Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cholera	Biological: killed whole cell oral cholera vaccine Biological: Heat Killed E. coli	Phase II

ChemIDplus related topics:

Cholera Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Official Title:	Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal

Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:

adverse events [ Time Frame: immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

serum vibriocidal antibody response [ Time Frame: baseline and 14 days after second dose ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	August 2005
Study Completion Date:	July 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Killed Whole Cell Oral Cholera Vaccine	Biological: 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
2: Placebo Comparator Heat-killed E. coli	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

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

Ages Eligible for Study:	12 Months to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119197

Locations


India, West Bengal
	National Institute of Cholera and Enteric Diseases
	Kolkata, West Bengal, India

Sponsors and Collaborators

International Vaccine Institute

National Institute of Cholera and Enteric Diseases, India

Indian Council of Medical Research

Shantha Biotechnics Limited

Investigators


Principal Investigator:	Sujit K Bhatttacharya, MD	National Institute of Cholera and Enteric Diseases, India

More Information

Publications:

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.

Responsible Party:	International Vaccine Institute ( Director General )
Study ID Numbers:	C-8-ph2
First Received:	July 4, 2005
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00119197
Health Authority:	India: Ministry of Health

Keywords provided by International Vaccine Institute:

watery diarrhea

cholera vaccine

Study placed in the following topic categories:

Bacterial Infections

Diarrhea

Vibrio Infections

Cholera

Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	International Vaccine Institute National Institute of Cholera and Enteric Diseases, India Indian Council of Medical Research Shantha Biotechnics Limited
Information provided by:	International Vaccine Institute
ClinicalTrials.gov Identifier:	NCT00119197