Journal Article

Ethical Issues in Tuberculosis Vaccine Trials

Dixie E. Snider

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 30, issue Supplement_3, pages S271-S275
Published in print June 2000 | ISSN: 1058-4838
Published online June 2000 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/313872
Ethical Issues in Tuberculosis Vaccine Trials

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Bacille Calmette-Guérin (BCG) vaccines are widely used, even though estimates of efficacy have ranged from zero to 80%. BCG is a relatively safe vaccine, but it can cause disseminated infection, especially in immunocompromised hosts. Thus, the development of a more reliably efficacious and safer vaccine is important to the control of tuberculosis. The testing of any new vaccine in human populations presents a number of ethical challenges that must be addressed. These include (1) the appropriateness of conducting such trials in developing countries; (2) the use of a BCG-vaccinated population as the control group; (3) the provision of tuberculin skin-test screening and preventive therapy to study participants; (4) the involvement of various “communities” in the trial(s); (5) the structure and process of ethical review; (6) establishing an effective method of obtaining informed consent; and (7) the roles and responsibilities of researchers and others in ensuring that trial results are available to the study population after the trial ends.

Journal Article.  3941 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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