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NCT05471076 · ClinicalTrials.gov registry record · 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

A Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Active
Registry status
Phase 1
Development phase
52
Enrollment target
6
Study locations

NCT05471076 is a Phase 1 study of HIV-1-infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT05471076, a Phase 1 study of HIV-1-infection, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
52 participants
Enrollment target
6
Study locations

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

HIV-1-infection

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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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, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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.

NCT05471076 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, California, Georgia.

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.

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).

Who is sponsoring clinical trial NCT05471076?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.