To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV

Conditions

• HIV I Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• VIR-1388 — BIOLOGICAL
  VIR-1388 is given by subcutaneous injection
• Placebo — BIOLOGICAL
  The HT Diluent Placebo is HT buffer (20 mM histidine, 10% trehalose-dihydrate, pH 7.2) and contains no active ingredient and will be administered by subcutaneous injection

Study Details

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.

Key Dates

First listed

May 11, 2023

Start date

Sep 19, 2023

Status verified

Mar 2026

Primary completion

Sep 19, 2025

Completion

Nov 19, 2025

Study Design

Enrollment

93 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: VIR-1388, 5×10^4 ffu
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
• Experimental: VIR-1388, 5×10^5 ffu
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
• Experimental: VIR-1388, 5×10^6 ffu
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
• Placebo Comparator: Placebo
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.

Primary Outcome Measure

Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs) [ Time Frame: 12 months ]

Locations (6)

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