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Vaccine
Typhoid Vaccine for Gut Health
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
Must not have
Daily use of blood thinners
Is taking cancer treatment with radiation or drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 3, 16, 18, 22, and 24
Awards & highlights
Summary
This trial uses an oral typhoid vaccine to study its effects on the gut and immune system in travelers to areas where typhoid is common. The vaccine helps the body recognize and fight typhoid bacteria. The oral typhoid vaccine, Ty21a, has been licensed in the United States and has been in use for more than two decades.
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take blood thinners every day.
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I am currently undergoing cancer treatment with radiation or medication.
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I am currently taking or have recently taken anti-malaria medication.
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I have a history of bleeding disorders, including GI tract bleeding.
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I have not had severe diarrhea or constant vomiting in the last 2 weeks.
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I have had surgery on my digestive system.
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I have had typhoid fever in the past.
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I have HIV/AIDS or another immune system condition.
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I am not okay with having my blood drawn seven times in 29 days.
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I have been diagnosed with cancer.
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I do not have a vein in my arm suitable for drawing blood.
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I have a history of stomach or bowel problems like Crohn's or ulcers.
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I have asthma and take medication for it every day.
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I regularly take anti-inflammatory medications like aspirin or NSAIDs.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in intestinal permeability
Secondary study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The oral typhoid vaccine stimulates the immune system to recognize and respond to the typhoid bacteria by introducing a weakened or inactivated form of the bacteria. This prompts the immune system to produce antibodies, providing immunity against future infections.
This mechanism is crucial for Typhoid patients as it helps prevent the onset of the disease, reducing the incidence and severity of infections, and ultimately improving public health outcomes.
The Design and Analysis of Seroefficacy Studies for Typhoid Conjugate Vaccines.
The Design and Analysis of Seroefficacy Studies for Typhoid Conjugate Vaccines.
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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.
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