NCT05854381

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the HCMV-HIV Vaccine Candidate VIR-1388 in Adult Participants With Overall Good Health and Without HIV

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without HIV. Participants will be enrolled concurrently into 1 of 3 dose levels of VIR-1388 or placebo. The overall study design includes 2 study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule. Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as Part A . There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.

Conditions

• HIV I Infection

Interventions

Type	Name	Description
BIOLOGICAL	VIR-1388	VIR-1388 is given by subcutaneous injection
BIOLOGICAL	Placebo	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

Timeline

• Start date: 2023-09-19
• Primary completion: 2025-09-19
• Completion: 2025-11-19
• First posted: 2023-05-11
• Last updated: 2026-03-03

Locations

10 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study