A study to evaluate safety and immunogenicity of Shanchol (Killed Bivalent Whole cell Oral Cholera Vaccine) in Adults and Children.
- Registration Number
- CTRI/2012/01/002354
- Lead Sponsor
- INTERNATIONAL VACCINE INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Healthy adults aged from 18-40 years and healthy children aged 1-17 years.All subjects must satisfy the following criteria at study entry:
1)Healthy Male or Female adult volunteers aged 18-40 years and children 1-17 years who the investigator believes will comply with the requirement of the study protocol
2)Non Pregnant females of reproductive age.
3)Written informed consent obtained from the subject or their parents/guardians ,and written assent for children aged 12-17 years
4)Healthy subjects as determined by:
oMedical history
oPhysical examination
oClinical judgment of the investigator
The following criteria should be checked at the time of study entry,if any of the following is present then the subject will be excluded from the study:
1)Ongoing serious chronic disease
2)Immunocompromising condition or therapy
3)Diarrhea (3 or more loose/more watery stools within a 24 hour period) 6 weeks prior to enrollment
4)One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
5)One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
6)Intake of any anti-diarrhea medicine in the past week
7)Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
8)Acute disease one week prior to enrollment, with or without fever. Temperature 38°c (oral) or axillary temperature 37.5°c warrants deferral of the vaccination pending recovery of the subject
9)Receipt of antibiotics in past 14 days
10)Receipt of live or killed enteric vaccine in past 4 weeks
11)Receipt of killed oral cholera vaccine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Safety: Proportion of subjects with diarrhea <br/ ><br>2)Immunogenicity: Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline,14 days after the first dose of vaccine and 14 days after the second dose of vaccine. <br/ ><br>Timepoint: 14 days after the first dose of vaccine and 14 days after the second dose of vaccine. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Geometric mean serum vibriocidal titers at baseline, 14 days after dose 1, and 14 days after dose 2 of killed oral cholera vaccine (Shanchol)Timepoint: 14 days after dose 1, and 14 days after dose 2 of killed oral cholera