Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
|ClinicalTrials.gov Identifier: NCT00119197|
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : July 4, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cholera||Biological: killed whole cell oral cholera vaccine Biological: Heat Killed E. coli||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||July 2006|
Killed Whole Cell Oral Cholera Vaccine
Biological: killed whole cell oral cholera vaccine
Bivalent oral killed cholera vaccine: each dose of this vaccine contains:
each 1.5 mL dose given orally, two doses given 14 days apart
Placebo Comparator: 2
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
- 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 ]
- serum vibriocidal antibody response [ Time Frame: baseline and 14 days after second dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119197
|National Institute of Cholera and Enteric Diseases|
|Kolkata, West Bengal, India|
|Principal Investigator:||Sujit K Bhatttacharya, MD||National Institute of Cholera and Enteric Diseases, India|