Clinical trial NCT01508507: Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine
Official title: Effectiveness of a Bivalent, Killed Whole-cell Based Oral Cholera Vaccine(Shanchol®) Delivered Through Community-based Mass Vaccination Campaign in a High-risk Population in India: Matched Case-control Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholera
Keywords: Oral
Cholera
Vaccine
Herd
Risk
population
Matched
Control
Case
Bias
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: Department of Health and Family Welfare, Orissa
name: Regional Medical Research Center, Orissa
First posted: 2012-01-12
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The same population of Satyabadi block, Puri, Orissa, where Pilot introduction of Oral Cholera Vaccine (OCV) was conducted during May - June, 2011. During this campaign, the OCV vaccine was delivered through community based mass vaccination utilizing public health system.

Brief summary: Various field studies has found that the modified , bivalent, whole cell - based oral cholera vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in earlier clinical trials. However, the effectiveness of the vaccine in "real" life situation using the public health system is unknown. It is critical to follow up in the same population, where pilot introduction of OCV was introduced and evaluate vaccine proactive effectiveness at individual as well as at population level. The follow - up and determination of effectiveness of mass OCV vaccination was requested by State Government.

Detailed description: The overall goal of this study is to evaluate the protective effectiveness of one or two doses of modified, bivalent, killed whole cell based OCV, given at least 14 days apart, when delivered through community - based mass vaccination campaign using existing public health infrastructure in a high - risk population in Satyabadi block of Puri district, Orissa, India.

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.

Eligibility criteria: Inclusion criteria for cases of the main case-control study are as follows:

* Giving verbal informed consent/assent, or in the case of minors, a parent or guardian give informed consent to participate in the study
* 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 giving verbal informed consent/assent, or in the case of minors, a parent or guardian does not give informed consent to participate in the study
* 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

Primary outcomes:
measure: Vaccine protective effectiveness at individual level
timeFrame: 11 months
Secondary outcomes:
measure: Population level effectiveness (herd effect)
timeFrame: 11 months
measure: Cohort / GIS study for the measure of herd protection
timeFrame: 11 months
Other outcomes:
Locations:
city: Chandrashekharpur, Bhubaneswar
country: India
facility: Regional Medical Research Center
state: Odisha
Study officials:
affiliation: Director, Regional Medical Research Center, Bhubanewar, Orissa, India
name: Shantanu K Kar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Vaccine Institute
name: Thomas F Wierzba, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.