HPV TYPE 16 VACCINE TRIAL IN COSTA RICA

哥斯达黎加 HPV 16 型疫苗试验

• 批准号: 8328345
• 负责人: ROLANDO HERRERO
• 金额: $ 423.67万
• 依托单位: FUNDACION INCIENSA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-30 至 2011-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8328345
• 关键词: Age; Antibodies; Antibody Avidity; Anus; Cervical; Cervix Uteri; Clinical; Clinical Trials Data Monitoring Committees; Collaborations; Communities; Costa Rica; Cytology; DNA; Dose; Drug Formulations; Effectiveness; Enrollment; Evaluation; Funding; Genetic Crossing Over; HPV-16/18 Vaccine; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papillomavirus 16; Individual; Infection; Institutional Review Boards; Lesion; Malignant neoplasm of cervix uteri; Measures; Medical; Natural History; Neoplasms; Oncogenic; Participant; Phase; Phase III Clinical Trials; Population; Premalignant; Randomized; Randomized Controlled Trials; Research; Safety; Screening procedure; Series; Serum; Site; Structural Protein; System; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Viral; Virion; Virus-like particle; Woman; Women' s Health; base; efficacy evaluation; follow-up; high risk; immunogenic; prevent; programs; prophylactic; response

Cervical cancer is one of the most common cancers among women worldwide. Approximately 500,000 new cases are diagnosed each year, resulting in over 200,000 deaths. Infection with one of a dozen or so oncogenic HPV types is now known to be the cause of nearly all cervical tumors, with two HPV types, HPV16 and HPV18, accounting for approximately 70% of the cases worldwide. Although cytological screening programs have been in place for several decades, these programs have not been effective at controlling cervical cancer in developing countries, where the vast majority of cervical cancer cases are diagnosed. Costa Rica was chosen for the Phase 3 trial because of our extensive successful scientific collaborations there, the high risk of cervical cancer, the universal medical system providing national linkage, and the likelihood of very high participation over the many needed years of close clinical follow-up. Randomization and 3-dose vaccination of 7,466 women enrolled into the HPV-16/18 Vaccine Trial in Costa Rica has been successfully completed. Women have been followed actively on an annual or semi-annual basis since enrollment. Women are now completing their first four years of follow-up in the trial and are being asked to enroll in the extended (up to 10 years) follow-up phase of the study. As women complete four years of active follow-up, cross-over vaccination is offered to trial participants. To date, the trial remains masked. Initial analyses focused on efficacy against virological outcomes are planned and the primary analysis of the prophylactic effect of this vaccine against histological endpoints is expected at the end of the first 4-years of follow-up. Evaluation of the therapeutic benefit of this vaccine has been completed. Results from the analysis indicate that the vaccine does not have any effect on clearance of HPV infections, when administered to women who already have an established infection. Thus, the vaccine should not be used to treat established infections and confers maximum benefit when administered to adolescents prior to sexual debut.

宫颈癌是世界上最常见的癌症之一。每年约有50万新病例被诊断出来，导致20多万人死亡。目前已知，几乎所有宫颈肿瘤都是由十几种致癌HPV类型中的一种感染引起的，其中两种HPV类型HPV 16和HPV 18占全球病例的约70%。虽然细胞学筛查计划已经实施了几十年，但这些计划在发展中国家控制宫颈癌方面并不有效，绝大多数宫颈癌病例都是在发展中国家诊断的。选择哥斯达黎加进行3期试验是因为我们在那里进行了广泛成功的科学合作，宫颈癌的高风险，提供国家联系的通用医疗系统，以及在需要多年密切临床随访的情况下参与率很高的可能性。哥斯达黎加HPV-16/18疫苗试验的7 466名妇女的随机化和3剂疫苗接种已成功完成。自入组以来，每年或每半年对妇女进行一次积极随访。女性现在正在完成他们在试验中的前四年随访，并被要求参加研究的延长（长达10年）随访阶段。当女性完成四年的积极随访时，为试验参与者提供交叉疫苗接种。到目前为止，审判仍然是秘密进行的。计划进行针对病毒学结局的有效性的初步分析，预计在前4年随访结束时进行该疫苗对组织学终点的预防作用的主要分析。该疫苗的治疗获益评价已完成。分析结果表明，当对已经感染的妇女接种疫苗时，疫苗对HPV感染的清除没有任何影响。因此，该疫苗不应用于治疗已建立的感染，并在首次性行为之前给予青少年时提供最大的益处。