Hepatitis B vaccination and first central nervous system demyelinating events: Reanalysis of a case–control study using the self-controlled case series method

• Published in: Vaccine Vol. 25; no. 31; pp. 5938 - 5943
• Main Authors: Hocine, M.N, Farrington, C.P, Touzé, E, Whitaker, H.J, Fourrier, A, Moreau, T, Tubert-Bitter, P
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01-08-2007; Elsevier; Elsevier Limited
• Subjects: Age; Allergy and Immunology; Biological and medical sciences; Case series; Case studies; Case-Control Studies; Central Nervous System; Central Nervous System Diseases - chemically induced; Central Nervous System Diseases - epidemiology; Confidence intervals; Data Interpretation, Statistical; Demyelinating Diseases - chemically induced; Demyelinating Diseases - epidemiology; Drug therapy; Hepatitis; Hepatitis B - prevention & control; Hepatitis B vaccination; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Human viral diseases; Humans; Immunization; Infectious diseases; Life Sciences; Medical sciences; Methodology; Methods; Multiple sclerosis; Nervous system; Risk factors; Santé publique et épidémiologie; Statistics; Studies; Vaccination; Viral diseases; Viral hepatitis; Hepatitis B vaccination; Multiple sclerosis; Case series; Nervous system diseases; Vaccination; Central nervous system; Hepatic disease; Case control study; Method; Inflammatory disease; Infection; Viral hepatitis B; Viral disease; Central nervous system disease; Digestive diseases
• ISSN: 0264-410X; 1873-2518; 0264-410X
• DOI: 10.1016/j.vaccine.2007.05.032

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.