Vivotif Vaccine for Typhoid Risk Reduction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a vaccine called Vivotif, designed to prevent typhoid, a serious illness that spreads through contaminated food and water. Researchers aim to understand how this vaccine aids the immune system in fighting typhoid and possibly other similar diseases. Participants will provide samples, such as blood and saliva, over several years to gather this information. Those in good health without issues like diabetes or heart problems in the past five years may be suitable for this trial. As a Phase 4 trial, the treatment has FDA approval and proven effectiveness, and this research seeks to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are currently being treated with anti-malarial drugs, you would be excluded from participating.
What is the safety track record for the Vivotif Typhoid Oral Vaccine?
Research has shown that the Vivotif oral typhoid vaccine is very safe and easy to handle. Studies have found that side effects are rare and usually mild. Most side effects, such as an upset stomach or headache, resolve on their own. The FDA has already approved Vivotif for travelers, indicating it has been tested and used widely, which adds to the confidence in its safety.12345
Why are researchers enthusiastic about this study treatment?
Unlike the standard injectable vaccines for typhoid, Vivotif is unique because it is an oral vaccine, which makes it easier to administer and potentially more appealing to people who are needle-averse. This oral vaccine contains live attenuated bacteria, which can stimulate a robust immune response. Researchers are excited about Vivotif because it has the potential to offer effective protection against typhoid fever through a simpler, less invasive method compared to traditional shots.
What is the effectiveness track record for the Vivotif Typhoid Oral Vaccine?
Research shows that the Vivotif oral vaccine, which participants in this trial will receive, helps protect against typhoid fever. Studies indicate that it benefits adults and children over six years old. The vaccine has proven to be 45% effective in preventing typhoid fever. For travelers, this moderate effectiveness supports its use and aligns with vaccination guidelines. This evidence highlights the vaccine's ability to lower the risk of typhoid, especially for those visiting areas where the disease is more common.12678
Are You a Good Fit for This Trial?
Adults over 18 in good health can join this trial. They must not have heart disease, active ulcers, intestinal conditions, recent anemia treatment, substance abuse issues, diabetes or recent cancer (except certain skin and cervical cancers). Blood tests will exclude those with abnormal blood counts or liver function, hepatitis B/C or HIV infections. Pregnant women and those on anti-malarial drugs cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Volunteers receive immunization with Vivotif oral typhoid vaccine
Specimen Collection
Blood, saliva, and stool specimens are collected at subsequent visits
Follow-up
Participants are monitored for safety and effectiveness after vaccination
What Are the Treatments Tested in This Trial?
Interventions
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor