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Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood

From Assistance Publique-Hôpitaux de Paris, Service de Neurologie Pédiatrique and Centre de Référence National des Maladies Inflammatoires du Cerveau de l’Enfant (Y.M., G.C., M.T.), INSERM U822 (Y.M., G.C.), and INSERM U802 (M.T.), Hôpital Bicêtre, Université Paris Sud 11, Le Kremlin Bicêtre, France; and Division of Clinical Epidemiology (S.S.), McGill University and Royal Victoria Hospital, Montreal, Canada.

Address correspondence and reprint requests to Dr. Yann Mikaeloff, Service de Neurologie Pédiatrique, CHU Bicêtre, Assistance Publique-Hôpitaux de Paris, 78 Avenue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex, France yann.mikaeloff{at}bct.aphp.fr

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.

Editorial, page 870

e-Pub ahead of print on October 8, 2008, at www.neurology.org.

Funded by grants from the "Agence Française de Sécurité Sanitaire des Produits de Santé" (AFSSAPS), the "Agence Nationale de Recherche sur le SIDA et les hépatites" (ANRS), and the French Ministry of Health by a grant from the "Projet Hospitalier de Recherche Clinique" and by the "Direction Générale de la Santé." S. Suissa holds a Distinguished Scientist award from the Canadian Institutes of Health Research (CIHR).

Disclosure: The authors report no disclosures.

Received March 21, 2008. Accepted in final form August 6, 2008.

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