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.
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).
Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
18 to ≤ 60 years old, on day of enrollment.
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.
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.
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).
Previous or current recipient of an investigational HIV vaccine (not applicable to previous placebo/control recipients), with the exception of the HVTN 706 vaccine regimen as per Inclusion Criteria #1.
Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.
Single group
CD40.HIVRI.Env (VRIPRO)
Biological/VaccineTo be administered subcutaneously as 1 mg admixed with Hiltonol, Poly-ICLC as a single dose.
Hiltonol Poly-ICLC-adjuvant
Biological/VaccineVaccine adjuvant
Local signs and symptoms will be collected for a minimum of 14 days following receipt of adjuvanted CD40.HIVRI.Env (VRIPRO)
Local events at the injection site include pain/tenderness, induration and erythema. These will be graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Systemic reactogenicity signs and symptoms will be collected
Systemic events include increased body temperature, fatigue, generalized myalgia, generalized arthralgia, headache, chills, and nausea. These will be graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events,Corrected Version 2.1, July 2017 (exceptions apply)
Number of SAEs leading to early participant withdrawal or permanent discontinuation will be collected throughout the study and for 1 year following study product
Number of MAAEs leading to early participant withdrawal or permanent discontinuation will be collected throughout the study and for 1 year following study product
Response rate of serum HIV-1-specific IgG binding antibodies against autologous and heterologous Env antigens as assessed by binding Ab multiplex assay (BAMA)
Magnitude of serum HIV-1-specific IgG binding antibodies against autologous and heterologous Env antigens as assessed by binding Ab multiplex assay (BAMA)
Response rate of serum-HIV-1 specific IgG binding antibodies against autologous and heterologous V1V2 antigens as assessed by BAMA
Magnitude of serum-HIV-1 specific IgG binding antibodies against autologous and heterologous V1V2 antigens as assessed by BAMA
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