CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

NCT ID: NCT03970304

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-24
• Study Completion Date: 2027-08-01

Brief Summary

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups:

Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination.

The Vivotif typhoid vaccine used in this study is 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 vaccine.

Conditions

Typhoid Vaccination

Study Design

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

Study Groups

Vaccination, Colonoscopy

Individuals receive immunization with Vivotif typhoid vaccine prior to routine colonoscopy examination. During colonoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings will 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).

Colonoscopy, Vacciniation, Colonoscopy

Individuals receive immunization with Vivotif typhoid vaccine after initial colonoscopy exam and specimen collection and prior to a routine follow up colonoscopy 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).

Colonoscopy Without Vaccination

Individuals do not receive immunization but consent to collection of specimens during colonoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum).

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

Other Intervention Names

Ty21a Typhoid Oral Vaccine

Eligibility Criteria

Inclusion Criteria

• Age 18 years and older
• Undergoing colonoscopy for screening or surveillance for colorectal cancer at the University of Maryland
• Provide written informed consent prior to initiation of any study procedures
• Healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider

Exclusion Criteria

• Pregnancy or nursing mother
• Known coagulopathy or bleeding disorder preventing mucosal biopsy
• History of Crohn's disease or ulcerative colitis
• Surgical removal of the ileocecal valve or any part of the small or large intestine
• Allergic reaction to oral typhoid vaccine in the past
• Immunosuppression from illness or treatment, including

• immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
• leukemia, lymphoma, or cancers
• immune suppressive medications or treatments, such as corticosteroids or radiation
• Receipt of any other vaccine two weeks prior to receipt of Ty21a
• 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

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

Baltimore, Maryland, United States

Countries

United States

References

Booth JS, Goldberg E, Patil SA, Barnes RS, Greenwald BD, Sztein MB. Age-dependency of terminal ileum tissue resident memory T cell responsiveness profiles to S. Typhi following oral Ty21a immunization in humans. Immun Ageing. 2021 Apr 19;18(1):19. doi: 10.1186/s12979-021-00227-y.

Reference Type: DERIVED

PMID: 33874975 (View on PubMed)

Booth JS, Goldberg E, Barnes RS, Greenwald BD, Sztein MB. Oral typhoid vaccine Ty21a elicits antigen-specific resident memory CD4+ T cells in the human terminal ileum lamina propria and epithelial compartments. J Transl Med. 2020 Feb 25;18(1):102. doi: 10.1186/s12967-020-02263-6.

Reference Type: DERIVED

PMID: 32098623 (View on PubMed)

Other Identifiers

HP-00056321

Identifier Type: -

Identifier Source: org_study_id