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

NCT ID: NCT04725877

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2022-12-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

VIR-1111

Group Type: EXPERIMENTAL

VIR-1111

Intervention Type: BIOLOGICAL

VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.

Interventions

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.

Intervention Type: BIOLOGICAL

Placebo

A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males or healthy females of non-child-bearing potential between the ages of 18 to 50 at the time of screening
• Positive CMV serostatus
• Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
• Willing to use condoms during intercourse through Week 36 or the end of the study
• Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
• Willing to comply with the protocol requirements regarding donation of blood, sperm or other tissues
• In the opinion of the Investigator, generally in good health as determined from medical history and no clinically significant findings from physical examinations, vital signs, and laboratory values

Exclusion Criteria

• Live in a home with children under the age of 6
• Routine provision of child care to children under the age of 6
• Have close contact with immunocompromised individuals
• Have close contact with pregnant women or a partner planning to become pregnant during the course of the study
• Health care provider who routinely comes into contact with immunosuppressed patients or pregnant women
• Participant is immunocompromised
• Participant has an autoimmune disorder
• Positive HIV test at the time of study screening
• Receipt of another investigational HIV or CMV vaccine candidate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigative Site

Miami, Florida, United States

Investigative Site

Seattle, Washington, United States

Investigative Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

VIR-1111-2001

Identifier Type: -

Identifier Source: org_study_id