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Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128011
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : November 10, 2006
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
Göteborg University
Information provided by:
International Vaccine Institute

Tracking Information
First Submitted Date  ICMJE August 8, 2005
First Posted Date  ICMJE August 9, 2005
Last Update Posted Date November 10, 2006
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
  • Adverse events
  • Serum Vibriocidal antibody response
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine
Official Title  ICMJE A Safety and Immunogenicity Study of a New Formulation of the Locally-Produced Bivalent Killed, Whole-Cell Oral Cholera Vaccine in Vietnamese Subjects
Brief Summary The purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among Vietnamese adults.
Detailed Description Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnam’s public health programs. A 2-dose regimen of this vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages over the existing Swedish vaccine. It confers protection against the El Tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. However, this vaccine is not licensed for use in countries other than Vietnam. In order to make this vaccine available to other countries, the IVI has provided technical assistance to produce this vaccine following the WHO Good Manufacturing Practices standards. A new formulation of the current oral cholera vaccine was produced following these guidelines. Since this vaccine is slightly different from the previous vaccine, a study is necessary to demonstrate safety and immunogenicity for local licensure and larger Phase III studies in other countries.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Cholera
Intervention  ICMJE Biological: killed oral cholera vaccine
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 8, 2005)
150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy non-pregnant adults
  • Available in the study area for 1 month

Exclusion Criteria:

  • Diarrhea for the past week
  • Antibiotic use in the past week
  • Intake of anti-diarrheal medicines in the past week
  • One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
  • Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128011
Other Study ID Numbers  ICMJE C-12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE International Vaccine Institute
Collaborators  ICMJE
  • National Institute of Hygiene and Epidemiology, Vietnam
  • Göteborg University
Investigators  ICMJE
Principal Investigator: Dang Duc Anh, PhD National Institute of Hygiene and Epidemiology, Vietnam
PRS Account International Vaccine Institute
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP