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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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
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
692 Previous Clinical Trials
376,777 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder that prevents safe biopsy procedures.I am scheduled for a colonoscopy at the University of Maryland for cancer screening.You had an allergic reaction to a typhoid vaccine that you took by mouth in the past.I have a history of Crohn's disease or ulcerative colitis.I am 18 years old or older.I have had surgery to remove part of my intestine.You have a weakened immune system due to a medical condition like HIV/AIDS, leukemia, lymphoma, or cancer. You are taking medications or treatments that suppress your immune system, like corticosteroids or radiation. You have received another vaccine within two weeks before the study or have tested positive for pregnancy before undergoing colonoscopy or vaccination.
Research Study Groups:
This trial has the following groups:- Group 1: Vaccination, Colonoscopy
- Group 2: Colonoscopy, Vacciniation, Colonoscopy
- Group 3: Colonoscopy Without Vaccination
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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