NCT04453293View on ClinicalTrials.gov

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

PHASE3RecruitingINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Tuberculosis Infection
Interventions
BIOLOGICAL

BCG (Tokyo 172) vaccine

Freeze-Dried Glutamate Bacillus Calmette-Guérin BCG Vaccine (Japan BCG Laboratory), 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region

DRUG

Placebo

Placebo vaccine diluent, 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region

Trial Locations (7)

20010

RECRUITING

MedStar Washington Hospital Center/MedStar Health Research Institute, Washington D.C.

21205

RECRUITING

Johns Hopkins Bloomberg School of Public Health, Department of International Health, Center for Immunization Research, Baltimore

30030

TERMINATED

Hope Clinic of the Emory University Vaccine Center, Emory University, Decatur

77030

ACTIVE_NOT_RECRUITING

Baylor College of Medicine, Houston

84108

ACTIVE_NOT_RECRUITING

University of Utah School of Medicine, Salt Lake City

06510

ACTIVE_NOT_RECRUITING

Yale University School of Medicine, New Haven

02115

ACTIVE_NOT_RECRUITING

The Brigham and Women's Hospital Center for Clinical Investigation, Boston

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Uniformed Services University of the Health Sciences

FED

lead

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER