Loading clinical trials...

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1a, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers

NCT04725877•Vir Biotechnology, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (3)

Investigative Site

Miami, Florida, United States

Investigative Site

Seattle, Washington, United States

Investigative Site

Madison, Wisconsin, United States

Key Dates

Start Date

December 28, 2020

Primary Completion Date

December 5, 2022

Completion Date

December 5, 2022

Last Updated

February 27, 2023

Enrollment

ACTUAL participants

Conditions

HIV I Infection

Interventions

VIR-1111

BIOLOGICAL

Placebo

DRUG

Evaluating the Safety and Immunogenicity of MTBVAC

NCT05947890

HIV I InfectionTuberculosis

View study

RECRUITINGNA

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

NCT06834113

HIV I InfectionInjection Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Immunogenicity of MTBVAC

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa