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

Phase 4

Recruiting

• Conditions: Typhoid and/or Cholera Vaccination
• Interventions: Drug: Vivotif Typhoid Oral Vaccine; Drug: Vaxchora

• Registration Number: NCT03705585
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-11-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

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

  8. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopy, Vaccination, Endoscopy	Vaxchora	Individuals 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.
Vaccination, Endoscopy	Vaxchora	Individuals 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.
Vaccination, Endoscopy	Vivotif Typhoid Oral Vaccine	Individuals 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, Endoscopy	Vivotif Typhoid Oral Vaccine	Individuals 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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health; 🇺🇸 Baltimore, Maryland, United States