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.
Background Reports of multiple sclerosis developing after hepatitisB vaccination have led to the concern that this vaccine mightbe a cause of multiple sclerosis in previously healthy subjects.
Methods We conducted a nested casecontrol study in twolarge cohorts of nurses in the United States, those in the Nurses'Health Study (which has followed 121,700 women since 1976) andthose in the Nurses' Health Study II (which has followed 116,671women since 1989). For each woman with multiple sclerosis, weselected as controls five healthy women and one woman with breastcancer. Information about hepatitis B vaccination was obtainedby means of a mailed questionnaire and was confirmed by meansof vaccination certificates. The analyses included 192 womenwith multiple sclerosis and 645 matched controls (534 healthycontrols and 111 with breast cancer) and were conducted withthe use of conditional logistic regression.
Results The multivariate relative risk of multiple sclerosisassociated with exposure to the hepatitis B vaccine at any timebefore the onset of the disease was 0.9 (95 percent confidenceinterval, 0.5 to 1.6). The relative risk associated with hepatitisB vaccination within two years before the onset of the diseasewas 0.7 (95 percent confidence interval, 0.3 to 1.8). The resultswere similar in analyses restricted to women with multiple sclerosisthat began after the introduction of the recombinant hepatitisB vaccine. There was also no association between the numberof doses of vaccine received and the risk of multiple sclerosis.
Conclusions These results indicate no association between hepatitisB 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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