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

Primary Purpose

Typhoid Vaccination

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vivotif Typhoid Oral Vaccine
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Typhoid Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Vaccination, Colonoscopy

Colonoscopy, Vacciniation, Colonoscopy

Colonoscopy Without Vaccination

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

Percentage of Responders
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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2019
Last Updated
November 9, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03970304
Brief Title
CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 24, 2013 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid Vaccination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccination, Colonoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Colonoscopy, Vacciniation, Colonoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Colonoscopy Without Vaccination
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Vivotif Typhoid Oral Vaccine
Other Intervention Name(s)
Ty21a Typhoid Oral Vaccine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of Responders
Description
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.
Time Frame
approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33874975
Citation
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.
Results Reference
derived
PubMed Identifier
32098623
Citation
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.
Results Reference
derived

Learn more about this trial

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

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