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

ConditionTyphoid and/or Cholera Vaccination

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Maryland, Baltimore

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Vivotif Typhoid Oral Vaccine
Drug
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).
Vaxchora
Drug
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.

Treatment groups

240 Participants

are divided into 3 treatment groups

Group A: Vaccination, EndoscopyExperimental treatment 2 interventions

Group B: Endoscopy, Vaccination, EndoscopyExperimental treatment 2 interventions

Group C: Endoscopy Without VaccinationNo intervention 0 interventions

Trial outcomes

Primary outcomes

Percentage of Responders

Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of \>0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.

Time frame

approximately 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

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