Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine
NCT ID: NCT01508507
Last Updated: 2013-06-05
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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UNKNOWN
240 participants
OBSERVATIONAL
2013-03-31
2014-03-31
Brief Summary
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Detailed Description
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This study has following objectives
Primary objectives:
\* To evaluate the individual level protective effectiveness of one or two doses of OCV against culture confirmed cholera episodes, severe enough to seek a formal health care.
Secondary objectives:
* To evaluate population - level effectiveness (herd effects)of OCV delivered through a community based mass vaccination when the vaccine is delivered to more than half of population at risk.
* To determine inverse correlation between vaccine coverage and cholera incidence among diverse geographical clusters.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Cholera cases group
"Any diarrheal cases or suspected cholera cases from study area, whose stool specimen collected in study health center and examined in reference laboratory, reveals V. cholerae serotype O1/O139 is defined as cholera case"
No interventions assigned to this group
Control group
"A randomly selected age matched individual, who have been living in the study area and did not seek care for diarrheal illness in the study health center since vaccination is defined as control"
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Living in the study area since the start of the mass vaccination
* Submitted a faecal specimen
* Whose residence could be located
* Whose stool specimens yield V. cholera O1 or O139
* Belonging to study population through census database
Exclusion Criteria
* Not living in the study area since the start of the mass vaccination
* No faecal specimen
* Whose residence could not be located
* Whose stool specimens does not yield V. cholera O1 or O139
* Not belonging to study population through census database
1 Year
ALL
No
Sponsors
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Department of Health and Family Welfare, Orissa
OTHER
Regional Medical Research Center, Orissa
UNKNOWN
International Vaccine Institute
OTHER
Responsible Party
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Principal Investigators
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Shantanu K Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Director, Regional Medical Research Center, Bhubanewar, Orissa, India
Thomas F Wierzba, PHD
Role: PRINCIPAL_INVESTIGATOR
International Vaccine Institute
Locations
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Regional Medical Research Center
Chandrashekharpur, Bhubaneswar, Odisha, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009 Nov 14;374(9702):1694-702. doi: 10.1016/S0140-6736(09)61297-6. Epub 2009 Oct 8.
Anh DD, Canh DG, Lopez AL, Thiem VD, Long PT, Son NH, Deen J, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Holmgren J, Clemens J. Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults. Vaccine. 2007 Jan 22;25(6):1149-55. doi: 10.1016/j.vaccine.2006.09.049. Epub 2006 Sep 29.
Shin S, Desai SN, Sah BK, Clemens JD. Oral vaccines against cholera. Clin Infect Dis. 2011 Jun;52(11):1343-9. doi: 10.1093/cid/cir141. Epub 2011 Apr 14.
Other Identifiers
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CR-WC-10
Identifier Type: -
Identifier Source: org_study_id
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