Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

This study has been completed.
Sponsor:
Collaborators:
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
First received: July 4, 2005
Last updated: June 26, 2008
Last verified: June 2008

July 4, 2005
June 26, 2008
August 2005
June 2006   (final data collection date for primary outcome measure)
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 ]
  • adverse events
  • serum vibriocidal antibody response
Complete list of historical versions of study NCT00119197 on ClinicalTrials.gov Archive Site
serum vibriocidal antibody response [ Time Frame: baseline and 14 days after second dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cholera
  • 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

  • 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

  • Experimental: 1
    Killed Whole Cell Oral Cholera Vaccine
    Intervention: Biological: killed whole cell oral cholera vaccine
  • Placebo Comparator: 2
    Heat-killed E. coli
    Intervention: Biological: Heat Killed E. coli
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
12 Months to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00119197
C-8-ph2
Yes
Director General, International Vaccine Institute
International Vaccine Institute
  • National Institute of Cholera and Enteric Diseases, India
  • Indian Council of Medical Research
  • Shantha Biotechnics Limited
Principal Investigator: Sujit K Bhatttacharya, MD National Institute of Cholera and Enteric Diseases, India
International Vaccine Institute
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP