Clinical trial NCT03970304: CVD 37000: Immunity and Microbiome Studies At Intestinal and Systemic Sites in Ty21a Vaccinated Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Typhoid Vaccination
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Percentage of Responders
timeFrame: approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health
state: Maryland
Study officials:
References:
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.
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.