PRISMA AND EXTEND 2.0 FOLLOW-UP OF STUDY PARTICIPANTS

PRISMA 和 EXTEND 2.0 研究参与者的跟进

• 批准号: 10933669
• 负责人: BRYON ROMERO
• 金额: $ 11万
• 依托单位: FUNDACION INCIENSA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10933669
• 关键词: 14 year old; Antibody Response; Antibody titer measurement; Blinded; Blood; Cancer Burden; Cervical; Cervical Cancer Screening; Collection; Communities; Costa Rica; Development; Diagnostic; Dose; Eligibility Determination; Enzyme-Linked Immunosorbent Assay; Exposure to; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Human papillomavirus 18; Infection; Licensure; Malignant neoplasm of cervix uteri; Manuals; Participant; Phase; Prevention Research; Procedures; Public Health; Randomized Controlled Clinical Trials; Training; Update; Vaccination; Visit; Woman; aged; cervical cancer prevention; chronic infection; follow-up; girls; novel; premalignant; prisma; prophylactic; randomized, clinical trials; screening; unvaccinated; vaccine trial

Human papillomavirus (HPV) infection is necessary for the development of cervical cancer. Worldwide, infection with HPV types 16 and 18 account for approximately 70% of cervical cancer cases. Cervical cancer could be nearly eliminated as a public health problem if prophylactic HPV vaccination and cervical cancer screening with effective diagnostic follow up and treatment of cervical precancers were deployed globally. Yet, less than 10% of young girls receive HPV vaccination and similarly low proportion of women receive cervical cancer screening globally. Consequently, cervical cancer burden is expected to increase over the coming century despite the 2018 WHO call for cervical cancer elimination as a public health problem. NCI continues to push forward cervical cancer prevention research on both HPV vaccination and screening. PRISMA PRISMA is a randomized, controlled clinical trial of 5000 women aged 18-30 years to quantitate the reduction in incident cervical HPV16/18 persistent infections afforded by a single dose of the bivalent and nonavalent HPV vaccines compared to no vaccination, the default standard in the majority of the world for women over the age of 14 years. In FY23, the window for the first 12-month follow-up visit opened, study forms and manuals were updated, and staff were trained in the follow-up procedures. EXTEND2.0: The Costa Rica HPV Vaccine Trial (CVT) was a community-based, pre-licensure, randomized clinical trial, to evaluate the VLP-based, bivalent HPV vaccine. One of the more unexpected and novel discoveries showed that, in a post-hoc analysis, protection over four years against HPV16/18 infections among women initially uninfected with these types was uniformly high for recipients of one, two, or three doses after four years of follow-up in the blinded phase of the CVT. Among women who received a single dose, HPV16 and HPV18 antibody titers (assessed by ELISA) were substantially higher than those among unvaccinated women previously exposed to HPV16/18; titers remained stably elevated from 6-to-48 months post-vaccination, albeit at lower levels than for two or three doses. We initially extended CVT to 7 and 9 years; and further extended the effort for two additional visits from 991 women at years 14 and 16 (EXTEND). The current study, EXTEND2.0, is for two more visits from 693 women at years 18 and 20. We aim to describe, by dose, the long-term positivity and stability of the antibody response to HPV vaccination. In FY23, the window for the 18-year follow-up visit opened. Nearly 60% of the eligible women attended the visit with high compliance with blood collection (100%).

人乳头瘤病毒（HPV）感染是宫颈癌发生的必要条件。在世界范围内，HPV 16 型和 18 型感染约占宫颈癌病例的 70%。如果在全球范围内部署预防性 HPV 疫苗接种和宫颈癌筛查，并进行有效的诊断随访和宫颈癌前期治疗，那么宫颈癌作为一个公共卫生问题几乎可以消除。然而，全球只有不到 10% 的年轻女孩接受了 HPV 疫苗接种，而接受宫颈癌筛查的女性比例也同样较低。因此，尽管 2018 年世界卫生组织呼吁将消除宫颈癌作为一个公共卫生问题，但预计未来一个世纪宫颈癌负担将增加。 NCI 继续推进 HPV 疫苗接种和筛查方面的宫颈癌预防研究。 棱镜 PRISMA 是一项对 5000 名 18-30 岁女性进行的随机对照临床试验，旨在量化单剂量二价和非价 HPV 疫苗与不接种疫苗相比，宫颈 HPV16/18 持续感染事件的减少情况，这是世界上大多数 14 岁以上女性的默认标准。 2023 财年，开启了第一个 12 个月随访窗口，更新了研究表格和手册，并对工作人员进行了随访程序培训。 扩展2.0： 哥斯达黎加 HPV 疫苗试验 (CVT) 是一项基于社区的预许可随机临床试验，旨在评估基于 VLP 的二价 HPV 疫苗。一项更出人意料且新颖的发现表明，在一项事后分析中，在 CVT 盲期随访四年后，最初未感染 HPV16/18 类型的女性中，接受一剂、两剂或三剂的女性在四年内对 HPV16/18 感染的保护作用一致较高。在接受单剂​​疫苗的女性中，HPV16 和 HPV18 抗体滴度（通过 ELISA 评估）显着高于之前接触过 HPV16/18 的未接种疫苗的女性；接种后 6 至 48 个月内，滴度保持稳定升高，但低于两剂或三剂的水平。我们最初将CVT延长至7年和9年；并进一步扩大努力，在 14 岁和 16 岁的时候对 991 名女性进行两次额外的访问（EXTEND）。目前的研究 EXTEND2.0 对 693 名 18 岁和 20 岁女性进行了两次随访。我们的目的是通过剂量描述 HPV 疫苗接种抗体反应的长期阳性和稳定性。 23财年，18年跟踪访问的窗口打开了。近 60% 的符合条件的女性参加了此次访视，并且对采血的依从性很高（100%）。