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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vir Biotechnology, Inc.
• Collaborator: Bill and Melinda Gates Foundation

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