Cholera
Conditions
Keywords
watery diarrhea, cholera vaccine
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.
Interventions
BIOLOGICALkilled 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
BIOLOGICALHeat 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
Sponsors
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Shantha Biotechnics Limited
International Vaccine Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events | immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days |
Secondary
| Measure | Time frame |
|---|---|
| serum vibriocidal antibody response | baseline and 14 days after second dose |
Countries
India
Outcome results
None listed