A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children

This study has been completed.
Sponsor:
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: June 16, 2014
Last verified: June 2014
  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 ]

Enrollment: 200
Study Start Date: March 2012
Study Completion Date: August 2013
Primary Completion Date: April 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:

  1. 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).
  2. For females of reproductive age, they must not be pregnant (as determined by verbal screening).
  3. Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
  4. Healthy subjects as determined by: Medical history, Physical examination, Clinical judgment of the investigator

Exclusion Criteria:

  1. Ongoing serious chronic disease
  2. Immunocompromising condition or therapy
  3. Diarrhea (3 or more loose/more watery stools within a 24-hour period) 6 weeks prior to enrollment
  4. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
  5. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
  6. Intake of any anti-diarrhea medicine in the past week
  7. Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
  8. 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
  9. Receipt of antibiotics in past 14 days
  10. Receipt of live or killed enteric vaccine in past 4 weeks
  11. Receipt of killed oral cholera vaccine
  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: NCT00760825

Locations
India
Christian Medical College
Vellore, Tamil Nadu, India, 632 002
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: June 16, 2014
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 September 15, 2014