CholeraNCT01508507
Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine
An observational study of Cholera, run by International Vaccine Institute at 1 site in India.
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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Regional Medical Research Center
Chandrashekharpur, Bhubaneswar, Odisha, 751016
Shantanu K Kar, MD, 91-674-301322, rmrcdir@sancharnet.in
Anna S Kerketta, MBBS, 91-674-2301387, solani_bara@rediffmail.com
About this study
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
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.
Read the 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.
- Conditions
- Cholera
- Keywords
- Oral, Cholera, Vaccine, Herd, Risk, population, Matched, Control, Case, Bias
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 months
Secondary outcomes (2)
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.
Measured: 11 months
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.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMar 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Family Welfare, Orissa, Regional Medical Research Center, Orissa
- Responsible party
- Sponsor
- Investigators
- Shantanu K Kar, MD, Principal investigator, Director, Regional Medical Research Center, Bhubanewar, Orissa, IndiaThomas F Wierzba, PHD, Principal investigator, International Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508507
- Sponsor's protocol ID
- CR-WC-10
- Status last verified
- Jun 2013
- First submitted
- 14 Dec 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18523643Sur 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.
PubMed 19819004Anh 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.
PubMed 17055622Shin 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.
PubMed 21498389
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01508507
- Acronym / sponsor ID
- CR-WC-10
- Conditions
- Cholera
- Keywords
- Oral, Cholera, Vaccine, Herd, Risk, population, Matched, Control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Department of Health and Family Welfare, Orissa, Regional Medical Research Center, Orissa
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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" |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccine protective effectiveness at individual level
Time frame: 11 months
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.
2 secondary outcomes
Population level effectiveness (herd effect)
Time frame: 11 months
Cohort / GIS study for the measure of herd protection
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Background: PubMed 18523643Mahalanabis 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.
- Background: PubMed 19819004Sur 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.
- Background: PubMed 17055622Anh 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.
- Background: PubMed 21498389Shin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shantanu K Kar, MD principal investigator
Director, Regional Medical Research Center, Bhubanewar, Orissa, India
Thomas F Wierzba, PHD principal investigator
International Vaccine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholera, run by International Vaccine Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vijaya Laxmi Mogasale, MBBS, MD, DPH (Nut) (+822 - 8811 442, VijayaLaxmi.Mogasale@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine protective effectiveness at individual level (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508507, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.