RT Journal Article
SR Electronic
T1 Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP 873
OP 880
DO 10.1212/01.wnl.0000335762.42177.07
VO 72
IS 10
A1 Yann Mikaeloff
A1 Guillaume Caridade
A1 Samy Suissa
A1 Marc Tardieu
YR 2009
UL http://n.neurology.org/content/72/10/873.abstract
AB Background: The risk of CNS inflammatory demyelination associated with hepatitis B (HB) vaccine is debated, with studies reporting conflicting findings. Methods: We conducted a population-based case-control study where the cases were children with a first episode of acute CNS inflammatory demyelination in France (1994–2003). Each case was matched on age, sex, and geographic location to up to 12 controls, randomly selected from the general population. Information on vaccinations was confirmed by a copy of the vaccination certificate. The odds ratios (ORs) of CNS inflammatory demyelination associated with HB vaccination were estimated using conditional logistic regression. Results: The rates of HB vaccination in the 3 years before the index date were 24.4% for the 349 cases and 27.3% for their 2,941 matched controls. HB vaccination within this period was not associated with an increase in the rate of CNS inflammatory demyelination (adjusted OR, 0.74; 0.54–1.02), neither >3 years nor as a function of the number of injections or brand type. When the analysis was restricted to subjects compliant with vaccination, HB vaccine exposure >3 years before index date was associated with an increased trend (1.50; 0.93–2.43), essentially from the Engerix B vaccine (1.74; 1.03–2.95). The OR was particularly elevated for this brand in patients with confirmed multiple sclerosis (2.77; 1.23–6.24). Conclusions: Hepatitis B vaccination does not generally increase the risk of CNS inflammatory demyelination in childhood. However, the Engerix B vaccine appears to increase this risk, particularly for confirmed multiple sclerosis, in the longer term. Our results require confirmation in future studies. ADEM = acute disseminated encephalomyelitis; BCG = Bacille Calmette–Guèrin; HB = hepatitis B; MS = multiple sclerosis; OR = odds ratio.