Menu
Recruiting NCT03705585

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

Phase IV Interventional Typhoid and/or Cholera Vaccination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vivotif Typhoid Oral Vaccine, Vaxchora.
Who it may be relevant to
Registry conditions: Typhoid and/or Cholera Vaccination. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera

Overview

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.

Interventions

  • Drug Vivotif Typhoid Oral Vaccine
    The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
  • Drug Vaxchora
    One dose. Approximately 100 mL of cool or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.

Primary outcome measures

  • Percentage of Responders [Time frame: approximately 5 years]

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
  • immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health — Baltimore

Identifiers

NCT: NCT03705585 · HP-00081568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗