← Back to Search

Vaccine

Typhoid Vaccine for Typhoid

Phase 4

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Be older than 18 years old

Must not have

Known coagulopathy or bleeding disorder preventing mucosal biopsy

History of Crohn's disease or ulcerative colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will help researchers understand how the typhoid vaccine affects the immune system and bacteria in the intestine. Volunteers will be divided into 3 groups: those who receive the vaccine before a colonoscopy, those who receive the vaccine after a colonoscopy, and those who only have a colonoscopy. Blood, tissue, saliva, and stool samples will be collected from all volunteers to study the body's response to the vaccine.

Who is the study for?

This trial is for adults over 18 who are healthy and undergoing a colonoscopy for colorectal cancer screening at the University of Maryland. They must be able to give consent and not have a history of certain bowel diseases, bleeding disorders, or immune suppression from illness or treatment. Pregnant or nursing women and those with past allergic reactions to the typhoid vaccine cannot participate.

What is being tested?

The study investigates how the Vivotif typhoid oral vaccine affects the body's immune system and gut bacteria in people getting colonoscopies. Participants will be split into three groups: one receiving vaccination before colonoscopy, another after colonoscopy with follow-up, and a third having just the colonoscopy.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with vaccines like Vivotif may include temporary digestive issues, fever, headache, fatigue or mild skin rash. Serious side effects are rare but can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a bleeding disorder that prevents safe biopsy procedures.

Select...

I have a history of Crohn's disease or ulcerative colitis.

Select...

I have had surgery to remove part of my intestine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Responders

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Vaccination, ColonoscopyExperimental Treatment1 Intervention

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 II: Colonoscopy, Vacciniation, ColonoscopyExperimental Treatment1 Intervention

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 III: Colonoscopy Without VaccinationActive Control1 Intervention

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).

0 / 4Eligibility criteria met