Hiltonol for HIV Prevention

Recruiting at 9 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Glucocorticoids, Immunoglobulin, Cabotegravir, others

Disqualifiers: Diabetes, Immunodeficiency, Seizures, Asthma, others

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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/MOSAICO trial.

Eligibility Criteria

This trial is for adults aged 18-60 who were previously in the HVTN706/MOSAICO study, regardless of whether they received the vaccine or placebo. Participants must be in good health, understand the study and consent process, commit to follow-up visits, not join other trials simultaneously (unless approved), and have normal physical and lab findings.

Inclusion Criteria

I was part of the MOSAICO study and followed its protocol.

I understand the study and agree to participate.

I will not join another clinical trial while in this study, unless approved.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for systemic and local reactogenicity signs and symptoms

2 weeks

Treatment Details

Interventions

• Hiltonol

Trial Overview The trial tests Hiltonol-adjuvanted CD40.HIVRI.Env (VRIPRO) through three injections at weeks 0, 4, and 24. It aims to evaluate safety and immune response in participants without HIV but who were part of a prior HIV vaccine study.

Participant Groups

Group I: Group 1- Study Vaccine Experimental Treatment 1 Intervention

MOSAICO study products

Group II: Group 2- Placebo Placebo Group 1 Intervention

MOSAICO placebo

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+