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September 14, 2004; 63 (5) Articles

Recombinant hepatitis B vaccine and the risk of multiple sclerosis

A prospective study

Miguel A. Hernán, Susan S. Jick, Michael J. Olek, Hershel Jick
First published September 13, 2004, DOI: https://doi.org/10.1212/01.WNL.0000138433.61870.82
Miguel A. Hernán
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Susan S. Jick
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Michael J. Olek
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Hershel Jick
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Citation
Recombinant hepatitis B vaccine and the risk of multiple sclerosis
A prospective study
Miguel A. Hernán, Susan S. Jick, Michael J. Olek, Hershel Jick
Neurology Sep 2004, 63 (5) 838-842; DOI: 10.1212/01.WNL.0000138433.61870.82

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Abstract

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 May 8, 2004.
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Letters: Rapid online correspondence

  • Recombinant hepatitis B vaccine and the risk of multiple sclerosis: A prospective study
    • C Raina MacIntyre, National Centre for Immunisation Research, Australia, NCIRS, Children's Hospital at Westmead and University of Sydney, Westmead, 2145, NSW, AustraliaRainaM@chw.edu.au
    • Heath Kelly, Damien Jolley, Helmut Butzkueven, Daniel Salmon, Neal Halsey, Lawrence H Moulton
    Submitted November 11, 2004
  • Recombinant hepatitis B vaccine and the risk of multiple sclerosis: A prospective study
    • Frank DeStefano, Centers for Disease Control and Prevention, MS E61, 1600 Clifton Rd., Atlanta, GA 30333fxd1@cdc.gov
    • Eric S. Weintraub and Robert T. Chen
    Submitted November 11, 2004
  • Reply to DeStefano and MacIntyre
    • Miguel A Hernán, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115miguel_hernan@post.harvard.edu
    • Susan S. Jick
    Submitted November 11, 2004
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