RecruitingPhase 1NCT06796686

Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

42 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This is a clinical trial testing a new experimental HIV vaccine approach. It tests whether giving a specific "priming" vaccine followed by multiple "booster" shots (all using a special adjuvant to strengthen immune response) can generate protective antibodies against HIV in healthy adults who do not have HIV. **You may be eligible if...** - You are between 18 and 55 years old - You are HIV-negative and in generally good health - You are available for all clinic follow-up visits and willing to undergo a blood collection procedure (leukapheresis) - You are not currently enrolled in another investigational drug study (or can get approval) **You may NOT be eligible if...** - You have HIV or a serious chronic illness - You are pregnant or not using adequate contraception - You have a condition or risk factor that the study team determines makes participation unsafe - You are already taking an investigational drug in another trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL426c.Mod.Core-C4b

426c.Mod.Core-C4b is supplied at a concentration of 2 mg/mL, 0.55 mL per vial.

BIOLOGICALHxB2.WT.Core-C4b

HxB2.WT.Core-C4b is supplied at a concentration of 1 mg/mL, 0.5 mL per vial

BIOLOGICAL3M-052-AF adjuvant

immune response modifier (IRM)

OTHERAluminum hydroxide suspension (Alum) adjuvant

Alhydrogel.

OTHERDiluent

Tris-NaCl buffer


Locations(6)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

Ponce de Leon Center CRS

Atlanta, Georgia, United States

The Hope Clinic of the Emory Vaccine Research Center; Emory University

Decatur, Georgia, United States

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, United States

Columbia Physicians & Surgeons

New York, New York, United States

NY Blood Center CRS

New York, New York, United States

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NCT06796686


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