NCT01508507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

December 14, 2011

Last Update Submit

June 4, 2013

Conditions

Cholera

Keywords

OralCholeraVaccineHerdRiskpopulationMatchedControlCaseBias

Outcome Measures

Primary Outcomes (1)

  • Vaccine protective effectiveness at individual level

    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.

    11 months

Secondary Outcomes (2)

  • Population level effectiveness (herd effect)

    11 months

  • Cohort / GIS study for the measure of herd protection

    11 months

Study Arms (2)

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"

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Medical Research Center

Chandrashekharpur, Bhubaneswar, Odisha, 751016, India

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18523643BACKGROUND

  • 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.

    PMID: 19819004BACKGROUND

  • 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.

    PMID: 17055622BACKGROUND

  • 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.

    PMID: 21498389BACKGROUND

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.

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Shantanu K Kar, MD

    Director, Regional Medical Research Center, Bhubanewar, Orissa, India

    PRINCIPAL INVESTIGATOR

  • Thomas F Wierzba, PHD

    International Vaccine Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vijaya Laxmi Mogasale, MBBS, MD, DPH (Nut)

CONTACT

+822 - 8811 442VijayaLaxmi.Mogasale@ivi.int

Anuj Bhattachan, MBBS, MPH

CONTACT

+822 - 8811 255abhattachan@ivi.int

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

January 12, 2012

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

IN(1)