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

疫苗接种后。

• 批准号: 8309179
• 负责人: DAVID H ADLER
• 金额: $ 12.54万
• 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 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8309179
• 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; next generation; novel vaccines; patient oriented research; public health relevance; response; sexually active; vaccination strategy; young man; young woman

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）：建议开展一个有指导的、以患者为导向的研究项目，为候选人提供严格的培训和研究人乳头瘤病毒（HPV）疫苗引入的病毒学效应的经验。针对 HPV 16 和 18 型的新疫苗的影响尚不确定。尽管所有宫颈癌都是由 HPV 引起，但 16 型和 18 型（即疫苗类型）仅占病例的 65-70%。其余 30-35% 的病例由另外 13-16 种 HPV 类型引起。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 类型的患病率将因接种 16 型和 18 型疫苗而发生变化。如果得到证实，这将表明非疫苗 HPV 类型导致宫颈癌的发病率将发生变化。疫苗接种后的变化。考虑到宫颈癌在全球造成的巨大负担，了解这种新的预防干预措施如何影响该疾病是一个重要的公共卫生问题。拟议的研究将作为欧洲资助的南非大型项目的子研究进行。拟议项目的三个具体目标是：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) 确定并比较疫苗接种前和接种后的分布南非 HIV 感染者和未感染 HIV 性活跃的年轻女性中 HR-HPV 的患病率，以及 3) 分析研究人群中子宫颈发育不良与 HPV DNA 分析结果的关联。 拟议项目的基本设计是一项纵向队列研究，其中性活跃的年轻女性将接受 HPV DNA 检测、接种疫苗，然后每隔六个月重新检测 HPV。我们研究人群中的 HIV 阳性亚组将受到特别关注，因为这种广泛流行的共病可能会影响 HPV 分布和疫苗反应。所有研究参与者将在研究入组和退出时进行子宫颈抹片检查，以了解 HPV 感染与宫颈疾病的相关性。 该候选人的职业目标包括成为发展中国家传染病预防领域的知名独立调查员。执行提议的项目将使候选人为实现这一目标做好准备。 公共卫生相关性：项目叙述/相关性 了解针对某些类型的致癌 HPV 的疫苗接种如何影响许多其他类型的致癌 HPV 的分布对于预测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“针对哪种 HPV 类型的疫苗接种将挽救最多女性生命？”这一问题。