Hepatitis B vaccination and first central nervous system demyelinating events: Reanalysis of a case-control study using the self-controlled case series method

Hocine, M. N.; Farrington, C. P.; Touze, E.; Whitaker, H. J.; Fourrier, A.; Moreau, T. and Tubert-Bitter, P. (2007). Hepatitis B vaccination and first central nervous system demyelinating events: Reanalysis of a case-control study using the self-controlled case series method. Vaccine, 25(31) pp. 5938–5943.

DOI: https://doi.org/10.1016/j.vaccine.2007.05.032

Abstract

The hypothesis that hepatitis B vaccination is a risk factor for multiple sclerosis has been discussed at length. The data from an earlier case-control study were reanalyzed using the self-controlled case series method. Using the matched cases from the case-control study, we found a relative incidence of 1.68, 95% CI (0.77-3.68) for the 0-60-day post-vaccination risk period; this compares to an odds ratio of 1.8, 95% CI (0.7-4.6). When an additional 53 unmatched cases not used in the case-control study were included, the relative incidence was 1.35, 95% CI (0.66-2.79). Our results throw further light on the methodological aspects of the case series method. We recommend that, when case-control studies of vaccination and adverse events are planned, case series analyses based on the cases are also undertaken when appropriate. (c) 2007 Elsevier Ltd. All rights reserved.