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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, Hiltonol, to prevent HIV infection. Researchers aim to assess Hiltonol's effectiveness when combined with a specific vaccine series, CD40.HIVRI.Env, administered as three injections over several months. The trial seeks healthy individuals who participated in the previous HVTN 706 trial and do not have HIV. Participants should be in good overall health and have completed the vaccination schedule in the earlier study. As a Phase 1 trial, this research focuses on understanding Hiltonol's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications that might impair your immune response, like certain steroids, or if you have received certain vaccines or investigational agents recently, you may need to discuss this with the trial team.

Is there any evidence suggesting that Hiltonol is likely to be safe for humans?

Research has shown that Hiltonol, when used in a vaccine, is generally safe. It has been tested with other ingredients and triggered a good immune response without causing serious side effects. In one study, participants received Hiltonol with a vaccine, and it was well-tolerated. Most side effects were mild, such as redness at the injection site or temporary fatigue.

Another study tested Hiltonol alone and confirmed its safety for healthy individuals. This trial used only a single dose, but the results were promising for overall safety.

Since this trial for HIV prevention is in its early phase, it primarily focuses on assessing Hiltonol's safety. This phase aims to identify any potential risks before larger studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV prevention?

Researchers are excited about Hiltonol for HIV prevention because it introduces a novel approach by using an immune system booster called Poly-ICLC, which is an adjuvant enhancing the vaccine's effectiveness. Unlike traditional antiretroviral therapies that focus on controlling the virus after infection, Hiltonol aims to prevent the virus from taking hold in the first place. Additionally, this treatment is given as a subcutaneous injection, which can be easier and more convenient compared to the daily oral medications currently used. This approach could revolutionize HIV prevention by offering a proactive and potentially more accessible solution.

What evidence suggests that Hiltonol might be an effective treatment for HIV prevention?

Research has shown that Hiltonol, when used with the vaccine CD40.HIVRI.Env, could help prevent HIV. Studies have found that this combination can safely boost the body's immune system. In this trial, one group of participants will receive Hiltonol with the vaccine, while another group will receive a placebo. Hiltonol has shown promise in improving immune responses and reducing HIV infection when used correctly. These findings suggest that Hiltonol could play a crucial role in preventing HIV by strengthening the body's defenses. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Group 2 - Study product received in HVTN 706: Placebo Experimental Treatment 2 Interventions

Participants will receive Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env(VRIPRO) as a subcutaneous injection.

Group II: Group 1- Study product received in HVTN 706: Study Vaccine Experimental Treatment 2 Interventions

Participants will receive Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env(VRIPRO) as a subcutaneous injection.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06665646

Study Details | NCT06665646 | Clinical Trial to Evaluate ... Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol ... Agrees to discuss the potential for HIV acquisition and agrees to prevention counseling.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02071095

Enhancement by Poly-ICLC During HIV-1 Infection Though these drugs are very effective, they cannot cure HIV infection and must be taken each and every day at prescribed doses to maintain their beneficial ...

3. thelancet.com thelancet.com/pdfs/journals/eclinm/PIIS2589-5370(24)00424-3.pdf

Safety and immunogenicity of CD40.HIVRI.Env, a dendritic ... Seventy-two HIV-negative volunteers, aged 18–65 years and at low risk of infection, were enrolled. CD40.HIV-. RI.Env vaccine (0.3, 1.0, or 3.0 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176139/

In Situ Vaccination with Poly-ICLC Combined with ... This combination therapy was safe and effective, with two out of four patients demonstrating objective responses. These preliminary findings ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0161730

and Anti-HIV Effects on the DC-T Cell Milieu In Vitro and In Vivo In the right combination anti-HIV strategy, PICLC has the potential to limit HIV infection and boost HIV immunity. Citation: Aravantinou M, Frank I, Hallor M, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04842682

NCT04842682 | Dose Escalation Trial of CD40.HIVRI.Env ... Env adjuvanted with Poly-ICLC (Hiltonol®) with the DNA-HIV-PT123 vaccine will be safe and induce high titers of binding anti V1/V2 Env region IgG Abs and other ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11625018/

Safety and immunogenicity of CD40.HIVRI.Env, a dendritic ... Env alone or administered with DNA-HIV-PT123 was safe and induced early, and sustained anti-Env cellular and V1V2 IgG responses, identified as ...

8. trial.medpath.com trial.medpath.com/clinical-trial/38e74bc26f4c9254/nct01012700-randomized-placebo-controlled-i-safety-immunogenicity-poly-iclc-hiltonol-healthy

Study to Evaluate the Safety and Immunogenicity of Poly ICLC ... To evaluate the safety of a single dose of 2mg of poly ICLC (Hiltonol) administered to healthy volunteers. 12 months ...

9. withpower.com withpower.com/trial/phase-1-hiv-infections-1-2025-46813

Hiltonol for HIV Prevention It aims to evaluate safety and immune response in participants without HIV but who were part of a prior HIV vaccine study. How Is the Trial Designed? 2 ...