Typhoid Vaccine for Gut Health

Overseen By Yuriko Adkins, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: USDA, Western Human Nutrition Research Center

Must not be taking: Blood thinners, NSAIDs, Antibiotics, Immunosuppressants

Disqualifiers: HIV/AIDS, Cancer, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 26

Duration: 4 weeks

10 Participants Needed

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.

Research Team

Danielle Lemay, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Baseline gut permeability and immune response measurements are taken before vaccination

1 week

1 visit (in-person)

Treatment

Participants receive the Ty21a oral typhoid vaccine and aspirin, with gut permeability and immune response measured after each dose

4 weeks

Multiple visits on Day 1, 3, 16, 18, and 22

Follow-up

Participants are monitored for immune response and changes in gut permeability after the final vaccine dose

1 week

Visits on Day 24 and 29

Treatment Details

Interventions

• Aspirin
• Vivotif Typhoid Oral Vaccine

Trial Overview 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.

Participant Groups

Group I: Single group Experimental Treatment 2 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

Who Is Running the Clinical Trial?

USDA, Western Human Nutrition Research Center

Lead Sponsor

Trials

64

Recruited

19,100+