HIV-1 Envelope Trimer Vaccine for HIV Prevention

Recruiting at 11 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new two-step HIV treatment in humans for the first time. The first shot introduces a protein to help the immune system recognize HIV. The second shot uses mRNA to boost the immune response by teaching the body to make a part of the virus. The goal is to produce antibodies that can neutralize HIV.

Eligibility Criteria

Adults aged 18-55 in good health, willing to consent and available for follow-up. They must not be at high risk of HIV, agree to avoid risky behaviors, and use effective birth control if applicable. Excluded are those with BMI ≥ 40, diabetes, immunodeficiencies, certain allergies or conditions that could compromise safety.

Inclusion Criteria

For volunteers of reproductive potential, agreement to use effective means of birth control and negative beta human chorionic gonadotropin (β-HCG) pregnancy test on day of enrollment

Platelets between 125,000 to 550,000/mm3

I am willing and able to understand and sign the consent form.

Exclusion Criteria

Previous or current recipient of an investigational HIV vaccine

I have had myocarditis or pericarditis in the past.

Receipt of non-HIV experimental vaccine(s) within the last 1 year with exceptions

Treatment Details

Interventions

• V3G CH848 mRNA-Tr2 (mRNA Lipid Nanoparticles)
• V3G CH848 Pr-NP1 (Virus Therapy)

Trial Overview The trial tests a prime-boost vaccine strategy against HIV using ferritin nanoparticles (V3G CH848 Pr-NP1) followed by an mRNA lipid nanoparticle (V3G CH848 mRNA-Tr2). It aims to induce antibodies targeting the virus's envelope protein.

Participant Groups

Group I: Group 4: V3G CH848 Pr-NP1 with ACU-026-001-1 Experimental Treatment 3 Interventions

3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Group II: Group 3: V3G CH848 Pr-NP1 with 3M-052-AF + Alum Experimental Treatment 4 Interventions

3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Group III: Group 2: Low dose V3G CH848 Pr-NP1 with ACU-026-001-1 Experimental Treatment 3 Interventions

3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Group IV: Group 1: Low dose V3G CH848 Pr-NP1 with 3M-052-AF + Alum Experimental Treatment 4 Interventions

3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+