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

NCT ID: NCT03705585

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2029-05-31

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.

Conditions

Typhoid and/or Cholera Vaccination

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vivotif Typhoid Oral Vaccine

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Vivotif Typhoid Oral Vaccine

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ty21a Typhoid Oral Vaccine; CVD 103-HgR

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Bruce Greenwald

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosary Zara Necesario, RN

Role: CONTACT

rnecesario@som.umaryland.edu

410-706-6156

Facility Contacts

Susan Holian, RN

Role: primary

susan.holian@som.umaryland.edu

Other Identifiers

HP-00081568

Identifier Type: -

Identifier Source: org_study_id