit
- Serum creatinine ≤1.1 times upper limit of normal
- Systolic blood pressure 90 to <140 mmHg and diastolic 50 to <90 mmHg
- Negative HIV test within 14 days prior to enrollment
- Negative for Hepatitis C antibodies or nucleic acid test if antibodies detected
- Negative for Hepatitis B surface antigen
- Women with pregnancy potential must have a negative pregnancy test on enrollment day and agree to use effective contraception from 21 days before enrollment until 8 weeks after last vaccination
- Women who had hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or menopause are exempt from pregnancy testing
- Female volunteers agree not to pursue pregnancy through assisted methods during the study period
You will not qualify if you...
- Body mass index (BMI) ≥40 unless approved by safety review
- Diabetes mellitus requiring medication except well-controlled Type 2 diabetes or isolated gestational diabetes
- Previous or current receipt of investigational HIV vaccine other than HVTN 706 vaccine regimen
- Receipt of non-HIV investigational vaccines within the past year unless licensed or authorized
- Immunodeficiency or use of medications impairing immune response such as high-dose glucocorticoids
- Blood products or immunoglobulin within 16 weeks prior to enrollment unless approved
- Any vaccine received within 4 weeks prior to enrollment
- Initiation of allergy immunotherapy within past year unless approved
- Use of investigational agents with short half-life within 4 weeks or longer half-life within past year unless approved
- Use of injectable long-acting Cabotegravir within 18 months prior to enrollment
- Serious adverse reactions to any vaccine including anaphylaxis
- Hereditary, acquired, or idiopathic angioedema
- Idiopathic urticaria within past year
- Bleeding disorders contraindicating study procedures
- Seizures or seizure medications within past 3 years
- Asplenia or functional asplenia
- Active duty or reserve US military personnel
- Other chronic or significant conditions jeopardizing safety or rights including substance use, psychiatric disorders, recent suicide attempts, or cancer with recurrence risk
- Asthma with severe exacerbations or high medication use within past year unless approved
- History of potential immune-mediated medical conditions except remote Bell's palsy or mild skin conditions
- Allergy to local anesthetics like Novocaine or Lidocaine
- Pregnant or breastfeeding
- Difficulty with venous access as judged clinically
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Bridge HIV CRS
San Francisco, California, United States, 94102
Actively Recruiting
2
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States, 30030
Withdrawn
3
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States, 02115-6110
Actively Recruiting
4
Columbia P&S CRS
New York, New York, United States, 10032
Withdrawn
5
Penn Prevention CRS (Site ID# 30310)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States, 98104
Withdrawn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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