title: Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine.
abstract: OBJECTIVE
  An observational safety study of the quadrivalent human papillomavirus vaccine (HPV4) in women was conducted. This report presents findings from autoimmune surveillance. Design.  Subjects were followed for 180days after each HPV4 dose for new diagnoses of 16 prespecified autoimmune conditions.
  
  
  METHODS
  Two managed care organizations in California. Subjects.  Number of 189,629 women who received ≥1 dose of HPV4 between 08/2006 and 03/2008.
  
  
  RESULTS
  Potential new-onset autoimmune condition cases amongst HPV4 recipients were identified by electronic medical records. Medical records of those with ≥12-month health plan membership prior to vaccination were reviewed by clinicians to confirm the diagnosis and determine the date of disease onset. The incidence of each autoimmune condition was estimated for unvaccinated women at one study site using multiple imputations and compared with that observed in vaccinated women. Incidence rate ratios (IRR) were calculated. Findings were reviewed by an independent Safety Review Committee (SRC).
  
  
  RESULTS
  Overall, 1014 potential new-onset cases were electronically identified; 719 were eligible for case review; 31-40% were confirmed as new onset. Of these, no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition. None of the estimated IRR was significantly elevated except Hashimoto's disease [IRR=1.29, 95% confidence interval: 1.08-1.56]. Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions. The SRC and the investigators identified no autoimmune safety concerns in this study.
  
  
  CONCLUSIONS
  No autoimmune safety signal was found in women vaccinated with HPV4.
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA 91101, USA. chun.r.chao@kp.org
authors.forename: C
authors.initials: C
authors.lastname: Chao
authors.forename: N P
authors.initials: NP
authors.lastname: Klein
authors.forename: C M
authors.initials: CM
authors.lastname: Velicer
authors.forename: L S
authors.initials: LS
authors.lastname: Sy
authors.forename: J M
authors.initials: JM
authors.lastname: Slezak
authors.forename: H
authors.initials: H
authors.lastname: Takhar
authors.forename: B
authors.initials: B
authors.lastname: Ackerson
authors.forename: T C
authors.initials: TC
authors.lastname: Cheetham
authors.forename: J
authors.initials: J
authors.lastname: Hansen
authors.forename: K
authors.initials: K
authors.lastname: Deosaransingh
authors.forename: M
authors.initials: M
authors.lastname: Emery
authors.forename: K-L
authors.initials: KL
authors.lastname: Liaw
authors.forename: S J
authors.initials: SJ
authors.lastname: Jacobsen
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001327:Autoimmune Diseases / Q000453:epidemiology / Q000209:etiology*; D002140:California / Q000453:epidemiology; D002648:Child; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D015994:Incidence; D030361:Papillomavirus Infections / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000009:adverse effects*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines