NCT06006546

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

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: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Chronic HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	426c.Mod.Core-C4b	100 mcg and 300 mcg
OTHER	Adjuvant 3M-052-AF+Alum	5 mcg

Timeline

• Start date: 2024-01-03
• Primary completion: 2026-10-27
• Completion: 2026-10-27
• First posted: 2023-08-23
• Last updated: 2026-01-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study