Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

International Vaccine Institute (IVI)

Status and phase

Completed

Phase 2

Conditions

Cholera

Treatments

Biological: killed whole cell oral cholera vaccine

Biological: Heat Killed E. coli

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00119197

C-8-ph2

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

12 months to 40 years old

Volunteers

Accepts Healthy Volunteers

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