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

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 4

Conditions: Typhoid and/or Cholera Vaccination

Treatments: Drug: Vaxchora; Drug: Vivotif Typhoid Oral Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03705585

HP-00081568

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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

  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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Vaccination, Endoscopy

Experimental group

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.

Treatment:

Drug: Vaxchora

Drug: Vivotif Typhoid Oral Vaccine

Endoscopy, Vaccination, Endoscopy

Experimental group

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.

Treatment:

Drug: Vaxchora

Drug: Vivotif Typhoid Oral Vaccine

Endoscopy Without Vaccination

No Intervention group

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).