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

Vir Biotechnology

Status and phase

Completed

Phase 1

Conditions

HIV I Infection

Treatments

Drug: Placebo

Biological: VIR-1111

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04725877

VIR-1111-2001

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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