What is Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) studying for HIV infections?

Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) is being studied to evaluate its safety and the immune response it triggers in adults previously involved in the HVTN 706 trial. This research aims to better understand how the vaccine interacts with the immune system to support HIV prevention efforts. The study is sponsored by the National Institute of Allergy and Infectious Diseases.

Who may be eligible for this HIV infections clinical trial?

Adults aged 18 to 60 years who previously participated in the HVTN 706 trial as a vaccine or placebo recipient may be eligible. Participants must be generally healthy, not pregnant or breastfeeding, and willing to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV infections clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 1

Age: 18Years - 60Years

All Genders

Healthy Volunteers

ID06665646

Phase 1 Study of Hiltonol Poly-ICLC-adjuvanted CD40.HIVRI.Env VRIPRO Vaccine in Adults Previously in HVTN 706 Evaluating Safety and Immune Response with Subcutaneous Injections

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-05

Participants Needed

Research Sites

40 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and immune response of a vaccine called Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env VRIPRO in adults aged 18 to 60 years who previously participated in the HVTN 706 trial and are currently without HIV and in good health. This Phase 1 clinical trial aims to better understand the vaccines effects in this specific group and is sponsored by the National Institute of Allergy and Infectious Diseases NIAID. Participants will receive three subcutaneous injections of the vaccine at weeks 0, 4, and 24. The vaccine includes the CD40.HIVRI.Env VRIPRO biological agent combined with Hiltonol Poly-ICLC as an adjuvant to enhance the immune response. The study is open-label and non-randomized, with all participants receiving the investigational vaccine. During the study, researchers will monitor local and systemic reactions for at least 14 days after each vaccination. They will also track any serious or adverse events for up to one year after the last dose. Blood samples will be collected to measure various immune responses, including specific antibody levels and T-cell activity, at multiple time points. Participants will be followed closely through clinic visits and contacted 12 months after the final vaccination to assess long-term safety and immune response.

CONDITIONS

Brief 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

Age: 18Years - 60Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Previously participated in the HVTN 706 study as an active vaccine or placebo recipient
Understands the study and can complete informed consent
Aged between 18 and 60 years on enrollment day
Available for clinic follow-up and willing to undergo fine needle aspiration and 12-month contact after last vaccination
Agrees not to join another investigational study during this trial without approval
In good general health as judged by the investigator
No significant clinical findings in physical exam or labs that affect safety
Agrees to HIV prevention counseling
Hemoglobin level at least 11.0 g/dL for women and 13.0 g/dL for men, adjusted if on certain hormone treatments
White blood cell count between 2,500 and 12,000/mm3 (higher counts may be acceptable with approval)
Platelet count between 125,000 and 550,000/mm3
Alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal
Serum creatinine within normal institutional limits
Blood pressure between 90/50 and less than 140/90 mmHg
Negative HIV test result within 14 days before enrollment
Negative for Hepatitis C antibodies or nucleic acid if antibodies detected
Negative for Hepatitis B surface antigen
Women with pregnancy potential must have a negative pregnancy test 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 must agree not to seek pregnancy through assisted reproductive methods before and during the study

You will not qualify if you...

Body mass index (BMI) of 40 or higher unless approved
Diabetes mellitus, except well-controlled type 2 diabetes with specific criteria
Previous or current receipt of investigational HIV vaccines other than HVTN 706 vaccine recipients
Receipt of non-HIV investigational vaccines within the past year unless authorized
Congenital or acquired immune deficiency or immune-impairing medications
Blood products or immunoglobulin within 16 weeks prior unless approved
Any vaccine within 4 weeks prior to enrollment
Recent initiation of allergy immunotherapy unless stable or approved
Use of investigational agents with short half-lives within 4 weeks or longer half-lives within 1 year without approval
Use of injectable long-acting Cabotegravir within 18 months
Serious adverse vaccine reactions such as anaphylaxis
Hereditary or acquired angioedema or idiopathic urticaria within the past year
Bleeding disorders contraindicating study procedures
Seizures or seizure medications within the past 3 years
Asplenia or functional asplenia
Active duty or reserve US military personnel
Other significant health conditions that may risk safety or rights
Specific asthma conditions including recent corticosteroid use or high-dose inhaled steroids
History of potential immune-mediated medical conditions except certain mild or remote cases
Allergy to local anesthetics like Novocaine or Lidocaine
Pregnancy or breastfeeding
Difficulty with venous access based on medical history or examination

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Phase 1 Study of Hiltonol Poly-ICLC-adjuvanted CD40.HIVRI.Env VRIPRO Vaccine in Adults Previously in HVTN 706 Evaluating Safety and Immune Response with Subcutaneous Injections

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria