Nicola P Klein1, Kristin Goddard2, Edwin Lewis2, Pat Ross2, Julianne Gee3, Frank DeStefano3, Roger Baxter2. 1. Kaiser Permanente Vaccine Study Center, Oakland, CA, United States. Electronic address: nicola.klein@kp.org. 2. Kaiser Permanente Vaccine Study Center, Oakland, CA, United States. 3. Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Abstract
INTRODUCTION: Despite minimal evidence, public concerns that the human papillomavirus (HPV) vaccine can cause autoimmune diseases (AD) persist. We evaluated whether HPV vaccine is associated with a long-term increased risk of diabetes mellitus type 1 (DM1). METHODS: This was a retrospective cohort study in which we identified all potential DM1 cases from Kaiser Permanente Northern California (KPNC) members who were between 11 and 26 years old any time after June 2006 through December 2015. We chart reviewed a random sample of 100 DM1 cases to confirm diagnosis and to develop a computer algorithm that reliably determined symptom onset date. Our DM1 Analysis Population comprised all individuals who met membership criteria and who were age and sex eligible to have received HPV vaccine. We adjusted for age, sex, race, Medicaid, and years of prior KPNC membership by stratification using a Cox multiplicative hazards model with a calendar timeline. RESULTS: Our DM1 analysis included 911,648 individuals. Of 2613 DM1 cases identified, 338 remained in the analysis after applying our algorithm, HPV vaccine eligibility and membership criteria. Over the 10 years of the study period, comparing vaccinated with unvaccinated persons, we did not find an increased risk of DM1 associated with HPV vaccine receipt (hazard ratio 1.21, 95% Confidence Interval 0.94, 1.57). CONCLUSIONS: We found no increased risk for development of DM1 following HPV vaccination. Our study provides reassurance that during the 10-year time period after HPV vaccine was introduced, there was no substantial increased risk for DM1 following HPV vaccination.
INTRODUCTION: Despite minimal evidence, public concerns that the human papillomavirus (HPV) vaccine can cause autoimmune diseases (AD) persist. We evaluated whether HPV vaccine is associated with a long-term increased risk of diabetes mellitus type 1 (DM1). METHODS: This was a retrospective cohort study in which we identified all potential DM1 cases from Kaiser Permanente Northern California (KPNC) members who were between 11 and 26 years old any time after June 2006 through December 2015. We chart reviewed a random sample of 100 DM1 cases to confirm diagnosis and to develop a computer algorithm that reliably determined symptom onset date. Our DM1 Analysis Population comprised all individuals who met membership criteria and who were age and sex eligible to have received HPV vaccine. We adjusted for age, sex, race, Medicaid, and years of prior KPNC membership by stratification using a Cox multiplicative hazards model with a calendar timeline. RESULTS: Our DM1 analysis included 911,648 individuals. Of 2613 DM1 cases identified, 338 remained in the analysis after applying our algorithm, HPV vaccine eligibility and membership criteria. Over the 10 years of the study period, comparing vaccinated with unvaccinated persons, we did not find an increased risk of DM1 associated with HPV vaccine receipt (hazard ratio 1.21, 95% Confidence Interval 0.94, 1.57). CONCLUSIONS: We found no increased risk for development of DM1 following HPV vaccination. Our study provides reassurance that during the 10-year time period after HPV vaccine was introduced, there was no substantial increased risk for DM1 following HPV vaccination.
Authors: C Chao; N P Klein; C M Velicer; L S Sy; J M Slezak; H Takhar; B Ackerson; T C Cheetham; J Hansen; K Deosaransingh; M Emery; K-L Liaw; S J Jacobsen Journal: J Intern Med Date: 2011-11-15 Impact factor: 8.989
Authors: L Grimaldi-Bensouda; D Guillemot; B Godeau; J Bénichou; C Lebrun-Frenay; C Papeix; P Labauge; P Berquin; A Penfornis; P-Y Benhamou; M Nicolino; A Simon; J-F Viallard; N Costedoat-Chalumeau; M-F Courcoux; C Pondarré; P Hilliquin; E Chatelus; V Foltz; S Guillaume; M Rossignol; L Abenhaim Journal: J Intern Med Date: 2013-11-22 Impact factor: 8.989
Authors: Nicola P Klein; Paula Ray; Diane Carpenter; John Hansen; Edwin Lewis; Bruce Fireman; Steven Black; Claudia Galindo; Johannes Schmidt; Roger Baxter Journal: Vaccine Date: 2009-11-05 Impact factor: 3.641
Authors: Nicola P Klein; John Hansen; Chun Chao; Christine Velicer; Michael Emery; Jeff Slezak; Ned Lewis; Kamala Deosaransingh; Lina Sy; Bradley Ackerson; T Craig Cheetham; Kai-Li Liaw; Harpreet Takhar; Steven J Jacobsen Journal: Arch Pediatr Adolesc Med Date: 2012-12
Authors: Julianne Gee; Allison Naleway; Irene Shui; James Baggs; Ruihua Yin; Rong Li; Martin Kulldorff; Edwin Lewis; Bruce Fireman; Matthew F Daley; Nicola P Klein; Eric S Weintraub Journal: Vaccine Date: 2011-09-09 Impact factor: 3.641
Authors: Lauri E Markowitz; Eileen F Dunne; Mona Saraiya; Herschel W Lawson; Harrell Chesson; Elizabeth R Unger Journal: MMWR Recomm Rep Date: 2007-03-23
Authors: Barbara A Slade; Laura Leidel; Claudia Vellozzi; Emily Jane Woo; Wei Hua; Andrea Sutherland; Hector S Izurieta; Robert Ball; Nancy Miller; M Miles Braun; Lauri E Markowitz; John Iskander Journal: JAMA Date: 2009-08-19 Impact factor: 56.272
Authors: Nadja Taumberger; Elmar A Joura; Marc Arbyn; Maria Kyrgiou; Jalid Sehouli; Murat Gultekin Journal: Int J Gynecol Cancer Date: 2022-07-12 Impact factor: 4.661