Department of Public Health Sciences (Liu, Lévesque), Queen's University, Kingston, Ont.; Department of Epidemiology, Biostatistics and Occupational Health (Smith), McGill University, Montréal, Que. Division of Allergy and Immunology, Department of Medicine (Ellis), Queen's University, Kingston, Ont.; Allergy Research Unit (Ellis), Kingston General Hospital, Kingston, Ont.; School of Mathematics and Statistics (Whitaker, Farrington), The Open University, Milton Keynes, UK; Vaccine Safety Section, Centre for Immunization and Respiratory Infectious Diseases (Law [retired from the Public Health Agency of Canada June 2015]), Public Health Agency of Canada, Ottawa, Ont.; Institute for Clinical Evaluative Sciences (Kwong, Lévesque), Toronto, Ont.; Public Health Ontario (Kwong), Toronto, Ont.; Department of Family and Community Medicine (Kwong), University of Toronto, Toronto, Ont.; Leslie Dan Faculty of Pharmacy (Lévesque), University of Toronto, Toronto, Ont.
CMAJ. 2018 May 28;190(21):E648-E655. doi: 10.1503/cmaj.170871.
BACKGROUND: Despite demonstrated effectiveness in real-world settings, concerns persist regarding the safety of the quadrivalent human papillomavirus (HPV4) vaccine. We sought to assess the risk of autoimmune disorders following HPV4 vaccination among grade 8 girls eligible for Ontario's school-based HPV vaccination program. METHODS: We undertook a population-based retrospective cohort study using Ontario's administrative health and vaccination databases from 2007 to 2013. The self-controlled case series method was used to compare the rate of a composite end point of autoimmune disorders diagnosed during days 7-60 post-vaccination ("exposed" follow-up) to that at any other time ("unexposed"). The analysis was repeated to assess the effect of a history of immune-mediated diseases and time since vaccination. We also conducted an exploratory analysis of individual autoimmune disorders. Rate ratios and 95% confidence intervals (CIs) were estimated using conditional Poisson regression, adjusted for age, seasonality, concomitant vaccinations and infections. RESULTS: The study cohort consisted of 290 939 girls aged 12-17 years who were eligible for vaccination between 2007 and 2013. There was no significant risk for developing an autoimmune disorder following HPV4 vaccination ( = 681; rate ratio 1.12, 95% CI 0.85-1.47), and the association was unchanged by a history of immune-mediated disorders and time since vaccination. Exploratory analyses of individual autoimmune disorders found no significant risks, including for Bell palsy ( = 65; rate ratio 1.73, 95% CI 0.77-3.89), optic neuritis ( = 67; rate ratio 1.57, 95% CI 0.74-3.33) and Graves disease ( = 47; rate ratio 1.55, 95% CI 0.92-2.63). INTERPRETATION: We did not observe an increased risk of autoimmune disorders following HPV4 vaccination among teenaged girls. These findings should reassure parents and health care providers.
背景：尽管在真实环境中已证实其有效性，但人们对四价人乳头瘤病毒（HPV4）疫苗的安全性仍存在担忧。我们旨在评估安大略省基于学校的 HPV 疫苗接种计划中符合条件的 8 年级女孩接种 HPV4 疫苗后发生自身免疫性疾病的风险。
方法：我们利用安大略省 2007 年至 2013 年的行政健康和疫苗接种数据库开展了一项基于人群的回顾性队列研究。采用自身对照病例系列法比较接种后 7-60 天内（“暴露”随访）复合自身免疫性疾病终点的发生率与任何其他时间（“未暴露”）的发生率。重复该分析以评估既往免疫介导性疾病史和接种时间的影响。我们还对个体自身免疫性疾病进行了探索性分析。使用条件泊松回归估计率比和 95%置信区间（CI），并根据年龄、季节性、同时接种疫苗和感染情况进行调整。
结果：研究队列包括 290939 名 12-17 岁有资格接种疫苗的女孩，她们于 2007 年至 2013 年期间接种疫苗。接种 HPV4 疫苗后发生自身免疫性疾病的风险无显著升高（=681；率比 1.12，95%CI 0.85-1.47），且该关联不受既往免疫介导性疾病和接种时间的影响。对个体自身免疫性疾病的探索性分析发现无显著风险，包括贝尔麻痹（=65；率比 1.73，95%CI 0.77-3.89）、视神经炎（=67；率比 1.57，95%CI 0.74-3.33）和格雷夫斯病（=47；率比 1.55，95%CI 0.92-2.63）。
结论：我们未观察到少女接种 HPV4 疫苗后自身免疫性疾病的风险增加。这些发现应使家长和医疗保健提供者安心。
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