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	Vaccine: killed oral cholera vaccine	Phase II

Further Study Details: 

Primary Outcomes: adverse events; serum vibriocidal antibody response
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  12 Months   -   40 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00119197

Jacqueline L Deen, MD      +82-2-881-1128    jdeen@ivi.int
Anna L Lopez, MD      +82-2-881-1129    anlopez@ivi.int

India, West Bengal
      National Institute of Cholera and Enteric Diseases, Kolkata,  West Bengal,  India

Study chairs or principal investigators

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

Study ID Numbers:  C-8-ph2
Record last reviewed:  July 2005
Last Updated:  July 18, 2005
Record first received:  July 12, 2005
ClinicalTrials.gov Identifier:  NCT00119197
Health Authority: India: India''''s Drug Controller General, a division of the Ministry of Health
ClinicalTrials.gov processed this record on 2005-07-26