A Randomized, Double-blind, Controlled Trial to Evaluate the Safety and Immunogenicity of Killed Bivalent (o1 and o139) Whole-cell Based Oral Cholera Vaccine (Shanchol®) in Healthy Individuals in Ethiopia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.
研究概览
简要总结
This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.
详细描述
This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the bivalent killed oral cholera vaccine may be used safely among those who are most at risk for cholera, we need to determine the safety and immunogenicity of the killed oral cholera vaccine. The vaccine was evaluated in a large number of human subjects in India Vietnam, and Bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective efficacy. Though we do not expect the vaccine to act differently in the Ethiopian population, we aim to confirm our presumptive understanding that two doses of WC-OCV is safe and immunogenic in healthy volunteers at one year and above (exclusive of pregnant women). Findings from this study can pave the way for the possible use of the killed whole cell oral cholera vaccine in both endemic and outbreak settings at a larger scale.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection.
- •The subject should be able to continue in the study for the next 4 weeks
- •The subject (or parent/guardian) should be willing to provide 3 blood samples
- •For females of reproductive age, non-pregnant (as determined by urine pregnancy test).
- •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
- •Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
- •Ongoing acute illness.
- •For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
- •Immunocompromising condition or on chronic systemic steroid therapy
- •Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
- •Intake of any anti-diarrhea medicine in the past week
- •Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
- •Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
- •Previous hypersensitivity to formaldehyde.
- •Receipt of immunoglobulin or any blood product during the past 3 months
- •Receipt of oral cholera vaccine in the past three years
- •Any potential subject currently participating or who will participate within the next six months in another clinical trial
- •Positive screening urine pregnancy test for females greater than 12 years of age
结局指标
主要结局
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.
时间窗: 6 months
Proportion of subjects given investigational product with adverse events.
时间窗: 6 months
1. Immediate reactions within 30 minutes after each dose 2. Serious Adverse Events occurring 14 days following each dose 3. Reactogenicity: Headache, vomiting, nausea, abdominal pain/cramps, diarrhea, fever, loss of appetite within three days i. Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period. ii. Fever is defined as having an oral or axillary temperature of ≥ 38oC
次要结局
- Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.(6 months)
- Severe adverse event within 28 days following each dose of investigational product.(6 months)
- Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.(6 months)