Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

Study Overview
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Brief Summary
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The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.

Detailed Description
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Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages over the existing Swedish vaccine. It confers protection against the El Tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. However, this vaccine is not licensed for use in countries other than Vietnam. Through IVI, an agreement between VABIOTECH in Hanoi and Shantha Biotechnics PVT, LTD in India has been reached that will make the bivalent vaccine available in India. A double-blind randomized phase III trial in a cholera-endemic area would be necessary to demonstrate the efficacy of this vaccine in other settings. This would pave the way for the introduction of the vaccine into the national immunization programme in India and the internationalization of this vaccine and licensure in other countries where it is needed. Prior to the phase III trial, a phase II study will be performed among adults and children.

Official Title
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Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal

Conditions
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Cholera

Intervention / Treatment
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* Biological: killed whole cell oral cholera vaccine
* Biological: Heat Killed E. coli


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years Exclusion Criteria: Diarrhea during the past week Antibiotic and anti-diarrheal medicine use during the past week One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours Pregnancy

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Killed Whole Cell Oral Cholera Vaccine | Biological: killed whole cell oral cholera vaccine<br>* Bivalent oral killed cholera vaccine: each dose of this vaccine contains: Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells Inactivated V.Cholerae O139 - 50.109 cells each 1.5 mL dose given orally, two doses given 14 days apart<br>|
| Placebo Comparator: 2<br>Heat-killed E. coli | Biological: Heat Killed E. coli<br>* Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine. Each 1.5 mL dose given orally, two doses given 14 days apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum vibriocidal antibody response |  | baseline and 14 days after second dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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watery diarrhea, cholera vaccine