Epidemiologic Impact of HPV Vaccination

HPV 疫苗的流行病学影响

• 批准号: 10227738
• 负责人: JESSICA A KAHN
• 金额: $ 61.56万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-18 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10227738
• 关键词: 15 year old; Address; Adherence; Age; Anogenital cancer; Area; Automobile Driving; Behavior; Behavioral Mechanisms; Biological; Cervical Cancer Screening; Clinic; Clinical; Clinical Trials; Communities; Cost Effectiveness Analysis; Counseling; Data; Data Set; Death Rate; Diagnostic; Dose; Effectiveness; Enrollment; Epidemiological trend; Epidemiology; Genotype; Goals; Healthy People 2020; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Individual; Infection; Infrastructure; Investigation; Longitudinal trends; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Marketing; Methodology; Methods; Morbidity - disease rate; Morphologic artifacts; Outcome; Policies; Population Heterogeneity; Prevalence; Public Health; Publications; Recommendation; Reporting; Research; Risk; Risk Reduction; Schedule; Screening for cancer; Seminal; Sentinel Surveillance; Signal Transduction; Time; Vaccinated; Vaccination; Vaccine Clinical Trial; Vaccines; Woman; Work; base; clinical practice; community setting; detection assay; disparity reduction; ethnic diversity; experience; health communication; high risk population; human female; inclusion criteria; innovation; male; malignant oropharynx neoplasm; men; mortality; non-compliance; novel; prevent; prophylactic; racial diversity; recruit; screening program; surveillance study; trend; vaccine effectiveness; virology; young man; young woman

Project Summary Introduction of prophylactic human papillomavirus (HPV) vaccines has the potential to dramatically decrease morbidity and mortality from anogenital and oropharyngeal cancers. However, data from vaccine clinical trials cannot predict vaccine effectiveness in “real-world” community settings, and introduction of a 9-valent (in addition to a 2- and 4-valent) vaccine in 2015 and reduced dosing schedules (from 3 to 2 doses) in 2016 could further modify vaccine effectiveness. The impact of vaccine introduction can be efficiently and accurately evaluated by HPV surveillance studies that assess vaccine effectiveness, herd protection, cross-protection (decrease in HPV types genetically related to vaccine types), and type replacement (increase in non-vaccine- type HPV due to a reduction in vaccine types). We previously conducted 4 HPV surveillance studies in women (2006-2017) and 2 in men (2013-2017). Among women, we found evidence for vaccine effectiveness (but lower effectiveness with 1 vs. 3 doses), herd protection, and cross-protection; no evidence for type- replacement; and an unexpected increase in non-vaccine-type HPV in unvaccinated women. Among men, we found preliminary evidence for vaccine effectiveness and herd protection. Continued investigation through the proposed renewal is essential to achieve the following objectives: 1) assess the effects of 9-valent vaccine introduction and reduced dosing schedules on effectiveness, 2) elucidate long-term trends in herd protection, 3) identify signals of diminished cross-protection or emerging type-replacement, and 4) determine mechanisms for increases in non-vaccine-type HPV in unvaccinated women. The specific aims are to: 1) determine long- term trends in 4-valent - and emerging trends in 9-valent - HPV prevalence among vaccinated women (2006- 2023) and men (2013-2023) to assess HPV vaccine effectiveness, and among unvaccinated women and men to assess herd protection; 2) assess the differential impact of the number of vaccine doses received on vaccine-type HPV, by age; 3) determine trends in non-vaccine-type HPV prevalence among vaccinated women and men, to examine for persistent cross-protection and emerging type replacement; and 3) explore biological and behavioral mechanisms for the increase in non-vaccine-type HPV in unvaccinated women. Our approach will be to enroll 1,600 women and men in two additional surveillance studies, to characterize the impact of vaccine introduction across a total of 6 time periods in women (2006-2023, N=2,400) and 4 in men (2013- 2023, N=1,600). The proposed research is innovative because the resulting data could shift current research and clinical practice paradigms in the areas of vaccination and virology, and the research plan utilizes novel concepts, approaches and new methodologies to explore mechanisms driving HPV trends. The proposed research is significant because the data will provide key evidence for: 1) vaccination and cervical cancer screening programs; 2) public health communications and risk-reduction counseling; and 3) cost-effectiveness analysis and policy decisions: these will help to reduce disparities and mortality due to HPV-related cancers.

项目摘要 引入预防性人乳头瘤病毒（HPV）疫苗有可能大大减少 肛门生殖器和口咽癌的发病率和死亡率。但是，来自疫苗临床试验的数据 无法预测“现实世界”社区环境中的疫苗有效性，并引入了9个价值（在 除了2015年增加2和4价）疫苗，并减少了2016年的给药时间表（从3剂量）减少 进一步修改疫苗有效性。疫苗引入的影响可以有效，准确 通过HPV监视研究评估，评估疫苗有效性，保护群，交叉保护 （减少与疫苗类型相关的HPV类型）和类型替代品（增加非疫苗 由于疫苗类型的减少，类型HPV）。我们以前在女性中进行了4项HPV监视研究 （2006-2017）和男性2（2013-2017）。在妇女中，我们发现了疫苗有效性的证据（但是 较低的有效性，1剂3剂），保护和交叉保护；没有类型的证据 替代品;在未接种疫苗的妇女中，非疫苗类型的HPV意外增加。在男人中，我们 找到了疫苗有效性和畜群保护的初步证据。继续调查 提出的续约对于实现以下目标至关重要：1）评估9值疫苗的影响 介绍和减少了有效性的给药时间表，2）阐明牛群保护的长期趋势， 3）确定交叉保护或新兴类型替换的信号，4）确定机制 为了增加未接种妇女的非疫苗类型HPV。具体目的是：1）确定长期 接种疫苗的妇女的4价值和新兴趋势的期限趋势（2006-- 2023年）和男性（2013-2023）评估HPV疫苗有效性，在未接种疫苗的男女中 评估牛群保护； 2）评估接收疫苗剂量数量的差异影响 疫苗型HPV，按年龄； 3）确定接种妇女的非疫苗类型HPV患病率的趋势 和男人，检查持续的交叉保护和新兴类型的替代品； 3）探索生物学 和行为机制，用于未接种疫苗的妇女中非疫苗类型HPV的增加。我们的方法 将在另外两项监视研究中注册1,600名男女，以表征 女性总共6个时间段的疫苗引入（2006-2023，n = 2,400），男性4（2013-- 2023，n = 1,600）。拟议的研究具有创新性，因为结果数据可能会改变当前的研究 以及疫苗接种和病毒学领域的临床实践范例，研究计划利用了新颖 探索驱动HPV趋势的机制的概念，方法和新方法。提议 研究很重要，因为数据将提供：1）疫苗接种和宫颈癌。 筛选计划； 2）公共卫生通信和降低风险咨询； 3）成本效益 分析和政策决策：这些将有助于减少与HPV相关的癌症引起的分布和死亡率。