Vaccine Regimen for HIV Prevention

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

This trial is for adults without HIV who are in good health. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

Agrees not to enroll in another study of an investigational agent during participation in the trial. Approvals required if already enrolled in another clinical trial

My hemoglobin levels match the required levels for my gender and hormone therapy status.

White blood cell (WBC) count within specified range

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Exclusion Criteria

Previous receipt of certain investigational agents

History of certain reactions or conditions

I don't have any health issues that could make treatment unsafe for me.

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Treatment Details

Interventions

426c.Mod.Core-C4b (Cancer Vaccine)
HxB2.WT.Core-C4b (Cancer Vaccine)

Trial OverviewThe study tests a new vaccine strategy against HIV/AIDS. It starts with a 'prime' shot of 426c.Mod.Core-C4b with adjuvants (substances to boost immune response) followed by 'boost' shots of HxB2.WT.Core-C4b, also with adjuvants. The goal is to see if this can improve immune defense by maturing specific antibody-producing cells.

Participant Groups

3Treatment groups

Active Control

Group I: Group 1Active Control5 Interventions

One fractional dose of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b

Group II: Group 2AActive Control5 Interventions

One fractional dose and one bolus dose of 426c.Mod.Core-C4b two bolus doses of HxB2.WT.Core-C4b

Group III: Group 2BActive Control5 Interventions

One split dose and one bolus of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b