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

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Oct 10, 2018

Keywords

ClinConnect Summary

This clinical trial, called CVD 38000, is studying how well vaccines for typhoid fever and cholera work in the body, especially focusing on the immune system and gut bacteria. The trial involves patients who are already scheduled for certain procedures called endoscopies (which include colonoscopy and esophagogastroduodenoscopy). Participants will be placed into three groups: one group will receive the typhoid and/or cholera vaccines before their endoscopy, another group will receive the vaccines afterward, and the last group will have the endoscopy without vaccination. All vaccines being used are approved by the FDA for travelers to areas where these diseases are common.

To participate in this study, individuals must be at least 18 years old, in good health, and already scheduled for an endoscopy at the University of Maryland Medical Center. They also need to be able to provide written consent. Participants will donate samples like blood, saliva, and stool to help researchers understand how the vaccines affect their bodies. It's important to note that certain conditions, such as pregnancy or specific health issues, may prevent someone from joining the study. Overall, this trial aims to help improve our understanding of these vaccines and their effects on the immune system.

Gender

ALL

Eligibility 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