Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

NCT00119197 | Completed Phase 2 DMC

• 1 other identifier: C-8-ph2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholera

Keywords

watery diarrhea; cholera vaccine

Outcome Measures

Primary Outcomes (1)

• adverse events

  immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days

Secondary Outcomes (1)

• serum vibriocidal antibody response

  baseline and 14 days after second dose

Study Arms (2)

1

EXPERIMENTAL

Killed Whole Cell Oral Cholera Vaccine

Biological: killed whole cell oral cholera vaccine

2

PLACEBO COMPARATOR

Heat-killed E. coli

Biological: Heat Killed E. coli

Interventions

killed whole cell oral cholera vaccine 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

1

Heat Killed E. coli 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

2

Eligibility Criteria

• Age: 12 Months - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years

You may not qualify if:

• 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• National Institute of Cholera and Enteric Diseases, India: collaborator
• Indian Council of Medical Research: collaborator
• Shantha Biotechnics Limited: collaborator

Study Sites (1)

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Location

Related Publications (1)

• 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.

  PMID: 18523643 BACKGROUND

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sujit K Bhatttacharya, MD

  National Institute of Cholera and Enteric Diseases, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2005
• First Posted: July 13, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 4, 2008

Record last verified: 2008-06

Locations

IN (1)