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)
研究组 & 干预措施
Vaccine to past vaccinated participants
The first arm includes subjects, who were immunized with two Shanchol™ doses, five years prior. In this study, arm one will receive one Shanchol™ booster dose at baseline and one booster dose on day fourteen.
干预措施: Shanchol™, oral cholera vaccine (Biological)
No intervention to past placebo recipients
The third arm includes subjects, who received two placebo doses, five years prior. This third arm will not receive any intervention and will serve to represent a baseline immune response by vaccine naïve individuals exposed to natural exposure.
干预措施: no intervention (Other)
Vaccine to past placebo recipients
The second arm includes subjects, who received two placebo doses, five years prior. Arm two will receive a primary immunization series consisting of one Shanchol™ dose at baseline and one at day fourteen
干预措施: Shanchol™, killed, whole cell, bivalent, oral cholera vaccine (Biological)
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