Clinical trial NCT03705585: CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Official title: CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Typhoid and/or Cholera Vaccination
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Volunteers who choose to take part in this study will receive the licensed FDA approved Oral Typhoid Vaccine (Vivotif) and/or the licensed FDA approved Oral Cholera Vaccine (Vaxchora). Volunteers also have the possibility of being a control participant who will not be vaccinated.
Primary purpose: BASIC_SCIENCE

Brief 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 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

Primary outcomes:
measure: Percentage of Responders
timeFrame: approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Center for Vaccine Development and Global Health
state: Maryland
Study officials:
References: