- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01524640
Bridging Study for Killed Oral Cholera Vaccine in Ethiopia
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Oromia
-
Addis Ababa, Oromia, Ethiopia
- Armauer Hansen Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Killed oral cholera vaccine
Killed Bivalent (O1 and O139) Whole cell oral cholera vaccine (Shanchol TM) Vaccine strain Reformulated version V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) of lipopolysaccharide (LPS) V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS |
1.5 ml single dose oral administration on day 0 and day 14
Other Names:
|
Placebo Comparator: Placebo
Non biologic placebo Ingredients Per 1.5 ml dose
All the above ingredients are of pharmaceutical grade. Non-biological placebo of above composition has been used in 2010 for "Randomized, double-blind, placebo controlled trial to evaluate the safety and immunogenicity of orally administered, killed, bivalent whole-cell , cholera vaccine, Shanchol in Bangladeshi Adults and Children". This study involving 330 subjects was carried out at International Center for Diarrheal Disease Research Bangladesh (ICDDR,B) located in Dhaka, Bangladesh with Dr. Firdausi Qadri as Principal Investigator (NCT01042951). There were no safety concerns associated with this placebo in this study and the report of this study has been submitted to the National Regulators in Bangladesh and the World Health Organization. |
1.5 ml oral administration on day 0 and day 14
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects given investigational product with adverse events.
Time Frame: 6 months
|
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 |
6 months
|
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.
Time Frame: 6 months
|
6 months
|
Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.
Time Frame: 6 months
|
6 months
|
Severe adverse event within 28 days following each dose of investigational product.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-WC-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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