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 Among 9-11 Year-old Girls and Boys
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
研究概览
简要总结
Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.
详细描述
PRIMARY OBJECTIVES:
I. To determine the persistence and stability of serologic geometric mean titer (GMT) of HPV 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose.
SECONDARY OBJECTIVES:
I. To determine the persistence and stability of serologic GMT of HPV types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose.
II. To assess safety and reactogenicity to each vaccine dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, medically well girls and boys
- •Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant
- •Ability to understand and the willingness to sign a written assent document by the participant
排除标准
- •Previous vaccination against HPV
- •The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product
- •Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
- •Receiving active treatment for cancer or an autoimmune condition
- •Confirmed or suspected immunosuppressive or immunodeficient condition
- •Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy
- •Are pregnant
研究组 & 干预措施
Prevention (Gardasil 9)
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
Prevention (Gardasil 9)
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
时间窗: Between 6 and 24 months after prime dose and prior to the administration of the second dose
Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
次要结局
- Vaccine Reactogenicity(Up to 30 months)
- Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11(Data are not available. The study team is working on analyzing the antibody titers of other HPV types.)
- Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0(Up to 2 weeks post-treatment)