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Original Article
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Volume 344:327-332 February 1, 2001 Number 5
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Hepatitis B Vaccination and the Risk of Multiple Sclerosis
Alberto Ascherio, M.D., Dr.P.H., Shumin M. Zhang, M.D., Sc.D., Miguel A. Hernan, M.D., Dr.P.H., Michael J. Olek, M.D., Paul M. Coplan, Sc.D., Kimberly Brodovicz, M.P.H., and Alexander M. Walker, M.D., Dr.P.H.

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 by Gellin, B. G.

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ABSTRACT

Background Reports of multiple sclerosis developing after hepatitis B vaccination have led to the concern that this vaccine might be a cause of multiple sclerosis in previously healthy subjects.

Methods We conducted a nested case–control study in two large cohorts of nurses in the United States, those in the Nurses' Health Study (which has followed 121,700 women since 1976) and those in the Nurses' Health Study II (which has followed 116,671 women since 1989). For each woman with multiple sclerosis, we selected as controls five healthy women and one woman with breast cancer. Information about hepatitis B vaccination was obtained by means of a mailed questionnaire and was confirmed by means of vaccination certificates. The analyses included 192 women with multiple sclerosis and 645 matched controls (534 healthy controls and 111 with breast cancer) and were conducted with the use of conditional logistic regression.

Results The multivariate relative risk of multiple sclerosis associated with exposure to the hepatitis B vaccine at any time before the onset of the disease was 0.9 (95 percent confidence interval, 0.5 to 1.6). The relative risk associated with hepatitis B vaccination within two years before the onset of the disease was 0.7 (95 percent confidence interval, 0.3 to 1.8). The results were similar in analyses restricted to women with multiple sclerosis that began after the introduction of the recombinant hepatitis B vaccine. There was also no association between the number of doses of vaccine received and the risk of multiple sclerosis.

Conclusions These results indicate no association between hepatitis B vaccination and the development of multiple sclerosis.


Source Information

From the Departments of Epidemiology (A.A., M.A.H., A.M.W.) and Nutrition (A.A., S.M.Z.), Harvard School of Public Health, Boston; the Multiple Sclerosis Unit, Center for Neurological Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston (M.J.O.); and Merck Research Laboratories, West Point, Pa. (P.M.C., K.B.).

Address reprint requests to Dr. Ascherio at the Department of Nutrition, Harvard School of Public Health, 665 Huntington Ave., Boston, MA 02115, or at alberto.ascherio{at}channing.harvard.edu.

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