Trial record 13 of 14 for:    Open Studies | "Cholera"

Field Application of Shanchol in Adults in Bangladesh

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01762930
First received: October 16, 2012
Last updated: April 2, 2014
Last verified: August 2012
  Purpose

Background:

Cholera is a public health problem globally and in Bangladesh and its prevention is important. Despite recent availability of an effective and affordable oral cholera vaccine (OCV), its field application remains a challenge and needs to be addressed in carefully conducted research studies.There is lack of information on temperature sensitivity and resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses of OCVs, one month apart, instead of currently recommended 14 days, to improve success of vaccination programme will be effective;also if one dose of the vaccine, instead of currently recommended two doses, would result in adequate immune response in population exposed to V. cholerae in an endemic country like Bangladesh.

Objectives:

To determine immunogenicity of Shanchol in adults. when:

  1. the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days, before putting back in cold box for administration in the field and compare them with the response when the vaccine is stored under currently recommended temperatures.
  2. two doses of the vaccine administered one month apart and compared vaccines administered at currently recommended interval of 14 days.
  3. a single dose is administered and compare them with responses after recommended two doses.

Methods: The study will be conducted among adults living in the Mirpur community in urban Dhaka, the capital of Bangladesh.Studying safety and acute and long-term immune responses over a period of one year.

Outcome measures/variables:

  1. Objective 1: safety and immunogenicity of vaccine in adults after its storage at three defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses and compare them with the findings when the vaccine is stored at currently recommended temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).
  2. Objective 2: compare vibriocidal responses following administration of two doses of the vaccine one month apart and compare them with vaccination 14 days apart over a period of one year, with study of the memory responses over a one year period as a secondary outcome.
  3. Objective 3: compare acute immune responses (vibriocidal antibody) following one and two doses of vaccine, and compare memory response as a secondary outcome measure, over a one year period.

The above information is needed urgently for developing effective vaccination strategies for prevention and control of cholera in endemic countries.


Condition Intervention Phase
Other Specified Effects of Reduced Temperature
Drug: Shanchol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Study of Field Application of Oral Cholera Vaccine, Shanchol for Use in Developing Country Settings

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Immunogenicity of Shanchol cholera vaccine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Immunogenicity of Shanchol vaccine will be measured by vibriocidal response in adults storing the vaccine at 2-8 0 c, 25 oC, 37 oC and 42oC


Secondary Outcome Measures:
  • Immunogenicity by vibriocidal response [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Vibriocidal responses following administration of two doses of the vaccine will be measured one month apart and 14 days apart with study of memory responses

  • Acute and memory B and T cell responses [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Acute and memory B and T cell responses following administration of one and two doses of Shanchol vaccine will be measured


Estimated Enrollment: 1015
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Shanchol stored at 2-8oC
Vaccines will be stored at 2-8oC before administration.
Drug: Shanchol
Each dose of the vaccine contains inactivated whole cell, heat killed and formalin killed bacteria measured as ELISA Units (EU) of lipopolysaccharide (LPS). It contains formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973; 600 EU); heat-killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); formalin killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48; 300 EU); and formalin killed V. cholerae O139 (4260B; 600 EU).
Experimental: Shanchol stored at 25oC
Vaccines will be stored at 25oC for 14 days before administration.
Drug: Shanchol
Each dose of the vaccine contains inactivated whole cell, heat killed and formalin killed bacteria measured as ELISA Units (EU) of lipopolysaccharide (LPS). It contains formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973; 600 EU); heat-killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); formalin killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48; 300 EU); and formalin killed V. cholerae O139 (4260B; 600 EU).
Experimental: Shanchol stored at 37oC
Vaccines will be stored at 37oC for 14 days before administration.
Drug: Shanchol
Each dose of the vaccine contains inactivated whole cell, heat killed and formalin killed bacteria measured as ELISA Units (EU) of lipopolysaccharide (LPS). It contains formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973; 600 EU); heat-killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); formalin killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48; 300 EU); and formalin killed V. cholerae O139 (4260B; 600 EU).
Experimental: Shanchol stored at 42oC
Vaccines will be stored at 42oC for 14 days before administration.
Drug: Shanchol
Each dose of the vaccine contains inactivated whole cell, heat killed and formalin killed bacteria measured as ELISA Units (EU) of lipopolysaccharide (LPS). It contains formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973; 600 EU); heat-killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); formalin killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48; 300 EU); and formalin killed V. cholerae O139 (4260B; 600 EU).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Apparently healthy individuals
  2. Age: 18-45 years
  3. Sex: Both male and female
  4. Consent: Written informed consent form for participation in the study

Exclusion Criteria:

  1. History of chronic illness, such as TB, hypertension, chronic asthma, diabetes
  2. Gastrointestinal disorder such as abdominal pain or cramps, loss of appetite, nausea, vomiting or diarrhoea in the past 7 days
  3. Intake of any anti-diarrheal medicine in the past one week or antimicrobial therapy in the past two weeks.
  4. Any febrile illness in the past 7 days.
  5. Receiving killed oral cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
  6. Immunocompromising condition or receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
  7. Females of reproductive age who are pregnant at the time of vaccination and follow up (determined by verbal screening e.g last menstrual period (LMP)).
  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: NCT01762930

Contacts
Contact: Firdausi Qadri, PhD 88-02-9840525-32 ext 2431 fqadri@icddrb.org
Contact: Amit Saha, M.Med 88-02-9840525-32 ext 3460 amit@icddrb.org

Locations
Bangladesh
International Centre for Diarrhoeal disease Research,Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Contact: Firdausi Qadri, PhD    88029840525 ext 2431    fqadri@icddrb.org   
Contact: Amit Saha, M.Med    88029840525 ext 3460    amit@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Amit Saha, M.Med International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

Publications:
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01762930     History of Changes
Other Study ID Numbers: PR-12030
Study First Received: October 16, 2012
Last Updated: April 2, 2014
Health Authority: Bangladesh: Ethical Review Committee

ClinicalTrials.gov processed this record on September 18, 2014