Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

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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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

adverse events

Secondary Outcome

 serum vibriocidal antibody response

Condition

Cholera

Intervention

killed whole cell oral cholera vaccine

Study Arms / Comparison Groups

 1
Description:  Killed Whole Cell Oral Cholera Vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

200

Start Date

August 2005

Completion Date

July 2006

Primary Completion Date

June 2006

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

Gender

All

Ages

12 Months - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sujit K Bhatttacharya, MD, ,

Location Countries

India

Location Countries

India

Administrative Informations

NCT ID

NCT00119197

Organization ID

C-8-ph2

Study Sponsor

International Vaccine Institute

Collaborators

 National Institute of Cholera and Enteric Diseases, India

Study Sponsor

Sujit K Bhatttacharya, MD, Principal Investigator, National Institute of Cholera and Enteric Diseases, India

Verification Date

June 2008