The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies

Chronic HIV Infection Clinical Trial

Official title: 426c.Mod.Core-C4b Adjuvanted With 3M-052-AF + Alum Immunization in Combination With an Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of VRC01-lineage Antibodies

Status Recruiting

Clinical Trial Summary

This is a multicenter controlled interventional trial. This phase 1 trial is the first study to assess 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + aluminum hydroxide suspension (Alum) in people living with HIV (PLWH).

Clinical Trial Description

The aim of this study is to combine the ability of germline (GL)-targeting HIV-1 Envelope protein (Env)-derived immunogens to activate naïve B cells that express the unmutated GL forms of VRC01-class broadly neutralizing antibodies (bnAbs) with the booster capabilities of viral Envs that are expected to circulate in persons living with chronic HIV. The goals are: 1) to elicit VRC01-class GL and intermediate stage antibody responses in PLWH; 2) to identify the viral Envs that guided the maturation of the GL-VRC01 responses elicited by the GL-targeting Env immunogen; 3) during the time when viremia is detectable, the investigator will assess the stage of maturation of these VRC01 antibodies and if they affect viral replication; and 4) investigate how the virus may evolve to escape the activity of these antibodies. ;

Related Conditions & MeSH terms

• Chronic HIV Infection
• HIV Infections

• NCT number: NCT06006546
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Recruiting
• Phase: Phase 1
• Start date: January 3, 2024
• Completion date: December 20, 2025