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

Primary Purpose

Typhoid and/or Cholera Vaccination

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vivotif Typhoid Oral Vaccine
Vaxchora
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Typhoid and/or Cholera Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Maryland, Baltimore, Center for Vaccine Development and Global HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Vaccination, Endoscopy

Endoscopy, Vaccination, Endoscopy

Endoscopy Without Vaccination

Arm Description

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.

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.

Individuals 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2018
Last Updated
May 12, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03705585
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid and/or Cholera Vaccination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccination, Endoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Endoscopy, Vaccination, Endoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Endoscopy Without Vaccination
Arm Type
No Intervention
Arm Description
Individuals 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).
Intervention Type
Drug
Intervention Name(s)
Vivotif Typhoid Oral Vaccine
Other Intervention Name(s)
Ty21a Typhoid Oral Vaccine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Vaxchora
Other Intervention Name(s)
CVD 103-HgR
Intervention Description
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 Measure Information:
Title
Percentage of Responders
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Barnes, CRNP
Phone
410-706-6156
Email
rbarnes@som.umaryland.edu
Facility Information:
Facility Name
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Barnes, CRNP

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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