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About the Authors:
Joseph Hinchey
Affiliation: Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York, United States of America
Bo Y. Jeon
Affiliation: Department of Microbiology, Yonsei University College of Medicine, Seoul, Republic of Korea
Holly Alley
Affiliation: Duke Human Vaccine Institute, Durham, North Carolina, United States of America
Bing Chen
Affiliation: Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York, United States of America
Michael Goldberg
Affiliation: Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York, United States of America
Steven Derrick
Affiliation: Center for Biologics Evaluation, US Food and Drug Administration, Bethesda, Maryland, United States of America
Sheldon Morris
Affiliation: Center for Biologics Evaluation, US Food and Drug Administration, Bethesda, Maryland, United States of America
William R. Jacobs Jr
Affiliations Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York, United States of America, Howard Hughes Medical Institute, Albert Einstein College of Medicine, Bronx, New York, United States of America
Steven A. Porcelli
Affiliations Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York, United States of America, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, United States of America
Sunhee Lee
* E-mail: [email protected]
Affiliation: Duke Human Vaccine Institute, Durham, North Carolina, United States of America
Introduction
Tuberculosis is a devastating disease, and despite the availability of therapeutic drugs and widespread vaccination with BCG, it remains a serious global health issue, infecting nearly a third of the world population and causing 2–3 million deaths annually [1]. Since initiating BCG vaccination in the 1920s, more than three billion people have been vaccinated with BCG [2]. However, the benefits and drawbacks of BCG have been debated since its early use. Ongoing concerns and controversies include the potential for disseminated infection by BCG in immunosuppressed hosts, loss of sensitivity to tuberculin as a diagnostic reagent, and the failure of BCG to show efficacy in the prevention of pulmonary TB in a number of trials in developing countries [3], [4], [5]. There have been numerous hypotheses to explain the inadequate protective effect of BCG against pulmonary TB. Factors related directly to the vaccine, such as inappropriate treatment and storage of the vaccine and strain variability...