Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

Cholera Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119197
• Other study ID #: C-8-ph2
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2005
• Last updated: June 26, 2008
• Start date: August 2005
• Est. completion date: July 2006

Study information

• Verified date: June 2008
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cholera

Intervention

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
• 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

Locations

Country	Name	City	State
India	National Institute of Cholera and Enteric Diseases	Kolkata	West Bengal

Sponsors (4)

Lead Sponsor	Collaborator
International Vaccine Institute	Indian Council of Medical Research, National Institute of Cholera and Enteric Diseases, India, Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events		immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days	Yes
Secondary	serum vibriocidal antibody response		baseline and 14 days after second dose	No