A Open Labeled Controlled Trial to Evaluate the Immune Response of a Boosting Regimen With Shanchol™, a Killed Whole Cell Oral Cholera Vaccine (WC-OCV), in Previously Immunized Adults and Children in Eastern Kolkata, India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Immunogenicity provided by a two dose boosting regimen of Shanchol™
研究概览
简要总结
Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial 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
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:
- •Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.
- •The subject should be able to continue in the study for the next 6 weeks
- •The subject (or parent/guardian) should be willing to provide 3 blood samples
- •Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
- •Healthy subjects as determined by:
- •Medical history
- •Physical examination
- •Clinical judgment of the investigator
排除标准
- •individuals who are too weak to get out of bed to receive the vaccine
- •pregnant women (identified through verbal screening)
- •those less than 6 years of age
- •Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)
结局指标
主要结局
Immunogenicity provided by a two dose boosting regimen of Shanchol™
时间窗: 28 days
To determine whether two doses of Shanchol™ administered to a previously immunized cohort elicits similar immune responses (greater than fourfold rise in serum vibriocidal antibody titers through IgM) to those achieved by a primary immunization series in an unimmunized cohort stratified by age (6-14 and ≥15 years old),
次要结局
- Immunogenicity provided by a one dose boosting regimen of Shanchol™(28 days)
- Rises in serum IgA and IgG following boosting regimens(28 days)
- Proportion of subjects with adverse events(42 days)
研究者
Sachin Desai
ASSOCIATE RESEARCH SCIENTIST
International Vaccine Institute