A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children
This study is currently recruiting participants.
Verified November 2012 by International Vaccine Institute
Sponsor:
International Vaccine Institute
Collaborators:
Shantha Biotechnics Limited
Christian Medical College, Vellore, India
Information provided by (Responsible Party):
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00760825
First received: September 25, 2008
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine whether the killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™) is safe and effective in the treatment of Vibrio cholerae.
| Condition | Intervention | Phase |
|---|---|---|
|
Vibrio Cholerae |
Biological: killed bivalent (O1 and O139)whole cell oral cholera vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open Label Post Licensure Trial to Evaluate the Safety and Immunogenicity of Indigenously Manufactured Killed Bivalent (O1 and O139) Whole Cell Oral Cholera Vaccine(Shanchol™) |
Resource links provided by NLM:
Further study details as provided by International Vaccine Institute:
Primary Outcome Measures:
- Proportion of subjects with diarrhea [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies relative to baseline [ Time Frame: 14 days after each dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Geometric mean serum vibriocidal titers [ Time Frame: baseline and 14 days after each dose ] [ Designated as safety issue: No ]
- Proportion of subjects with any of the following adverse events: immediate reactions, serious adverse events, reactogenicity: headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, fever, loss of appetite, general ill feeling [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaccine
killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™)
|
Biological: killed bivalent (O1 and O139)whole cell oral cholera vaccine
1.5 ml given twice orally, 14 days apart
Other Name: Shanchol™
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female adults aged 18-40 years and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
- For females of reproductive age, they must not be pregnant (as determined by verbal screening).
- Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
- Healthy subjects as determined by: Medical history, Physical examination, Clinical judgment of the investigator
Exclusion Criteria:
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Diarrhea (3 or more loose/more watery stools within a 24-hour period) 6 weeks prior to enrollment
- One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- Intake of any anti-diarrhea medicine in the past week
- Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral) or axillary temperature ≥ 37.5ºC warrants deferral of the vaccination pending recovery of the subject
- Receipt of antibiotics in past 14 days
- Receipt of live or killed enteric vaccine in past 4 weeks
- Receipt of killed oral cholera vaccine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760825
Contacts
| Contact: Yanghee Kim, MPH | 82-2-881-1366 | yhkim@ivi.int |
| Contact: Binod Sah, MBBS, Msc | 82-2-881-1218 | bsah@ivi.int |
Locations
| India | |
| Christian Medical College | Recruiting |
| Vellore, Tamil Nadu, India, 632 002 | |
| Contact: Venkata R Mohan, M.D., MPH 91-41-6228-4207 venkat@cmcvellore.ac.in | |
| Contact: Gangadeep Kang, PhD 91-41-6307-2052 | |
| Sub-Investigator: Vinohar Balraj, MD | |
| Sub-Investigator: Jayaprakash Muliyil, PhD | |
Sponsors and Collaborators
International Vaccine Institute
Shantha Biotechnics Limited
Christian Medical College, Vellore, India
Investigators
| Principal Investigator: | Venkata R Mohan, M.D., MPH | Christian Medical College, Vellore, India |
More Information
No publications provided
| Responsible Party: | International Vaccine Institute |
| ClinicalTrials.gov Identifier: | NCT00760825 History of Changes |
| Other Study ID Numbers: | CH-WC-02 |
| Study First Received: | September 25, 2008 |
| Last Updated: | November 20, 2012 |
| Health Authority: | India: Drugs Controller General of India India: Institutional Review Board South Korea: Institutional Review Board |
Keywords provided by International Vaccine Institute:
|
cholera vibrios oral cholera vaccine |
Additional relevant MeSH terms:
|
Cholera Vibrio Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013