HUMAN PAPILLOMAVIRUS (HPV) TYPE 16 VACCINE TRIAL IN COSTA RICA

哥斯达黎加进行人乳头瘤病毒 (HPV) 16 型疫苗试验

• 批准号: 8654867
• 负责人: ANA CECILIA RODRIGUEZ
• 金额: $ 228.03万
• 依托单位: FUNDACION INCIENSA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8654867
• 关键词: Age; Antibodies; Anus; Cervical; Cervix Uteri; Clinical; Collaborations; Colposcopy; Communities; Costa Rica; Cytology; DNA; Dose; Drug Formulations; Effectiveness; Enrollment; Evaluation; Funding; Genetic Crossing Over; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Individual; Infection; Lesion; Malignant neoplasm of cervix uteri; Medical; Natural History; Neoplasms; Oncogenic; Oral cavity; Participant; Phase; Phase III Clinical Trials; Population; Pregnancy; Pregnancy Rate; Premalignant; Randomized; Randomized Controlled Trials; Research; Safety; Series; Serum; Site; Structural Protein; System; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Virion; Virus-like particle; Woman; Women' s Health; base; efficacy evaluation; follow-up; high risk; immunogenic; prevent; programs; prophylactic; response; screening; young adult

To evaluate the safety, efficacy, and population effectiveness/impact of a virus-like particle human papillomavirus vaccine over a 10-year period. This will include an evaluation of efficacy against HPV types not included in the vaccine formulation, efficacy observed when fewer than three doses are administered, and a proof-of principle evaluation of efficacy at extracervical sites. To explore immunological responses associated with vaccination, immunological determinants of protection, and minimum protective levels associated with vaccination. To evaluate the impact of HPV vaccination on cytology and HPV DNA based screening programs. To evaluate the natural history of HPV types other than HPV-16/18 in a vaccinated population.

评估病毒样颗粒人乳头瘤病毒疫苗在10年内的安全性、有效性和人群有效性/影响。这将包括对疫苗配方中未包括的HPV类型的疗效评估，当接种少于三剂时观察到的有效性，以及对宫颈外部位有效性的原则证明评估。探讨与接种疫苗相关的免疫学反应、保护的免疫学决定因素以及与接种疫苗相关的最低保护水平。评估接种HPV疫苗对细胞学和HPVDNA筛查程序的影响。评估接种人群中HPV-16/18以外的其他HPV类型的自然病史。