A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
研究概览
简要总结
This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.
The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.
The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.
详细描述
Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the subject prior to enrolment;
- •Female between, and including, 18 and 25 years of age at the time of enrolment;
- •Subjects must be free of obvious health problems;
- •Not pregnant and having no plan for pregnancy;
排除标准
- •Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
- •Previous vaccination against HPV;
- •Having severe allergic history or other immunodeficiency;
- •Chemotherapy and other immunosuppressive agents using;
结局指标
主要结局
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
时间窗: 7 months
To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.
次要结局
- Number of Participants with Adverse Events(7 months)
研究者
Jun Zhang
professor
Xiamen University