Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine
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Purpose
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.
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Cholera |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| 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 |
- Vaccine protective effectiveness at individual level [ Time Frame: 6 months ] [ Designated as safety issue: No ]Matched controls will be selected among the persons of the same age group, gender, and residence as that of each case. 1 to 4 ratio will be used in matching cases to controls.Information on all other exposure variables will be collected through an inperson interview with cases and controls. "Protective effectiveness (PE) (%) = [1- the odds of vaccination among cholera confirmed cases relative to the odds of vaccination among matched controls] × 100" is the metric to measure vaccine protective effectiveness at individual level.
- Population level effectiveness (herd effect) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Indirect effect: Fraction of household members who are vaccinated in households of unvaccinated cases compared with fraction of household members who are vaccinated in households of unvaccinated controls
Total effect: Fraction of household members who are vaccinated in households of vaccinated cases compared with the fraction of household members who are vaccinated in households of vaccinated controls.
Overall effects: Fraction of household members who are vaccinated in household of cases compared with fraction of household members who are vaccinated in control households.
- Cohort / GIS study for the measure of herd protection [ Time Frame: 6 months ] [ Designated as safety issue: No ]Geographic unit as a cluster for evaluating vaccine herd protection with the use of cohort analysis, using GIS information from the baseline census. Here, there will be comparison in the incidence of the target outcome (cholera or non-cholera diarrhea) according to the level of vaccine coverage of the geographic unit.
Biospecimen Retention: Samples Without DNA
Rectal swabs will be collected from all cases and control that fulfills inclusion criteria. It will be plated directly into TCBS agar as well as after enrichment in APW for 6 to 20 hours (pH 8.6, 37 degree centrigrade). After this overnight incubation, suspected colonies from TCBS will be tested biochemically and agglutinated with polyvalent, Ogawa and Inaba antisera. Biotyping of O1 isolates will be done with chicken erythrocyte agglunitation tests and determination of polymyxin sensitivity. Non - agglunating strains will be tested with antiserum to V cholarae O139 strain. V cholarae isolates will be tested for susceptibility to the following antimicrobials: tetracycline, erythromycin, furazolidin, trimithprim - sulfame thoxale, ciprofloxacin and norfloxacin.
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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cholera cases group
It is defined as "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 cholera case".
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Controls group
It is defined as,"A randomly selected age, sex and village/hamlet matched individuals, who have been living in the study area and did not seek care for diarrheal illness in the study health center since vaccination."
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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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
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
Contacts and Locations| Contact: Binod Sah, MBBS, MS | +822 - 8811 218 | bsah@ivi.int |
| India | |
| Regional Medical Research Center | Not yet recruiting |
| Chandrashekharpur, Bhubaneswar, Orissa, India, 751016 | |
| Contact: Shantanu K Kar, MD 91-674-301322 rmrcdir@sancharnet.in | |
| Contact: Anna S Kerketta, MBBS 91-674-2301387 solani_bara@rediffmail.com | |
| Principal Investigator: | Shantanu K Kar, MD | Director, Regional Medical Research Center, Bhubanewar, Orissa, India |
| Principal Investigator: | Sunheang Shin, PHD | International Vaccine Institute |
More Information
No publications provided
| Responsible Party: | International Vaccine Institute |
| ClinicalTrials.gov Identifier: | NCT01508507 History of Changes |
| Other Study ID Numbers: | CR-WC-10 |
| Study First Received: | December 14, 2011 |
| Last Updated: | November 5, 2012 |
| Health Authority: | India: Ministry of Health |
Keywords provided by International Vaccine Institute:
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Oral Cholera Vaccine Herd Risk |
population Matched Control Case Bias |
Additional relevant MeSH terms:
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Cholera Vibrio Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013