title: Hepatitis B vaccination and first central nervous system demyelinating events: reanalysis of a case-control study using the self-controlled case series method.
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.
authors.affiliation: INSERM U780, Université Paris XI, Villejuif, France. m.hocine@open.ac.uk
authors.forename: M N
authors.initials: MN
authors.lastname: Hocine
authors.forename: C P
authors.initials: CP
authors.lastname: Farrington
authors.forename: E
authors.initials: E
authors.lastname: Touzé
authors.forename: H J
authors.initials: HJ
authors.lastname: Whitaker
authors.forename: A
authors.initials: A
authors.lastname: Fourrier
authors.forename: T
authors.initials: T
authors.lastname: Moreau
authors.forename: P
authors.initials: P
authors.lastname: Tubert-Bitter
mesh_terms: D016022:Case-Control Studies; D002490:Central Nervous System; D002493:Central Nervous System Diseases / Q000139:chemically induced* / Q000453:epidemiology; D003627:Data Interpretation, Statistical; D003711:Demyelinating Diseases / Q000139:chemically induced* / Q000453:epidemiology; D006509:Hepatitis B / Q000517:prevention & control; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D014611:Vaccination
chemical_list: D017325:Hepatitis B Vaccines