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ACTIVE NOT RECRUITING Phase 1

Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV

NCT05471076 · View on ClinicalTrials.gov ↗

Study Summary

The clinical study is designed to evaluate the ability of two priming vaccine regimens to activate and induce the maturation of cross-reactive CD4 binding site (CD4-bs) antibodies, including VRC01-class antibodies. VRC01- class antibodies are highly desirable to elicit via vaccination because they have broad cover all clades of HIV and passive administration of VRC01 monoclonal antibodies has been demonstrated to prevent acquisition of susceptible HIV strains in clinical trials. The study will assess whether B cells expressing VRC01-like B cell receptors proliferate following immunization with a 'germline-targeting' recombinant Env immunogen. The study will also test whether an immunization strategy based upon fractionated dose delivery of the immunogen may improve the maturation of VRC01-class B cells when compared to traditional bolus dosing. In addition, the study will test whether alterations in the dose of the subsequent boost immunizations affects VRC01-class B cell activation and the rate of antibody affinity maturation. The primary hypothesis of the optional boost regimen is that BG505 SOSIP.GT1.1 gp140 adjuvated with 3M-052-AF + Alum is safe and well-tolerated and will further mature B-cell lineages elicited by 426c.Mod.Core-C4b priming regimens.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL 426c.Mod.Core-C4b 30 mcg
  • BIOLOGICAL 426c.Mod.Core-C4b 100 mcg
  • BIOLOGICAL 426c.Mod.Core-C4b 300 mcg
  • BIOLOGICAL BG505

Study Locations (6)

Alabama

  • Alabama CRS — Birmingham

California

  • Bridge HIV CRS — San Francisco

Georgia

  • The Ponce de Leon Center CRS — Atlanta

Massachusetts

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

New York

  • Columbia P&S CRS — New York

Washington

  • Seattle Vaccine and Prevention CRS — Seattle

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2022-08-22
Est. Completion 2026-05-21
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05471076

The ClinicalTrials.gov registry entry for NCT05471076 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05471076 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05471076 about?

NCT05471076 is a clinical study titled "Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV". The clinical study is designed to evaluate the ability of two priming vaccine regimens to activate and induce the maturation of cross-reactive CD4 binding site (CD4-bs) antibodies, including VRC01-class antibodies. VRC01- class antibodies are highly desirable to elicit via vaccination because they h...

What is the current status of trial NCT05471076?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2022-08-22. Estimated completion is 2026-05-21.

What conditions does trial NCT05471076 study?

This clinical trial studies the following conditions: HIV-1-infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05471076?

The interventions under investigation include: Placebo (OTHER), 426c.Mod.Core-C4b 30 mcg (BIOLOGICAL), 426c.Mod.Core-C4b 100 mcg (BIOLOGICAL), 426c.Mod.Core-C4b 300 mcg (BIOLOGICAL), BG505 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05471076?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05471076 being conducted?

This trial has 6 study locations across Alabama, California, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial