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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03705585
Other study ID # HP-00081568
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 5, 2018
Est. completion date May 31, 2025

Study information

Verified date January 2024
Source University of Maryland, Baltimore
Contact Susan Holian, RN
Phone 410-706-6156
Email susan.holian@som.umaryland.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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).
Vaxchora
One dose. Approximately 100 mL of cool or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.

Locations

Country Name City State
United States University of Maryland, Baltimore, Center for Vaccine Development and Global Health Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Responders Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-a)) 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-a over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-a)) by mass cytometry or flow cytometry. approximately 5 years