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BRILLIANT 001

A Phase 1 HIV Vaccine Trial to evaluate the Safety and Immunogenicity of BG505 GT1.1 and 426c.Mod.Core-C4b Immunogens in prime-boost Combinations with 3M-052-AF/ Alum Adjuvant in HIV-negative Adults

 

Study Overview

This Phase 1 clinical trial is designed to evaluate the safety and immune response of two experimental HIV vaccines, BG505 GT1.1 and 426c.Mod.Core-C4b, in HIV-negative adults. Using a prime-boost approach, the trial will assess these immunogens when combined with the 3M-052-AF and Alum adjuvants to understand their potential to generate effective antibody responses against HIV.

 

Primary Objectives

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Safety and Tolerability: Determine the safety profile and tolerability of BG505 GT1.1 and 426c.Mod.Core-C4b in combination with 3M-052-AF and Alum adjuvants.

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Antibody Response: Measure the quality and quantity of antibodies produced, focusing on Env-specific binding and neutralizing antibodies to assess potential protective effects.

Study Design

This randomized, controlled, double-blind trial takes place across multiple research sites, ensuring robust data collection. Participants will receive the vaccine candidates intramuscularly, following a precise dosing schedule as per the study protocol.

This study represents a promising step toward developing an effective HIV vaccine by advancing our understanding of immune responses and antibody generation.