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. SETTING: Two managed care organizations in California. Subjects. Number of 189,629 women who received ≥1 dose of HPV4 between 08/2006 and 03/2008. OUTCOME: 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.
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. SETTING: Two managed care organizations in California. Subjects. Number of 189,629 women who received ≥1 dose of HPV4 between 08/2006 and 03/2008. OUTCOME: 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: Sasha Bernatsky; Rosalind Ramsey-Goldman; Jeremy Labrecque; Lawrence Joseph; Jean-Francois Boivin; Michelle Petri; Asad Zoma; Susan Manzi; Murray B Urowitz; Dafna Gladman; Paul R Fortin; Ellen Ginzler; Edward Yelin; Sang-Cheol Bae; Daniel J Wallace; Steven Edworthy; Soren Jacobsen; Caroline Gordon; Mary Anne Dooley; Christine A Peschken; John G Hanly; Graciela S Alarcón; Ola Nived; Guillermo Ruiz-Irastorza; David Isenberg; Anisur Rahman; Torsten Witte; Cynthia Aranow; Diane L Kamen; Kristjan Steinsson; Anca Askanase; Susan Barr; Lindsey A Criswell; Gunnar Sturfelt; Neha M Patel; Jean-Luc Senécal; Michel Zummer; Janet E Pope; Stephanie Ensworth; Hani El-Gabalawy; Timothy McCarthy; Lene Dreyer; John Sibley; Yvan St Pierre; Ann E Clarke Journal: J Autoimmun Date: 2013-02-12 Impact factor: 7.094
Authors: Lina S Sy; Kristin I Meyer; Nicola P Klein; Chun Chao; Christine Velicer; T Craig Cheetham; Bradley K Ackerson; Jeff M Slezak; Harpreet S Takhar; John Hansen; Kamala Deosaransingh; Kai-Li Liaw; Steven J Jacobsen Journal: Hum Vaccin Immunother Date: 2017-12-14 Impact factor: 3.452
Authors: G Gross; N Becker; N H Brockmeyer; S Esser; U Freitag; M Gebhardt; L Gissmann; P Hillemanns; H Grundhewer; H Ikenberg; H Jessen; A Kaufmann; S Klug; J P Klußmann; A Nast; D Pathirana; K U Petry; H Pfister; U Röllinghof; P Schneede; A Schneider; E Selka; S Singer; S Smola; B Sporbeck; M von Knebel Doeberitz; P Wutzler Journal: Geburtshilfe Frauenheilkd Date: 2014-03 Impact factor: 2.915
Authors: Roger Baxter; Edwin Lewis; Kristin Goddard; Bruce Fireman; Nandini Bakshi; Frank DeStefano; Julianne Gee; Hung Fu Tseng; Allison L Naleway; Nicola P Klein Journal: Clin Infect Dis Date: 2016-09-01 Impact factor: 9.079