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Recombinant hepatitis B vaccine and the risk of multiple sclerosis

A prospective study

From the Department of Epidemiology (Dr. Hernán), Harvard School of Public Health, Boston; Boston Collaborative Drug Surveillance Program (Drs. Susan S. Jick and Hershel Jick), Boston University, Lexington, MA; and Department of Neurology (Dr. Olek), College of Medicine, University of California, Irvine.

Address correspondence and reprint requests to Dr. Miguel Hernán, Department of Epidemiology, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115; e-mail: miguel_hernan{at}post.harvard.edu

Background: A potential link between the recombinant hepatitis B vaccine and an increased risk of multiple sclerosis (MS) has been evaluated in several studies, but some of them have substantial methodologic limitations.

Methods: The authors conducted a nested case-control study within the General Practice Research Database (GPRD) in the United Kingdom. The authors identified patients who had a first MS diagnosis recorded in the GPRD between January 1993 and December 2000. Cases were patients with a diagnosis of MS confirmed through examination of medical records, and with at least 3 years of continuous recording in the GPRD before their date of first symptoms (index date). Up to 10 controls per case were randomly selected, matched on age, sex, practice, and date of joining the practice. Information on receipt of immunizations was obtained from the computer records.

Results: The analyses include 163 cases of MS and 1,604 controls. The OR of MS for vaccination within 3 years before the index date compared to no vaccination was 3.1 (95% CI 1.5, 6.3). No increased risk of MS was associated with tetanus and influenza vaccinations.

Conclusions: These findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS, and challenge the idea that the relation between hepatitis B vaccination and risk of MS is well understood.

Received March 31, 2004. Accepted in final form May 8, 2004.

See also page 772

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