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

Conditions

• Chronic HIV Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed

Aug 23, 2023

Start date

Jan 3, 2024

Status verified

Sep 2025

Primary completion

Oct 27, 2026

Completion

Oct 27, 2026

Study Design

Enrollment

35 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1 (ATI)
  Group 1 will receive 2 doses of the vaccine at Week 0 and 12. Group 1 will transition to Schedule 2 at the Week 14 visit. The Schedule 2 "ATI with Monitoring" phase can last for 24 weeks OR until any antiretroviral therapy (ART) re-initiation criteria are met, OR the ATI can continue longer with the approval of the Protocol Safety Review Team (PSRT) and the participant's primary HIV healthcare provider. Group 1 will transition to Schedule 3, the "Follow-up on ART restart" phase that lasts until study week 64, regardless of the point where it begins.
• Experimental: Group 2 (No ATI) Control
  Group 2 transitions from Schedule 1 into Schedule 4, "Follow-up on ART," at the Week 14 visit, and remains on Schedule 4 through study week 64.

Primary Outcome Measure

The number of participants local reactogenicity signs and symptoms [ Time Frame: 14 days following each vaccination ]

Locations (8)

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