Post-Vacc. HPV Genotype Distr. Among HIV+ and HIV- Young Women in S. Africa

疫苗接种后。

• 批准号: 8134482
• 负责人: DAVID H ADLER
• 金额: $ 12.56万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8134482
• 关键词: Accounting; Address; Adolescent; Affect; Africa; Automobile Driving; Cancer Etiology; Cervical; Cervical dysplasia; Clinical Trials; Cohort Studies; Communicable Diseases; Comorbidity; Controlled Study; DNA; DNA analysis; Developing Countries; Development; Disease; Drug Formulations; Enrollment; Epidemiologic Studies; European; Funding; Future; Genotype; Goals; Grant; HIV; HIV Seropositivity; HIV prevention trial; HIV vaccine; HPV-High Risk; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Incidence; Knowledge; Malignant neoplasm of cervix uteri; Mentors; Oncogenic; Pap smear; Participant; Population; Population Study; Prevalence; Preventive Intervention; Proxy; Public Health; Relative (related person); Research Personnel; Research Project Grants; Site; South Africa; Specimen; Subgroup; Testing; Training; Vaccinated; Vaccination; Vaccines; Western World; Woman; base; career; control trial; design; disorder prevention; experience; men; next generation; novel vaccines; patient oriented research; public health relevance; response; sexually active; vaccination strategy

DESCRIPTION (provided by applicant): A mentored, patient-oriented, research project is proposed to provide the candidate with rigorous training and experience in studying the virologic effects of human papillomavirus (HPV) vaccine introduction. The impact of the new vaccines against HPV types 16 and 18 is uncertain. Although all cervical cancer is caused by HPVs, types 16 and 18 (i.e. the vaccine types) account for only 65-70% of cases. An additional 13-16 HPV types cause the remaining 30-35% of cases. The proposed study will assess the impact of the HPV 16/18 vaccine on the other oncogenic HPV types. The primary hypothesis of the study is that the prevalence of vaccine and non-vaccine HPV types will change as a result of vaccination against types 16 and 18. If confirmed, this would indicate that the incidence of cervical cancer from non-vaccine HPV types will change in the wake of vaccination. Considering the staggering global burden of cervical cancer, understanding how this new preventive intervention impacts the disease is a critical public health concern. The proposed study will be carried out as a sub-study within a larger European-funded project in South Africa. The three specific aims of the proposed project are: 1) To assess the impact of the quadrivalent HPV vaccine on the distribution of non-vaccine HR-HPV in the study population, 2) To determine and compare the pre- and post-vaccination distribution of HR-HPV among HIV-infected and HIV-uninfected sexually active young women in South Africa, and 3) To analyze the association of cervical dysplasia with the results of HPV DNA analysis in the study population. The fundamental design of the proposed project is a longitudinal cohort study in which sexually active young women will be tested for HPV DNA, vaccinated, and then re-tested for HPV at six month intervals. The HIV positive subgroup within our study population will receive special focus as this widely prevalent co-morbidity may effect HPV distribution and vaccine response. Pap smears of all study participants will be performed upon study enrolment and exit to enable correlation of HPV infection with cervical disease. The candidate's career goals include becoming an established, independent investigator of infectious disease prevention in the developing world. Executing the proposed project will prepare the candidate to accomplish this goal. PUBLIC HEALTH RELEVANCE: Project Narrative/Relevance Understanding how vaccination against some types of cancer-causing HPVs affects the distribution of the many other types of cancer-causing HPVs is essential to anticipating the impact of vaccination on reducing cervical cancer. During the development of the next generation of HPV vaccines, knowledge gained from the proposed project will directly address the question, "Vaccination against which HPV types will save the most women's lives?".

描述（由申请人提供）：提出了一个指导的，面向患者的研究项目，旨在为候选人提供严格的培训和研究人乳头瘤病毒（HPV）疫苗介绍的病毒学作用的经验。新疫苗对HPV类型16和18的影响尚不确定。尽管所有宫颈癌都是由HPV引起的，但类型16和18（即疫苗类型）仅占病例的65-70％。另外的13-16 HPV类型导致剩余的30-35％的病例。拟议的研究将评估HPV 16/18疫苗对其他致癌HPV类型的影响。 该研究的主要假设是，疫苗和非疫苗HPV类型的患病率会因针对16和18型的疫苗接种而发生变化。疫苗接种后的变化。考虑到宫颈癌的全球负担惊人的负担，了解这种新的预防性干预如何影响该疾病是一个至关重要的公共卫生问题。拟议的研究将在南非一个较大的欧洲资助项目中作为一个子研究。拟议项目的三个具体目的是：1）评估四价HPV疫苗对研究人群中非疫苗HR-HPV分布的影响，2）确定和比较疫苗前和后接种后分布的分布和比较。在南非，HIV感染和HIV未感染的性活跃的年轻女性中的HR-HPV和3）分析研究人群中HPV DNA分析的结果，分析宫颈发育不良的关联。 拟议项目的基本设计是一项纵向队列研究，在该研究中，将对性活跃的年轻女性进行HPV DNA测试，接种疫苗，然后以六个月的间隔重新测试HPV。我们研究人群中的HIV阳性亚组将受到特殊重点，因为这种广泛普遍的合并症可能会影响HPV分布和疫苗反应。所有研究参与者的子宫颈抹片检查将在研究入学和退出后进行，以使HPV感染与宫颈疾病相关。 候选人的职业目标包括成为发展中国家的既定，独立的传染病预防研究者。执行拟议的项目将为候选人做好准备以实现这一目标。 公共卫生相关性：项目叙事/相关性了解对某些类型的引起癌症的HPV的疫苗接种如何影响许多其他类型的引起癌症的HPV的分布对于预期疫苗接种对减少宫颈癌的影响至关重要。在下一代HPV疫苗的开发过程中，从拟议项目中获得的知识将直接解决以下问题：“疫苗接种哪种HPV类型可以挽救最多的妇女生命？”。