What side effects are associated with this type of intervention?

The oral typhoid vaccine, which stimulates the immune response to typhoid bacteria, is generally well-tolerated but can cause mild side effects such as fever, headache, nausea, abdominal pain, and diarrhea. Severe reactions are rare. Common antibiotic treatments for typhoid, such as ciprofloxacin and azithromycin, may cause side effects including gastrointestinal disturbances (nausea, vomiting, diarrhea), allergic reactions, and, in rare cases, more serious effects like tendonitis or liver toxicity.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of typhoid fever, including the oral Ty21a vaccine and the injectable Vi capsular polysaccharide vaccine. These vaccines work by stimulating the immune system to recognize and fight off the typhoid bacteria, similar to the oral typhoid vaccine being studied for its effects on the intestinal barrier and immune response. The oral Ty21a vaccine is particularly relevant as it is administered orally and aims to induce immunity in the gut, where the typhoid bacteria typically invade.

What other types of research exist?

Promising novel alternatives to the oral typhoid vaccine for 2024 include conjugate vaccines, which have shown improved immunogenicity and longer-lasting protection. Additionally, advancements in DNA vaccines and vector-based vaccines, such as those using adenovirus vectors, are under investigation and may offer effective alternatives. These new approaches aim to enhance immune response and provide broader protection against typhoid bacteria.

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Vaccine

Typhoid Vaccine for Gut Health

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single groupExperimental Treatment2 Interventions

All participants will receive the vaccine and aspirin.

0 / 14Eligibility criteria met

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.