Hepatitis B vaccination and first central nervous system demyelinating events: reanalysis of a case-control study using the self-controlled case series method.
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.
Hocine
M N
MN
INSERM U780, Université Paris XI, Villejuif, France. m.hocine@open.ac.uk
Farrington
C P
CP
Touzé
E
E
Whitaker
H J
HJ
Fourrier
A
A
Moreau
T
T
Tubert-Bitter
P
P
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
D017325:Hepatitis B Vaccines