IGF::OT::IGF TASK ORDER 1: ONE-DOSE TRIAL SETUP, ENROLLMENT AND IMMUNIZATION

IGF::OT::IGF 任务顺序 1：一剂试验设置、注册和免疫接种

• 批准号: 9576431
• 负责人: PAULA GONZALEZ
• 金额: $ 2093.99万
• 依托单位: FUNDACION INCIENSA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9576431
• 关键词: Antibody Response; Antibody titer measurement; Contracts; Costa Rica; Dose; Enrollment; HPV-16/18 Vaccine; Human Papilloma Virus Vaccine; Immunization; Participant; Public Health; Regimen; Woman; cohort; follow-up; prophylactic; vaccine efficacy; vaccine trial

This objective of this contract is to support a new trial aimed at evaluating the non-inferiority of 1 versus 2 doses of the HPV vaccines and an additional extension to the follow-up of women in NCI’s ongoing Costa Rica Vaccine Trial (CVT) (which initially followed women for 10 years and will now extend that follow up out to 15 years among a subset of participants). CVT showed similar HPV vaccine efficacy over four years among women who received one, two and three doses of the HPV16/18 vaccine, and stable antibody responses have been observed throughout the seven years of follow-up accrued to date in CVT. Following up on these discoveries and further documenting the protection afforded by fewer doses could result in a monumental, global public health breakthrough.

该合同的目的是支持一项新的试验，旨在评估1剂与2剂HPV疫苗的非劣效性，并对NCI正在进行的哥斯达黎加疫苗试验（CVT）中的女性随访进行额外扩展（最初对女性进行了10年随访，现在将在一部分参与者中将随访延长至15年）。CVT在接受一剂、两剂和三剂HPV 16/18疫苗的妇女中显示出相似的HPV疫苗效力，并且在CVT迄今为止的7年随访中观察到稳定的抗体应答。跟进这些发现并进一步记录更少剂量所提供的保护可能会导致巨大的全球公共卫生突破。