CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera
Who is this study for? Healthy adult volunteers
What treatments are being studied? Vivotif Typhoid Oral Vaccine+Vaxchora
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Maryland
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
RECRUITING
Baltimore
Contact Information
Primary
Rosary Zara Necesario, RN
rnecesario@som.umaryland.edu
410-706-6156
Time Frame
Start Date:2018-11-05
Estimated Completion Date:2029-05-31
Participants
Target number of participants:240
Treatments
Experimental: Vaccination, Endoscopy
Individuals receive immunization with Vivotif typhoid vaccine and/or Vaxchora cholera vaccine prior to routine endoscopic examination. During endoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings might also be obtained.
Experimental: Endoscopy, Vaccination, Endoscopy
Individuals receive immunization with Vivotif typhoid vaccine and/or Vaxchora cholera vaccine after initial endoscopic exam and specimen collection and prior to a routine follow up endoscopic examination during which additional specimens will be collected.
No_intervention: Endoscopy Without Vaccination
Individuals do not receive immunization but consent to collection of specimens during endoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum if colonoscopy performed, duodenum if EGD performed).