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

NCT03705585 — Phase 4, Recruiting, 240 participants, University of Maryland, Baltimore
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CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera

RegistryNCT03705585
StatusRecruiting
PhasePhase 4
Study typeInterventional; non randomized, parallel, masking: none, basic science
Enrollment240 (Estimated)
SponsorUniversity of Maryland, Baltimore (Other)
ConditionsTyphoid and/or Cholera Vaccination
InterventionsVivotif Typhoid Oral Vaccine, Vaxchora (Drug)
Datesstart 2018-11-05, primary completion 2029-05-31 (estimated), completion 2029-05-31 (estimated), first posted 2018-10-15, last updated 2026-09-04
Locations1 site in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Vaccination, EndoscopyExperimentalDrug: Vivotif Typhoid Oral Vaccine; Drug: VaxchoraIndividuals receive immunization with Vivotif typhoid vaccine and/or Vaxchora cholera vaccine prior to routine endoscopic examination. During endoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings might also be obtained.
Endoscopy, Vaccination, EndoscopyExperimentalDrug: Vivotif Typhoid Oral Vaccine; Drug: VaxchoraIndividuals receive immunization with Vivotif typhoid vaccine and/or Vaxchora cholera vaccine after initial endoscopic exam and specimen collection and prior to a routine follow up endoscopic examination during which additional specimens will be collected.
Endoscopy Without VaccinationNo interventionIndividuals do not receive immunization but consent to collection of specimens during endoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum if colonoscopy performed, duodenum if EGD performed).
  • Vivotif Typhoid Oral Vaccine (Drug), also known as Ty21a 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).
  • Vaxchora (Drug), also known as CVD 103-HgR: 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.

+Outcome measures

Primary outcomes

  • Percentage of Responders [approximately 5 years]: 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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimore, MarylandUnited StatesRecruiting

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