Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Primary Purpose
Cholera
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
killed whole cell oral cholera vaccine
Heat Killed E. coli
Sponsored by
About this trial
This is an interventional prevention trial for Cholera focused on measuring watery diarrhea, cholera vaccine
Eligibility Criteria
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
Sites / Locations
- National Institute of Cholera and Enteric Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Killed Whole Cell Oral Cholera Vaccine
Heat-killed E. coli
Outcomes
Primary Outcome Measures
adverse events
Secondary Outcome Measures
serum vibriocidal antibody response
Full Information
NCT ID
NCT00119197
First Posted
July 4, 2005
Last Updated
June 26, 2008
Sponsor
International Vaccine Institute
Collaborators
National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research, Shantha Biotechnics Limited
1. Study Identification
Unique Protocol Identification Number
NCT00119197
Brief Title
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Official Title
Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
International Vaccine Institute
Collaborators
National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research, Shantha Biotechnics Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera
Keywords
watery diarrhea, cholera vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Killed Whole Cell Oral Cholera Vaccine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Heat-killed E. coli
Intervention Type
Biological
Intervention Name(s)
killed whole cell oral cholera vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Heat Killed E. coli
Intervention Description
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
Primary Outcome Measure Information:
Title
adverse events
Time Frame
immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days
Secondary Outcome Measure Information:
Title
serum vibriocidal antibody response
Time Frame
baseline and 14 days after second dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujit K Bhatttacharya, MD
Organizational Affiliation
National Institute of Cholera and Enteric Diseases, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cholera and Enteric Diseases
City
Kolkata
State/Province
West Bengal
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
18523643
Citation
Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.
Results Reference
background
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Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
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