Typhoid Vaccine for Gut Health

Recruiting in Palo Alto (17 mi)

Overseen byDanielle Lemay, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: USDA, Western Human Nutrition Research Center

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) is within the healthy range, which means you are not too underweight or overweight.

Exclusion 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.

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Treatment Details

Interventions

Aspirin (Other)
Vivotif Typhoid Oral Vaccine (Vaccine)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single groupExperimental Treatment2 Interventions

All participants will receive the vaccine and aspirin.

Vivotif Typhoid Oral Vaccine is already approved in United States for the following indications:

🇺🇸 Approved in United States as Vivotif for:

Immunization against disease caused by Salmonella typhi for travelers to areas where there is a recognized risk of exposure to S. typhi, persons with intimate exposure to an S. typhi carrier, and microbiology laboratorians who work frequently with S. typhi