CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

Phase

Condition

Intra-abdominal Infections

Treatment

Vivotif Typhoid Oral Vaccine

Clinical Study ID

NCT03970304

HP-00056321

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups:

Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination.

The Vivotif typhoid vaccine used in this study is 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 vaccine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 years and older
Undergoing colonoscopy for screening or surveillance for colorectal cancer at theUniversity of Maryland
Provide written informed consent prior to initiation of any study procedures
Healthy, as defined by considered fit to undergo outpatient elective colonoscopy bythe referring health care provider

Exclusion

Exclusion Criteria:

Pregnancy or nursing mother
Known coagulopathy or bleeding disorder preventing mucosal biopsy
History of Crohn's disease or ulcerative colitis
Surgical removal of the ileocecal valve or any part of the small or large intestine
Allergic reaction to oral typhoid vaccine in the past
Immunosuppression from illness or treatment, including
immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) orAcquired Immunodeficiency Syndrome (AIDS)
leukemia, lymphoma, or cancers
immune suppressive medications or treatments, such as corticosteroids orradiation
Receipt of any other vaccine two weeks prior to receipt of Ty21a
Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination

Study Design