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Vaccine
Vivotif Typhoid Oral Vaccine for Typhoid
Phase < 1
Waitlist Available
Led By Danielle Lemay, PhD
Research Sponsored by USDA, Western Human Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 3, 16, 18, 22, and 24
Awards & highlights
Study Summary
This trial looks at how well a typhoid vaccine works in preventing disease and measuring the body's response to the vaccine.
Who is the study for?
This trial is for healthy adults with a BMI of 18.5-29.9 who haven't used antibiotics or been hospitalized recently, and don't have immune system diseases like HIV/AIDS, cancer, high blood pressure, or chronic illnesses. Pregnant women and those unwilling to use birth control or take an HIV test are excluded.Check my eligibility
What is being tested?
The study tests the impact of an oral typhoid vaccine on gut barrier function and immune response. Participants will undergo intestinal and whole-body assessments before and after receiving the vaccine compared to aspirin as a positive control.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as temporary digestive disturbances, mild fever, or local irritation at injection sites. Aspirin can cause stomach upset, bleeding risks, allergic reactions in sensitive individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 3, 16, 18, 22, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 3, 16, 18, 22, and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in intestinal permeability
Secondary outcome measures
Antibody response to typhoid vaccination
Change in D-lactate
Citrulline
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single groupExperimental Treatment2 Interventions
All participants will receive the vaccine and aspirin.
Find a Location
Who is running the clinical trial?
USDA, Western Human Nutrition Research CenterLead Sponsor
62 Previous Clinical Trials
21,097 Total Patients Enrolled
Danielle Lemay, PhDPrincipal InvestigatorUSDA, ARS, Western Human Nutrition Research Center
2 Previous Clinical Trials
455 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take blood thinners every day.I am currently undergoing cancer treatment with radiation or medication.I am currently taking or have recently taken anti-malaria medication.I have not had a fever or flu-like symptoms in the last 2 weeks.I am taking medication for high blood pressure.I have a history of bleeding disorders, including GI tract bleeding.You are not willing to stop consuming artificial sweeteners found in certain foods and drinks, like sports drinks, "diet" drinks, and foods with ingredients like sucralose.I have not had severe diarrhea or constant vomiting in the last 2 weeks.I have had surgery on my digestive system.You are at a higher risk of experiencing problems from a live bacterial vaccine.I haven't received any vaccines in the two weeks before getting the Ty21a vaccine.I have had typhoid fever in the past.I have been using immune system affecting drugs for 2 weeks or more.I have HIV/AIDS or another immune system condition.I am not okay with having my blood drawn seven times in 29 days.You are allergic to certain ingredients in the vaccine, like Thimerosal and enteric-coated capsules.I have been diagnosed with cancer.I do not have a vein in my arm suitable for drawing blood.I have a chronic illness such as diabetes, heart disease, or liver disease.I have a history of stomach or bowel problems like Crohn's or ulcers.I have asthma and take medication for it every day.I have not had surgery in the last 3 months.I regularly take anti-inflammatory medications like aspirin or NSAIDs.You are allergic to the oral typhoid vaccine.You are allergic to aspirin.You have a history of a weak immune system or an autoimmune disease.I have received the typhoid vaccine within the last 5 years.I have not taken sulfonamides or antibiotics in the last 30 days.Your body mass index (BMI) is within the healthy range, which means you are not too underweight or overweight.
Research Study Groups:
This trial has the following groups:- Group 1: Single group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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