A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-RANDOMIZED, PHASE IIA TRIAL OF A NONAVALENT PROPHYLACTIC HPV VACCINE TO ASSESS IMMUNOGENICITY OF A PRIME AND DEFERRED-BOOSTER DOSING SCHEDULE

对非有效预防性 HPV 疫苗进行前瞻性、单臂、开放标签、非随机、IIA 期试验，以评估初免和延迟加强剂量方案的免疫原性

• 批准号: 9981475
• 负责人: SHERRY CHOW
• 金额: $ 13.97万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9981475
• 关键词: 12 year old; Clinical Trials; Dose; Enrollment; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papillomavirus 16; Immune response; Intervention; Phase; Safety; Schedule; Serological; United States; Vaccination; Vaccines; Visit; arm; follow-up; girls; immunogenicity; open label; prophylactic; prospective

The proposed clinical trial will evaluate if a prime dose of the nonavalent HPV vaccine induces persistent and stable immune responses in 9-12 year old girls in the United States over 18 months post-vaccination follow-up period, before deferred booster doses are administered. It will be a prospective, single-arm, open-label, non-randomized, phase IIA trial that will assess immunogenicity of the prime and deferred-booster dosing schedule of the nonavalent prophylactic HPV vaccine among 9-12 year-old girls. A concurrent reference group of 9-12 year old girls receiving a standard dose schedule of the vaccine will also be enrolled for secondary comparison of the immune responses.

拟议的临床试验将评估九价HPV疫苗的初始剂量是否在接种后18个月的随访期内在美国9-12岁的女孩中诱导持久和稳定的免疫应答，然后再给予延期的加强剂量。 这将是一项前瞻性、单臂、开放标签、非随机、IIA期试验，将评估9-12岁女孩中九价预防性HPV疫苗的初免和延迟-加强给药方案的免疫原性。还将入组接受标准疫苗给药方案的9-12岁女孩的同期参考组，以进行免疫应答的二次比较。