Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Systemic Immunogenicity
研究概览
简要总结
The study will enroll approximately 60 volunteers. The vaccine is given as a drink in flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up.
Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study investigators nor the volunteers will know which group they are assigned.
Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing.
详细描述
The Phase 1 section of this study is a randomized double blind trial in which a total of 60 subjects (minimum of 52 allowable) will receive on of two oral vaccine doses according to the following chart:
Group Subset N CS6(Encapsulated) LT(R192G) I A 15 0.95mg 2 micrograms II B 15 0.95mg -- III A 15 0.95mg 2 micrograms IV B 15 0.95mg --
*minimum of 13 volunteers/group
Volunteers in Group I will receive three immunizations (study days 0, 14, and 28) during the vaccine series. Volunteers in Group II will receive four immunizations (study days 0, 2, 4, and 6) during the vaccine series. The two groups will be vaccinated separately for logistical purposes. Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively evaluated during vaccination and for 4 weeks following the final vaccine dose.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Available for required follow-up period
- •Women must have a negative pregnancy test
- •Women must not to try to become pregnant while on study and for 2 months after study is completed
排除标准
- •History of travellers' diarrhea
- •Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine
- •Regular use of anti-diarrheal, anti-constipation, or antacid therapy
- •Abnormal bowel habits
- •Pregnant or nursing women
- •History of chronic gastrointestinal illness or major gastrointestinal surgery
- •Allergies to vaccines
- •Positive HIV, Hepatitis B or Hepatitis C tests
- •Regular use of oral steroid medication
- •Clinically significant abnormalities on physical examination
结局指标
主要结局
Systemic Immunogenicity
Mucosal Immunogenicity
Safety
次要结局
未报告次要终点