Oliveira Carlos R, Ortiz Anette Michelle, Sheth Sangini S, Shapiro Eugene D, Niccolai Linda M
Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA
Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.
BMJ Open. 2021 Apr 19;11(4):e043093. doi: 10.1136/bmjopen-2020-043093.
In 2006, the first human papillomavirus (HPV) vaccine was approved by the Food and Drug Administration in the USA based on pre-licensure clinical trials that found it to be highly efficacious at preventing persistent infection and precancerous, high-grade cervical lesions (HGCLs) caused by viral types the vaccine protects against. However, the real-world effectiveness of HPV vaccines as used in clinical practice may be quite different from the efficacy found in pre-licensure clinical trials. More than 10 years have passed since the introduction of the vaccine programme. It is critical to determine if the full benefits of HPV are being realised in real-world settings.
The objectives of this study were to estimate the effectiveness of HPV vaccines as used in real-world clinical settings and to determine the degree to which the vaccine's effectiveness varies based on age at the time of immunisation and the number of doses received. The study will be a population-based, matched case-control study. Cases will be women with newly diagnosed HGCL associated with HPV types 16 and 18. Matched controls will be women with a normal Pap test result, matched individually to cases in a 2:1 ratio by age, a practice and date of testing. Medical records will be reviewed to determine dates of receipt of the HPV vaccine for all participants. We will use multivariate conditional logistic regression to control for potential confounders.
This protocol presents minimal risk to the subjects. This protocol has received approval from the Institutional Review Board of Yale University (HIC: 1502015308), and a Health Insurance Portability and Accountability Act (HIPAA) Waiver of Authorisation has been granted to allow investigators to recruit subjects for the study. Findings will be disseminated through peer-reviewed, open-access scientific journals and conference presentations.
2006年，美国食品药品监督管理局批准了首款人乳头瘤病毒（HPV）疫苗，其依据的是许可前临床试验，该试验发现该疫苗在预防由疫苗所针对的病毒类型引起的持续感染以及癌前高级别宫颈病变（HGCLs）方面具有高效性。然而，HPV疫苗在临床实践中的实际效果可能与许可前临床试验中发现的疗效有很大不同。自疫苗计划推出以来已过去10多年。确定在实际环境中是否能充分实现HPV疫苗的益处至关重要。
本研究的目的是评估HPV疫苗在实际临床环境中的有效性，并确定疫苗有效性随免疫时年龄和接种剂量数的变化程度。该研究将是一项基于人群的匹配病例对照研究。病例将是新诊断出与16型和18型HPV相关的HGCL的女性。匹配的对照将是巴氏试验结果正常的女性，按年龄、医疗机构和检测日期以2:1的比例与病例进行个体匹配。将审查医疗记录以确定所有参与者接种HPV疫苗的日期。我们将使用多变量条件逻辑回归来控制潜在的混杂因素。
本方案对受试者的风险极小。本方案已获得耶鲁大学机构审查委员会（HIC：1502015308）的批准，并已获得《健康保险流通与责任法案》（HIPAA）授权豁免，允许研究人员招募研究对象。研究结果将通过同行评审的开放获取科学期刊和会议报告进行传播。
