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出境医 / 临床实验 / CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

Study Description
Brief Summary:

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups:

Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination.

The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.


Condition or disease Intervention/treatment Phase
Typhoid Vaccination Drug: Vivotif Typhoid Oral Vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Volunteers who choose to take part in this study will receive the licensed FDA approved Oral Typhoid Vaccine (Vivotif). Volunteers also have the possibility of being a control participant who will not be vaccinated.
Masking: None (Open Label)
Primary Purpose: Basic Science
Actual Study Start Date : October 24, 2013
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Vaccination, Colonoscopy
Individuals receive immunization with Vivotif typhoid vaccine prior to routine colonoscopy examination. During colonoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings will also be obtained.
 Drug: Vivotif Typhoid Oral Vaccine
The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
Other Name: Ty21a Typhoid Oral Vaccine
Experimental: Colonoscopy, Vacciniation, Colonoscopy
Individuals receive immunization with Vivotif typhoid vaccine after initial colonoscopy exam and specimen collection and prior to a routine follow up colonoscopy examination during which additional specimens will be collected.
 Drug: Vivotif Typhoid Oral Vaccine
The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
Other Name: Ty21a Typhoid Oral Vaccine
No Intervention: Colonoscopy Without Vaccination
Individuals do not receive immunization but consent to collection of specimens during colonoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum).
Outcome Measures
Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: approximately 5 years ]
    Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of >0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Undergoing colonoscopy for screening or surveillance for colorectal cancer at the University of Maryland
  • Provide written informed consent prior to initiation of any study procedures
  • Healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider

Exclusion Criteria:

  • Pregnancy or nursing mother
  • Known coagulopathy or bleeding disorder preventing mucosal biopsy
  • History of Crohn's disease or ulcerative colitis
  • Surgical removal of the ileocecal valve or any part of the small or large intestine
  • Allergic reaction to oral typhoid vaccine in the past

  • Immunosuppression from illness or treatment, including

    • immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
    • leukemia, lymphoma, or cancers
    • immune suppressive medications or treatments, such as corticosteroids or radiation
  • Receipt of any other vaccine two weeks prior to receipt of Ty21a
  • Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
Contacts and Locations

Contacts
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Contact: Robin Barnes, CRNP 410-706-6156 rbarnes@som.umaryland.edu

Locations
Layout table for location information
United States, Maryland
Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robin Barnes, CRNP    410-706-6156    rbarnes@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE October 24, 2013
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019) 		Percentage of Responders [ Time Frame: approximately 5 years ]
Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of >0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.
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 CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults
Official Title  ICMJE Not Provided
Brief Summary

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups:

Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination.

The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Volunteers who choose to take part in this study will receive the licensed FDA approved Oral Typhoid Vaccine (Vivotif). Volunteers also have the possibility of being a control participant who will not be vaccinated.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Typhoid Vaccination
Intervention  ICMJE Drug: Vivotif Typhoid Oral Vaccine
The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
Other Name: Ty21a Typhoid Oral Vaccine
Study Arms  ICMJE
  • Experimental: Vaccination, Colonoscopy
    Individuals receive immunization with Vivotif typhoid vaccine prior to routine colonoscopy examination. During colonoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings will also be obtained.
    Intervention: Drug: Vivotif Typhoid Oral Vaccine
  • Experimental: Colonoscopy, Vacciniation, Colonoscopy
    Individuals receive immunization with Vivotif typhoid vaccine after initial colonoscopy exam and specimen collection and prior to a routine follow up colonoscopy examination during which additional specimens will be collected.
    Intervention: Drug: Vivotif Typhoid Oral Vaccine
  • No Intervention: Colonoscopy Without Vaccination
    Individuals do not receive immunization but consent to collection of specimens during colonoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum).
Publications *
  • Booth JS, Goldberg E, Patil SA, Barnes RS, Greenwald BD, Sztein MB. Age-dependency of terminal ileum tissue resident memory T cell responsiveness profiles to S. Typhi following oral Ty21a immunization in humans. Immun Ageing. 2021 Apr 19;18(1):19. doi: 10.1186/s12979-021-00227-y.
  • Booth JS, Goldberg E, Barnes RS, Greenwald BD, Sztein MB. Oral typhoid vaccine Ty21a elicits antigen-specific resident memory CD4(+) T cells in the human terminal ileum lamina propria and epithelial compartments. J Transl Med. 2020 Feb 25;18(1):102. doi: 10.1186/s12967-020-02263-6.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years and older
  • Undergoing colonoscopy for screening or surveillance for colorectal cancer at the University of Maryland
  • Provide written informed consent prior to initiation of any study procedures
  • Healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider

Exclusion Criteria:

  • Pregnancy or nursing mother
  • Known coagulopathy or bleeding disorder preventing mucosal biopsy
  • History of Crohn's disease or ulcerative colitis
  • Surgical removal of the ileocecal valve or any part of the small or large intestine
  • Allergic reaction to oral typhoid vaccine in the past

  • Immunosuppression from illness or treatment, including

    • immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
    • leukemia, lymphoma, or cancers
    • immune suppressive medications or treatments, such as corticosteroids or radiation
  • Receipt of any other vaccine two weeks prior to receipt of Ty21a
  • Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robin Barnes, CRNP 410-706-6156 rbarnes@som.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970304
Other Study ID Numbers  ICMJE HP-00056321
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bruce Greenwald, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date September 2020

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

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