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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:
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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 weeks
Treatment ~ Varies
Follow Up ~day 1, 3, 16, 18, 22, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 3, 16, 18, 22, and 24 for reporting.

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 more

Trial 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.

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

Vivotif Typhoid Oral Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04083950 — Phase < 1
Typhoid Research Study Groups: Single group
Typhoid Clinical Trial 2023: Vivotif Typhoid Oral Vaccine Highlights & Side Effects. Trial Name: NCT04083950 — Phase < 1
Vivotif Typhoid Oral Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083950 — Phase < 1
~2 spots leftby Oct 2025