Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine
NCT ID: NCT00419133
Last Updated: 2009-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2007-06-30
2007-08-31
Brief Summary
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Detailed Description
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Phase II trials of this reformulated killed oral cholera vaccine were performed in SonLa, Vietnam and Kolkata, India. Significant vibriocidal antibody responses were observed among vaccine recipients.
Distribution of 2 doses of the cholera vaccine is often difficult in field settings and limits its utility in emergency situations, since an interval of 2 weeks is usually required between doses. Recent data from Vietnam suggests that greater vibriocidal responses following 2 doses are elicited compared to previous formulations. Furthermore, in a study in Bangladesh comparing immune responses to the vaccine among children supplemented with vitamin A and zinc, seroconversion after the first dose was robust in all groups suggesting that one dose may be used in the control of cholera.
Data regarding the immune response following one dose of this reformulated vaccine is currently unavailable. If a single dose of this vaccine is confirmed to be immunogenic to recipients, then this vaccine may be used more extensively for public health purposes, especially during times of outbreaks.
The objective of this study is to confirm the safety of the killed oral cholera vaccine among adult and children volunteers.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Cholera Vaccine
Killed bivalent whole cell oral cholera vaccine
Each 1.5 mL dose, given orally, contains:
V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS
2
Placebo
Heat Killed E. coli Placebo
Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
Interventions
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Killed bivalent whole cell oral cholera vaccine
Each 1.5 mL dose, given orally, contains:
V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS
Heat Killed E. coli Placebo
Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
Eligibility Criteria
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Inclusion Criteria
All subjects must satisfy the following criteria at study entry:
* Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)
* For females of reproductive age, they must not be pregnant (as determined by verbal screening)
* Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
* Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.
Exclusion Criteria
* Immunocompromising condition or therapy
* Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
* one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
* one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
* intake of any anti-diarrhoeal medicine in the past week
* abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
* acute disease one week prior to enrollment, with or without fever. Temperature \> or = 38 degrees C (oral) or axillary temperature \> or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject
* receipt of antibiotics in past 14 days
* receipt of live or killed enteric vaccine in last month
* receipt of killed oral cholear vaccine
1 Year
40 Years
ALL
Yes
Sponsors
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National Institute of Cholera and Enteric Diseases, India
OTHER
Shantha Biotechnics Limited
INDUSTRY
International Vaccine Institute
OTHER
Responsible Party
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International Vaccine Institute
Principal Investigators
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Sujit K Bhattacharya
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cholera and Enteric Diseases, India
Locations
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National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India
Countries
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References
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Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.
Other Identifiers
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C-8IR
Identifier Type: -
Identifier Source: org_study_id