RECRUITING

CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are 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 and/or cholera vaccine.

Official Title

CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera

Quick Facts

Study Start:2018-11-05

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03705585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 1. Age 18 years and older * 2. Already scheduled to undergo an EGD or colonoscopy for screening, surveillance, or a medically-indicated work-up at the University of Maryland Medical Center (main campus or Midtown) * 3. Able to provide written informed consent prior to initiation of any study procedures * 4. Healthy, as defined by considered fit to undergo outpatient elective EGD/colonoscopy by the evaluating health care provider	* 1. Pregnancy or nursing mother * 2. Known coagulopathy or bleeding disorder preventing mucosal biopsy * 3. History of Crohn's disease or ulcerative colitis * 4. For Subjects undergoing lower endoscopy (colonoscopy) only: Surgical removal of the ileocecal valve or any part of the small or large intestine (non-complicated appendectomy will be considered eligible) * 5. Allergic reaction to oral typhoid or cholera vaccine in the past * 6. Immunosuppression from illness or treatment, including 1. immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) 2. leukemia, lymphoma, or cancers (localized non-melanoma skin cancers which are deemed inactive should be considered eligible) * 7. Receipt of any other vaccine two weeks prior to receipt of Ty21a or CVD 103-HgR * 8. Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination

Inclusion Criteria

Exclusion Criteria

* 1. Age 18 years and older
* 2. Already scheduled to undergo an EGD or colonoscopy for screening, surveillance, or a medically-indicated work-up at the University of Maryland Medical Center (main campus or Midtown)
* 3. Able to provide written informed consent prior to initiation of any study procedures
* 4. Healthy, as defined by considered fit to undergo outpatient elective EGD/colonoscopy by the evaluating health care provider

* 1. Pregnancy or nursing mother
* 2. Known coagulopathy or bleeding disorder preventing mucosal biopsy
* 3. History of Crohn's disease or ulcerative colitis
* 4. For Subjects undergoing lower endoscopy (colonoscopy) only: Surgical removal of the ileocecal valve or any part of the small or large intestine (non-complicated appendectomy will be considered eligible)
* 5. Allergic reaction to oral typhoid or cholera vaccine in the past
* 6. Immunosuppression from illness or treatment, including
1. immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
2. leukemia, lymphoma, or cancers (localized non-melanoma skin cancers which are deemed inactive should be considered eligible)
* 7. Receipt of any other vaccine two weeks prior to receipt of Ty21a or CVD 103-HgR
* 8. Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination

Contacts and Locations

Study Contact

Susan Holian, RN

CONTACT

410-706-6156

susan.holian@som.umaryland.edu

Study Locations (Sites)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-05

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2018-11-05

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Typhoid and/or Cholera Vaccination