Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
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.
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.
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