NCT04725877

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers

A Phase 1a, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1a, first in human study in which healthy adult participants who are considered to be at low-risk for HIV infection and are seropositive for cytomegalovirus (CMV) will receive two doses of VIR-1111 or placebo. These participants will be assessed for safety, reactogenicity, tolerability and immunogenicity. 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-1111	VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.
DRUG	Placebo	A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.

Timeline

• Start date: 2020-12-28
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2021-01-27
• Last updated: 2023-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study