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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Responders

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).

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,559 Total Patients Enrolled

Media Library

Vivotif Typhoid Oral Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03970304 — Phase 4
Typhoid Vaccine Research Study Groups: Vaccination, Colonoscopy, Colonoscopy, Vacciniation, Colonoscopy, Colonoscopy Without Vaccination
Typhoid Vaccine Clinical Trial 2023: Vivotif Typhoid Oral Vaccine Highlights & Side Effects. Trial Name: NCT03970304 — Phase 4
Vivotif Typhoid Oral Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03970304 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for participants in this clinical investigation?

"Currently, this medical study is not accepting participants. Initially posted on October 24th 2013 and last updated November 9th 2022, it has since been closed off in lieu of other studies concerning typhoid fever which have 10 active clinical trials alongside 4 seeking patients for Vivotif Typhoid Oral Vaccine."

Answered by AI

What is the total patient count for this clinical investigation?

"This research has ceased recruiting participants. It was first published on October 24th, 2013 and its last update occurred on November 9th 2022. 10 trials focusing on typhoid fever are still accepting patients as well as 4 studies of Vivotif Typhoid Oral Vaccine."

Answered by AI

Are there any prior studies that have looked into the efficacy of Vivotif Typhoid Oral Vaccine?

"Currently, 4 clinical trials are active in the research of Vivotif Typhoid Oral Vaccine. None of these experiments have reached Phase 3 yet. Of those sites conducting studies on this treatment, most are situated around Baltimore Maryland while a few others dot other locations across America."

Answered by AI

Does the Vivotif Typhoid Oral Vaccine present any adverse risks for human subjects?

"Vivotif Typhoid Oral Vaccine has been approved, so our team at Power rated its safety a 3 on the 1-3 scale."

Answered by AI
~1 spots leftby Jun 2024