Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by International Vaccine Institute
Sponsor:
Collaborators:
Department of Health and Family Welfare, Orissa
Regional Medical Research Center, Orissa
Information provided by (Responsible Party):
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT01508507
First received: December 14, 2011
Last updated: June 4, 2013
Last verified: June 2013
  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.


Condition
Cholera

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Vaccine protective effectiveness at individual level [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Matched controls will be selected among the persons of the same age group 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 questionaire interview for both 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.


Secondary Outcome Measures:
  • Population level effectiveness (herd effect) [ Time Frame: 11 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: 11 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 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: 240
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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"
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"

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508507

Contacts
Contact: Vijaya Laxmi Mogasale, MBBS, MD, DPH (Nut) +822 - 8811 442 VijayaLaxmi.Mogasale@ivi.int
Contact: Anuj Bhattachan, MBBS, MPH +822 - 8811 255 abhattachan@ivi.int

Locations
India
Regional Medical Research Center Recruiting
Chandrashekharpur, Bhubaneswar, Odisha, 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   
Sub-Investigator: Hemant K Khuntia, MBBS         
Sponsors and Collaborators
International Vaccine Institute
Department of Health and Family Welfare, Orissa
Regional Medical Research Center, Orissa
Investigators
Principal Investigator: Shantanu K Kar, MD Director, Regional Medical Research Center, Bhubanewar, Orissa, India
Principal Investigator: Thomas F Wierzba, PHD International Vaccine Institute
  More Information

Additional Information:
Publications:
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: June 4, 2013
Health Authority: India: Ministry of Health

Keywords provided by International Vaccine Institute:
Oral
Cholera
Vaccine
Herd
Risk
population
Matched
Control
Case
Bias

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014