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

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV I Infection

In brief

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.

Key facts

Study ID

NCT04725877

Run by

Vir Biotechnology, Inc.

People needed

27

Starts

2020-12-28

Expected to finish

2022-12-05

Last updated by the study team

2023-02-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — Miami, Florida, United States
• Investigative Site — Seattle, Washington, United States
• Investigative Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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