Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705585
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Bruce Greenwald, 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.


Condition or disease Intervention/treatment Phase
Typhoid and/or Cholera Vaccination Drug: Vivotif Typhoid Oral Vaccine Drug: Vaxchora Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and/or Cholera
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera

Arm Intervention/treatment
Experimental: Vaccination, Endoscopy
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.
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).
Other Name: Ty21a Typhoid Oral Vaccine

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.
Other Name: CVD 103-HgR

Experimental: Endoscopy, Vaccination, Endoscopy
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.
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).
Other Name: Ty21a Typhoid Oral Vaccine

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.
Other Name: CVD 103-HgR

No Intervention: Endoscopy Without Vaccination
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).



Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705585


Contacts
Layout table for location contacts
Contact: Robin Barnes, CRNP 410-706-6156 rbarnes@som.umaryland.edu

Locations
Layout table for location information
United States, Maryland
University of Maryland, Baltimore, Center for Vaccine Development and Global Health Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robin Barnes, CRNP         
Sponsors and Collaborators
University of Maryland, Baltimore
Layout table for additonal information
Responsible Party: Bruce Greenwald, Professor of Medicine, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03705585    
Other Study ID Numbers: HP-00081568
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholera
Typhoid Fever
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Salmonella Infections
Enterobacteriaceae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs