Background/Purpose: This study investigated whether the human papillomavirus (HPV) vaccine [types 6, 11, 16, 18] is associated with a modified risk of autoimmune disorders (AIDs). It carried out a case-control study within the population targeted for HPV vaccination.

Methods: The following AIDs were studied: central demyelination, Guillain-Barré syndrome, connective tissue disorders (lupus, rheumatoid arthritis, myositis, dermatomyositis, undifferentiated connective tissue disorder), type 1 diabetes, autoimmune thyroid disorders (Graves’ disease, Hashimoto’s thyroiditis) and immune thrombocytopenia. A network of specialist centers (internal medicine, neurology, rheumatology, paediatrics, endocrinology, dermatology) throughout France recruited newly-diagnosed cases in females 14 – 26 years-old. Cases were diagnosed according to standardized criteria. Controls were recruited from general practice settings and matched to cases on age (within ± one, ± three, ± six or ± 12 months successively if no match was found for cases under 18 years-old, within ± 12 or ± 24 months for cases 18 years-old or older), region of residence (northern or southern France) and recruitment consultation date (within ± three or ± nine months). Vaccinations and other potential risk factors for AIDs were assessed in a standardized telephone interview of patients or their parents. The interviewers were blind to case/control status.

Results: Between December 2007 and April 2011, 113 specialist centers recruited 248 definite cases of AIDs which were matched to 1001 controls. 97.4% of reported vaccinations against HPV [types 6, 11, 16, 18] were confirmed using medical records from the patients or their general practitioners. A smaller proportion of cases (26 or 10.5%) than controls (232 or 23.2%) received the HPV vaccine [types 6, 11, 16, 18] within predefined time windows up to 24 months before the index date but the difference was not statistically significant (adjusted odds ratio 0.72, 95% confidence interval 0.45, 1.18). No association was found when each AID was considered separately, although these analyses were based on small numbers of cases, or when considering various time windows prior to the index date, the inclusion of uncertain exposures to vaccination and unconfirmed cases. The specialist centers reported no important increase in incidence for any of the AIDs in the population eligible for HPV vaccination.

Conclusion: No evidence of an increased risk of the studied AIDs was observable following vaccination with HPV vaccine [types 6, 11, 16, 18] for the time window of study available.  The study lacked the power to conclude on individual disorders taken separately. The study observed no unusual accrual, in a large series of centers specialized in AIDs, of incident cases of any of the diseases surveyed in young females, at a time when one-third of them were getting vaccinated against HPV, mainly by HPV vaccine types 6, 11, 16, 18.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/human-papillomavirus-vaccine-types-6-11-16-18-gardasil-and-autoimmune-disorders-safety-assessment-using-the-pharmacoepidemiologic-general-research-extension-system/