RISK OF DEMYELINATING DISEASE AFTER HEPATITIS B VACCINATION

T.M Verstraeten, T. Verstraeten, F. DeStefano, L. Jackson, P. Benson, C. Okoro, S. Black, H. Shinefield, J. Mullooly, R. Chen

CDC, USA., Group Health Cooperative of Puget Sound, USA., Kaiser Permanente of Northern California, USA

Background: Concerns that hepatitis B vaccination may cause or precipitate demyelinating diseases such as multiple sclerosis (MS), have disrupted hepatitis B vaccination programs in France and elsewhere. We conducted a case-control study to assess this association among members of three large managed care organizations (MCOs) that participate in the CDC’s Vaccine Safety Datalink (VSD) project.

Methods: We screened the automated records from the VSD for all cases of demyelinating disease diagnosed after 1995. We then confirmed each case by medical record review. One to three controls were subsequently matched to each case, by date of birth, gender, MCO membership and cumulative enrollment time. The first date of demyelinating symptoms recorded in the charts served as the index date. History of hepatitis B vaccination was ascertained through chart review and telephone interviews. Mention in either source of vaccination prior to the index date was used as an indicator of vaccination. We used conditional logistic regression models to estimate the risk of MS or optic neuritis associated with vaccination. We adjusted the estimates for race and ethnic origin.

Results: We matched 422 cases to 921 controls; 86 (20.4%) cases and 194 (21.1%) controls had received any hepatitis B vaccine, 62 (15.6%) and 123 ( 14.5%) of which, respectively, occurred prior to the index date. The odds ratio for ever being vaccinated against hepatitis B prior to symptom onset was 1.10 (95 % CI: 0.71-1.70) unadjusted and 1.09 (95% CI: 0.70 – 1.70) adjusted.

Conclusion: Hepatitis B vaccination was not associated with increased risk of demyelinating disease in our study population. Future analyses will compare the risk of demyelinating disease in specific risk intervals following hepatitis B vaccination.

KEY WORDS: hepatitis B vaccination, demyelinating diseases, MS