Phase I/II, Randomized, Observer-blind, Placebo-controlled, Single-Center Study of the Tolerability, Immunogenicity, and Efficacy of an Novartis' Investigational H. Pylori Vaccine in H. Pylori-Negative Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
研究概览
简要总结
To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults 18 - 40 years of age in good health
- •HP uninfected
- •not pregnant and agree to use birth control throughout the study (females who can become pregnant)
排除标准
- •remote or current HP infection
结局指标
主要结局
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
时间窗: 12 weeks post HP challenge
The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo). Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT).
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
时间窗: Day 1-7 post vaccination
To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local\* and systemic adverse events.
次要结局
- Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.(12 months)
- Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge(12 weeks post HP challenge)
- The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups(12 months)
- Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)(12 weeks post HP challenge)
- The Geometric Mean Concentrations After HP Vaccination.(upto 1 month after 3rd vaccination)