Actively Recruiting
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Led by University of Maryland, Baltimore · Updated on 2025-06-19
240
Participants Needed
1
Research Sites
551 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Scheduled for an EGD or colonoscopy for screening, surveillance, or medically-indicated evaluation at the University of Maryland Medical Center
- Able to provide written informed consent before any study procedures
- Considered healthy and fit for outpatient elective EGD or colonoscopy by healthcare provider
You will not qualify if you...
- Pregnancy or nursing mother
- Known bleeding disorder preventing mucosal biopsy
- History of Crohn's disease or ulcerative colitis
- For colonoscopy patients: prior surgical removal of the ileocecal valve or any part of the small or large intestine (non-complicated appendectomy allowed)
- Previous allergic reaction to oral typhoid or cholera vaccine
- Immunosuppression due to illness or treatment, including HIV/AIDS, leukemia, lymphoma, or active cancers (inactive localized non-melanoma skin cancers allowed)
- Receipt of any other vaccine within two weeks before Ty21a or CVD 103-HgR vaccine
- Positive urine pregnancy test before colonoscopy or vaccination
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
R
Rosary Zara Necesario, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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