Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

NCT ID: NCT00119197

Last Updated: 2008-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-07-31

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.

Conditions

Cholera

Keywords

watery diarrhea; cholera vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Killed Whole Cell Oral Cholera Vaccine

Group Type: EXPERIMENTAL

killed whole cell oral cholera vaccine

Intervention Type: BIOLOGICAL

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

2

Heat-killed E. coli

Group Type: PLACEBO_COMPARATOR

Heat Killed E. coli

Intervention Type: BIOLOGICAL

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

Interventions

killed 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

Intervention Type: BIOLOGICAL

Heat 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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Cholera and Enteric Diseases, India

OTHER

Sponsor Role: collaborator

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Shantha Biotechnics Limited

INDUSTRY

Sponsor Role: collaborator

International Vaccine Institute

OTHER

Sponsor Role: lead

Responsible Party

International Vaccine Institute

Principal Investigators

Sujit K Bhatttacharya, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cholera and Enteric Diseases, India

Locations

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 18523643 (View on PubMed)

Other Identifiers

C-8-ph2

Identifier Type: -

Identifier Source: org_study_id