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

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: NCT03970304
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Bruce Greenwald, University of Maryland, Baltimore

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 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

Resource links provided by the National Library of Medicine


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).



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970304


Locations
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United States, Maryland
Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bruce Greenwald, Professor of Medicine, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03970304    
Other Study ID Numbers: HP-00056321
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs