Hepatitis B vaccine and risk of relapse after a first childhood episode of CNS inflammatory demyelination

Assistance publique-Hôpitaux de Paris, Service de Neurologie Pédiatrique, Hôpital Bicêtre, INSERM U802, Université Paris Sud 11, Le Kremlin Bicêtre, France.
Brain (Impact Factor: 9.2). 05/2007; 130(Pt 4):1105-10. DOI: 10.1093/brain/awl368
Source: PubMed


Public concern about possible increases in the risk of multiple sclerosis associated with hepatitis B vaccination has led to low vaccination coverage. We investigated whether this vaccination after a first episode of acute CNS inflammatory demyelination in childhood increased the risk of conversion to multiple sclerosis. We studied the French Kid Sclérose en Plaques (KIDSEP) neuropaediatric cohort of patients enrolled between 1994 and 2003 from their first episode of acute CNS inflammatory demyelination (inclusion in the cohort) until the occurrence of a second episode, up to 2005. A Cox proportional hazards model of time-dependent vaccine exposure was used to evaluate the effect of vaccination (hepatitis B, tetanus) during follow-up on the risk of second episode occurrence (conversion to multiple sclerosis). The cohort included 356 subjects with a mean follow-up of 5.8 years (SD 2.7). Relapse occurred in 146 (41%) subjects during follow-up; 33 subjects were exposed to hepatitis B vaccine and 28 to tetanus vaccine at some time during follow-up. The adjusted hazard ratio (HR) for relapse occurring within 3 years of hepatitis B vaccination was 0.78 (0.32-1.89) and during any time period was 1.09 (0.53-2.24). The adjusted HR for relapse occurring within 3 years of tetanus vaccination was 0.99 (0.58-1.67) and during any time period was 1.08 (0.63-1.83). We conclude that vaccination against hepatitis B or tetanus after a first episode of CNS inflammatory demyelination in childhood does not appear to increase the risk of conversion to multiple sclerosis, although the possibility of a small increase in risk cannot be excluded.

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Available from: Samy Suissa
    • "En 1998, e ´voquant le principe de précaution, le ministère de la Santé a suspendu la campagne de vaccination des enfants de 11 ans au collège, entraıˆnant un recul important de la vaccination des préadolescents [4]. De 2003 a ` 2007, la polémique a continué bien que différentes e ´tudes de faible niveau de preuve et aux résultats contradictoires n'aient pas remis en cause la balance bénéfice– risque largement favorable a ` la vaccination [5] [6] [7]. Dans ce contexte, le Haut conseil de la Santé publique (HCSP) a maintenu sa recommandation de vaccination des groupes a ` risque et des nourrissons avec un rattrapage pour les enfants et les adolescents [8]. "
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    ABSTRACT: The French controversy over the possible risks of vaccination against hepatitis B seems to have resulted in a slowdown or delay in vaccination of target populations since the mid-1990s. This article reports the results of the analysis of vaccination coverage against hepatitis B of first-grade children in Paris between 2002 and 2008. Retrospective and descriptive study of vaccination status against hepatitis B for children born between 1997 and 2002 and attending first grade in a Paris school between 2002 and 2008, using anonymous data from the prevention service of the city of Paris. The analysis included 108,114 children whose Health Book (carnet de santé) included sociodemographic data and the presence of at least one diphtheria-tetanus-polio vaccination. Among these targeted children, 66,597 (61.6%) had started a vaccination against hepatitis B, 61,190 (56.6%) were considered "vaccinated" (at least three doses), and 47,489 (43.9%) "adequately vaccinated" (at least three doses respecting the prescribed intervals between injections). The sociodemographic factors associated with hepatitis B coverage were as follows: Paris arrondissement where the child attended school, year, and country of birth. Nearly 40% of the children in this cohort had not been vaccinated against hepatitis B before beginning first grade. They have now become adolescents aged 12-17 years. Current data indicate that only one-third of them have benefited from the catch-up campaign. This finding reinforces the need for vigilance on the vaccination status of adolescents against hepatitis B. Copyright © 2015 Elsevier Masson SAS. All rights reserved.
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    • "Mikaeloff et al. [28] in a French study found no evidence of increased risk of developing a first episode of MS up to 3 years after receiving vaccination. In a second study by the same authors, no evidence was found of any increased rate of relapse after a first demyelinating event when patients were subsequently vaccinated against hepatitis B or tetanus [29]. In a carefully performed casecontrol analysis, these investigators [30] showed a trend for the Engerix B vaccine to increase the risk of MS in the long term. "
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    ABSTRACT: Multiple sclerosis (MS), a chronic inflammatory autoimmune disease of the central nervous system (CNS) commonly diagnosed in adults, is being recognized increasingly in children. An estimated 1.7%-5.6% of all patients with MS have clinical symptoms before reaching the age of 18 years. In comparison with adults, the diagnosis of MS in children can be more difficult, being dismissed or misdiagnosed as other clinical disorders. Although adults and children share basic aspects of the disorder, children have distinctive clinical features, neuroimaging, laboratory, and courses of the disease. The 2010 McDonald criteria have simplified the requirements for establishing the diagnosis of MS and have been proposed to be applicable for the diagnosis of pediatric MS, mainly in children 12 years and older. This paper describes the distinctive features of common pediatric demyelinating disorders, including MS, and summarizes the most recent advances based on the available literature.
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    • "), which, in 1994, was only of concern to about 25 000 persons at that time. Likewise, whereas any reasonable physician in this country was concerned by the risk of triggering MS in exposing some 10-million of children to hepatitis B vaccination, Mikaeloff et al., with the obvious support of their Ministry, were apparently very happy to claim that out of the… 33 children with pre-existing MS and then exposed to this vaccine, there was no evidence of any risk of relapse [8]. How nice and reassuring! "
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    ABSTRACT: When the Mikaeloff et al. study was announced, everybody (myself included) understood that the cases would be the 472 MS-diagnosed children in the "KIDMUS" cohort—an alarming number of children because pediatric MS is not a recognized medical condition. Therefore, it would be inter- esting to know why Mikaeloff et al. retained only 143 (less than one third) of these 472 children in their study. There were a number of reasons to be highly suspicious of the validity of this study by Mikaeloff et al. besides Archives of Pediatrics & Adoles- cent Medicine publishing this problematic investigation and making it available without cost. Was it really necessary to publish an accompanying editorial touting this study under the fallacious pretext of "science"? To conclude, Mikaeloff et al.'s investigation failed to answer the question which triggered its planning and execution, and was perfectly summa- rized by Tardieu—one of its co-authors—in 2004: Why, in a period where the main change in environment was vaccination against hepatitis B, did the 1990s show a burst of pediatric MS, a disease extremely rare in that age group and whose overall epidemiology, anyway, has normally been quite stable? To be more precise, why, following this vaccination campaign, did the KIDMUS cohort show a 25-fold increase in the frequency of pediatric MS as compared to previous records? A question strangely consistent with a more general one: "Why, as compared to the latest record prior to the vaccination campaign, did the widely accepted estimation of MS cases in the French population show an increase from about 25,000 at baseline in 1993 to the current 80,000-90,000?" To say nothing about this second interesting question: "Whatever its real cause, why did such an alarming situa- tion not trigger from the French authority any investigation other than that of Mikaeloff et al.?"
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