Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

This study has been completed.
Sponsor:
Collaborators:
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Shantha Biotechnics Limited
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00119197
First received: July 4, 2005
Last updated: June 26, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Cholera
Biological: killed whole cell oral cholera vaccine
Biological: Heat Killed E. coli
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • serum vibriocidal antibody response [ Time Frame: baseline and 14 days after second dose ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: August 2005
Study Completion Date: July 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Killed Whole Cell Oral Cholera Vaccine
Biological: killed whole cell oral cholera vaccine

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

Placebo Comparator: 2
Heat-killed E. coli
Biological: Heat Killed E. coli

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


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.

  Eligibility

Ages Eligible for Study:   12 Months to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119197

Locations
India
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India
Sponsors and Collaborators
International Vaccine Institute
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Shantha Biotechnics Limited
Investigators
Principal Investigator: Sujit K Bhatttacharya, MD National Institute of Cholera and Enteric Diseases, India
  More Information

Publications:
Responsible Party: Director General, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00119197     History of Changes
Other Study ID Numbers: C-8-ph2
Study First Received: July 4, 2005
Last Updated: June 26, 2008
Health Authority: India: Ministry of Health

Keywords provided by International Vaccine Institute:
watery diarrhea
cholera vaccine

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014