Understanding immune responses to typhoid and cholera vaccines
Official title: CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera
Run by University of Maryland, Baltimore · NCT03705585 · Data updated 2026-11-12
This study is testing how the typhoid and cholera vaccines affect the immune system and gut bacteria in people who are having endoscopies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | November 5, 2018 |
| Main results expected | May 31, 2029 |
| Study ends | May 31, 2029 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT03705585 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18 and older who are scheduled for an endoscopy at the University of Maryland Medical Center.
✕Probably not a fit
Patients who are pregnant, have a history of inflammatory bowel disease, or have had allergic reactions to the vaccines may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, non-randomized study aims to investigate how the typhoid and cholera vaccines influence the immune system and intestinal bacteria. Participants scheduled for endoscopies will be divided into three groups: one receiving vaccinations before the procedure, another receiving vaccinations after, and a control group undergoing endoscopy without vaccination. The study will collect tissue, blood, saliva, and stool samples to analyze the immune response to the vaccines. Both vaccines used are FDA-approved for travelers to developing countries.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of vaccine-induced immune responses, potentially leading to improved vaccination strategies.
How similar studies have gone: While studies on vaccine responses are common, this specific approach to studying typhoid and cholera vaccines in conjunction with endoscopic procedures is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States Recruiting
Study contacts
- Study coordinator: Rosary Zara Necesario, RN
- Email: rnecesario@som.umaryland.edu
- Phone: 410-706-6156
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.