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. 2019 Mar 28;37(14):1938-1944.
doi: 10.1016/j.vaccine.2019.02.051. Epub 2019 Mar 1.

Long term risk of developing type 1 diabetes after HPV vaccination in males and females

Nicola P Klein  1 , Kristin Goddard  2 , Edwin Lewis  2 , Pat Ross  2 , Julianne Gee  3 , Frank DeStefano  3 , Roger Baxter  2
Affiliations

Long term risk of developing type 1 diabetes after HPV vaccination in males and females

Nicola P Klein et al. Vaccine. .

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.

Keywords: DM1; Diabetes; HPV vaccine; Vaccine safety.

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Conflict of interest statement

Potential conflicts of interest

N.K. has received research support for unrelated studies from Sanofi Pasteur, GlaxoSmithKline, Pfizer, Merck, Protein Sciences (now Sanofi Pasteur), MedImmune and Dynavax. All other authors have no conflicts or financial disclosures.

Figures

Fig. 1.
Fig. 1.
Flow chart of DM1 case disposition, Kaiser Permanente Northern California (KPNC) 2006–2015.
Fig. 2.
Fig. 2.
Diabetes mellitus type I incidence by age and HPV vaccination status after applying lag period and membership criteria, Kaiser Permanente Northern California 2006–2015.
See this image and copyright information in PMC

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