Impact of Typhoid Vaccine on Immune System and Intestinal Bacteria in Adults
This study aims to evaluate how the typhoid vaccine affects the immune system and intestinal bacteria in adults, by measuring the percentage of responders through the production of specific cytokines, Interferon-gamma or Tumor Necrosis Factor-alpha, post-immunization.
Vivotif Typhoid Oral Vaccine
Basic Science Study
Summary
Study start date: October 24, 2013
Actual date on which the first participant was enrolled.This study aims to understand how typhoid vaccines impact the immune system and intestinal bacteria. It focuses on adults who are scheduled for standard colonoscopies. The study uses Vivotif, a typhoid vaccine approved by the Food and Drug Administration (FDA) for travelers to developing countries. The research is important as it can help improve our understanding of how the body responds to typhoid vaccines, potentially leading to better vaccination strategies and care for those at risk of typhoid fever. Participants are divided into three groups. The first group receives the typhoid vaccine before the colonoscopy, the second group has a colonoscopy first, then gets the vaccine and a follow-up colonoscopy, and the third group has a colonoscopy without vaccination. Participants are asked to provide tissue, blood, saliva, and stool samples. The study measures the percentage of responders by looking at the production of certain proteins (Interferon-gamma or Tumor Necrosis Factor-alpha) in CD8+ cells after vaccination. A responder is defined as someone showing an increase of more than 0.1% of positive CD8+ cells for these proteins over baseline values.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.87 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Age 18 years and older * Undergoing colonoscopy for screening or surveillance for colorectal cancer at the University of Maryland * Provide written informed consent prior to initiation of any study procedures * Healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider 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) or Acquired Immunodeficiency Syndrome (AIDS) * leukemia, lymphoma, or cancers * immune suppressive medications or treatments, such as corticosteroids or radiation * Receipt of any other vaccine two weeks prior to receipt of Ty21a * Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, United StatesOpen Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health in Google Maps