The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies
NCT06006546 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-01-14
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).
Conditions
- Chronic HIV Infection
Interventions
- BIOLOGICAL
-
426c.Mod.Core-C4b
100 mcg and 300 mcg
- OTHER
-
Adjuvant 3M-052-AF+Alum
5 mcg
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-03
- Primary Completion
- 2026-10-27
- Completion
- 2026-10-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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