Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine

Cholera Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01508507
• Other study ID #: CR-WC-10
• Status: Unknown status
• Phase: N/A
• First received: December 14, 2011
• Last updated: June 4, 2013
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2013
• Source: International Vaccine Institute
• Contact: Vijaya Laxmi Mogasale, MBBS, MD, DPH (Nut)
• Phone: +822 - 8811 442
• Email: VijayaLaxmi.Mogasale[@]ivi.int
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 240
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Cholera

Locations

Country	Name	City	State
India	Regional Medical Research Center	Chandrashekharpur, Bhubaneswar	Odisha

Sponsors (3)

Lead Sponsor	Collaborator
International Vaccine Institute	Department of Health and Family Welfare, Orissa, Regional Medical Research Center, Orissa

Country where clinical trial is conducted

India, 

References & Publications (4)

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. Epub 2006 Sep 29. — View 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. — View 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. Review. — View 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. Erratum in: Lancet. 2010 Oct 23;376(9750):1392. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Population level effectiveness (herd effect)	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.	11 months
Secondary	Cohort / GIS study for the measure of herd protection	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.	11 months

External Links

•   The International Vaccine Institute (IVI) is an international nonprofit organization that was founded on the belief that the health of children in developing countries can be dramatically improved by the use of new and improved vaccines.