Protective Immunity to Human Cholera in Bangladesh

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Brief Title

Protective Immunity to Human Cholera in Bangladesh

Official Title

Protective Immunity to Human Cholera in Bangladesh-EGD Substudy

Brief Summary

      The purpose of this study is to better understand how the body fights and protects against
      cholera. Two hundered fifty people presenting to the International Centre for Diarrhoeal
      Diseases Research, Bangladesh, admitted with acute cholera, 50 of whom (healthy, nonpregnant,
      18-45 year olds) will be enrolled in this substudy of mucosal immunity involving duodenal
      biopsy. The remainder of the study is observational, involving collection of stool, vomit,
      and blood samples only. The biopsy requires a flexible tube with a camera be inserted through
      the mouth into the stomach and intestine. During this procedure, small samples will be
      collected from the intestine. The study includes medical history, physical, blood testing,
      hospitalization and urine pregnancy testing. This study will last for 5 years and patients
      will participate for 3 years.
    

Detailed Description

      Diarrheal diseases are some of the most common causes of morbidity and mortality in the world
      today. Unfortunately, effective vaccines for most of the infectious causes of diarrhea are
      not yet available. Vibrio cholerae (V cholerae) is an important infectious cause of severe
      secretory diarrhea in humans. The purpose of this study is to assess the duration of immune
      responses in a group of 250 individuals, aged 2-60 years, presenting to the International
      Centre for Diarrheal Diseases Research, Bangladesh (ICDDR,B) hospital who are admitted with
      acute cholera. Fifty of these participants will be enrolled in a substudy of mucosal immunity
      involving duodenal biopsy. This protocol focuses exclusively on the subset of 50 study
      participants (healthy 18-45 year old non pregnant subjects) enrolled in the substudy of
      mucosal immunity involving duodenal biopsy. This study is linked to DMID protocol 06-0045.
      The remainder of the study is observational, involving collection of stool, vomit, and blood
      samples only (DMID protocol 06-0045). A duodenal biopsy will be performed on enrollment or
      the next day and at Day 30. Twenty five subjects will undergo a third duodenal biopsy after 6
      months of follow-up and 25 subjects will undergo a third duodenal biopsy after 12 months
      follow-up. The objectives of this study are as follows: to measure immune responses directed
      against Vibrio cholerae antigens and evaluate the development of anti-V cholerae memory B
      cells in study participants with cholera; to assess the duration of the immune responses
      following an episode of cholera; and to correlate the duration of antigen-specific,
      antibody-secreting cells for various cholera antigens in duodenal tissue with measurements of
      the duration of immunity based on antibody responses in serum, as well as circulating
      antigen-specific memory B cells. This is a single site study with a 5 year duration requiring
      three years of patient participation.
    


Study Type

Observational


Primary Outcome

Serum antibody responses to V cholerae Lipopolysaccharide (LPS) and Cholera Toxin, B Subunit (CTB) (and other antigens as needed) on Days 2, 7, and 30 and at Months 3, 6, 9, 12, 18, 24, 30, and 36 following enrollment.


Condition

Cholera


Study Arms / Comparison Groups

 1
Description:  18 males and non pregnant females, ages 18-45, with acute cholera.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

125

Start Date

June 2008

Completion Date

December 2012

Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

        For the esophagogastroduodenoscopy (EGD) substudy of 50 study participants

          -  Admission to the International Centre for Diarrhoeal Diseases Research, Bangladesh
             (ICDDR,B) with acute cholera

          -  Male or nonpregnant female [pregnancy will be excluded by urine human chorionic
             gonadotropin (HCG) testing]

          -  Age 18 to 45 years, inclusive

          -  Residence in Dhaka city

          -  Provision of informed consent for enrollment in study

          -  Expressed interest and availability to fulfill the study requirements

        Exclusion Criteria:

        For the esophagogastroduodenoscopy (EGD) substudy of 50 study participants

          -  Participation in any other investigational drug, device or vaccine trial at present or
             within the past 30 days

          -  Known allergy to midazolam or topical anesthetics

          -  Presence of comorbid conditions, including:

          -  heart disease

          -  pulmonary disease

          -  liver disease

          -  kidney disease

          -  bleeding disorder

          -  neurologic disorder

          -  an additional intestinal disorder

          -  pregnancy

          -  anemia (hemoglobin < 12 g/dl for males or < 11 g/dl for female)

          -  hypotension (systolic blood pressure less than or equal to 85 mm Hg or diastolic blood
             pressure less than or equal to 55 mm Hg, measured in the supine position once just
             prior to procedure)

          -  hypertension (systolic blood pressure greater than or equal to 150 mm Hg or diastolic
             blood pressure greater than or equal to 90 mm Hg, measured in the supine position once
             just prior to procedure)
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Bangladesh

Location Countries

Bangladesh

Administrative Informations


NCT ID

NCT00349999

Organization ID

05-0103

Secondary IDs

5U01AI058935-14


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

, , 


Verification Date

October 2009