Clinical trial NCT00119197: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholera
Keywords: watery diarrhea
cholera vaccine
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Cholera and Enteric Diseases, India
name: Indian Council of Medical Research
name: Shantha Biotechnics Limited
First posted: 2005-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: adverse events
timeFrame: immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days
Secondary outcomes:
measure: serum vibriocidal antibody response
timeFrame: baseline and 14 days after second dose
Other outcomes:
Locations:
city: Kolkata
country: India
facility: National Institute of Cholera and Enteric Diseases
state: West Bengal
Study officials:
affiliation: National Institute of Cholera and Enteric Diseases, India
name: Sujit K Bhatttacharya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.