Status:
COMPLETED
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
Lead Sponsor:
Vir Biotechnology, Inc.
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
HIV I Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 dose...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04725877
Start Date
December 28 2020
End Date
December 5 2022
Last Update
February 27 2023
Active Locations (3)
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1
Investigative Site
Miami, Florida, United States, 33122
2
Investigative Site
Seattle, Washington, United States, 98104
3
Investigative Site
Madison, Wisconsin, United States, 53704