drugset / Trial / NCT03705585

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

NCT03705585

Phase 4 Recruiting 240 enrolled University of Maryland, Baltimore
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2018-11-05
Primary completion
2029-05-31
Completion
2029-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject PXVX0200 Vaccine
Subject Vivotif Vaccine 1 unknown

Indications

No indication recorded.