Typhoid Vaccine for Gut Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how an oral typhoid vaccine affects the gut and immune system. Researchers aim to determine if the vaccine can protect the intestinal barrier and measure changes in the body's immune response. All participants will receive the Vivotif Typhoid Oral Vaccine along with aspirin to assess these effects. Individuals with a BMI between 18.5 and 29.9 who have not had recent vaccines, typhoid exposure, or chronic conditions affecting their immune or digestive systems may be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical research.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes people using blood thinners, anti-inflammatory drugs, antibiotics, anti-hypertensive drugs, anti-malaria drugs, and drugs that affect the immune system. If you're on any of these, you might need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the Vivotif Typhoid Oral Vaccine is generally safe. In past studies, most participants did not experience serious side effects. The most common issues were mild, such as stomach pain, nausea, and headache, and these usually resolved on their own.
The FDA has approved the vaccine to prevent typhoid fever, confirming its safety for this purpose. Although it doesn't offer complete protection against typhoid, its safety is well-documented. While mild discomfort may occur, serious problems are rare.12345Why do researchers think this study treatment might be promising?
Unlike the standard typhoid vaccines, which are typically injected, the Vivotif Typhoid Oral Vaccine is taken by mouth. This oral delivery method makes it easier and more convenient for people to take, especially for those who might be uneasy about needles. Additionally, Vivotif is a live attenuated vaccine, which means it uses a weakened form of the typhoid bacteria to stimulate immunity. Researchers are excited about this approach because it could enhance gut health by directly targeting the gut, where the typhoid bacteria primarily cause infection.
What evidence suggests that the Vivotif Typhoid Oral Vaccine might be an effective treatment for gut health?
Research shows that the Vivotif Typhoid Oral Vaccine can protect adults and children over six from typhoid fever. Studies have found that the vaccine's effectiveness varies, with some studies showing protection for up to 78% of people. The vaccine might also affect the gut by altering immune responses, but this is still under investigation. This suggests the vaccine could do more than just prevent typhoid fever; it might also impact gut health and immune function. However, it is important to remember that while the vaccine is effective, it does not provide complete protection against typhoid fever.13678
Who Is on the Research Team?
Danielle Lemay, PhD
Principal Investigator
USDA, ARS, Western Human Nutrition Research Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Measurement
Baseline gut permeability and immune response measurements are taken before vaccination
Treatment
Participants receive the Ty21a oral typhoid vaccine and aspirin, with gut permeability and immune response measured after each dose
Follow-up
Participants are monitored for immune response and changes in gut permeability after the final vaccine dose
What Are the Treatments Tested in This Trial?
Interventions
- Aspirin
- Vivotif Typhoid Oral Vaccine
Vivotif Typhoid Oral Vaccine is already approved in United States for the following indications:
- 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
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Who Is Running the Clinical Trial?
USDA, Western Human Nutrition Research Center
Lead Sponsor