Induction of Gut Permeability by an Oral Vaccine (NCT04083950) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Induction of Gut Permeability by an Oral Vaccine
United States10 participantsStarted 2019-12-04
Plain-language summary
This study evaluates the effect of an oral typhoid vaccine on disruption of the intestinal barrier and response of the immune system. Intestinal and whole-body responses will be measured in all participants before and after the vaccine.
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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Inclusion Criteria:
* Body Mass Index (BMI) 18.5 - 29.9 kg/m2
Exclusion Criteria:
* Has HIV/AIDS or another disease that affects the immune system
* Has any kind of cancer
* Decline to take an HIV blood test
* Blood pressure greater than or equal to 140/90 mmhg
* Pregnant or lactating women
* Refusal to take a pregnancy test prior to the study
* Refusal to use a method of birth control during the study
* Allergy to vaccine components, i.e. Thimerosal and enteric-coated capsules
* Allergy to oral typhoid vaccine
* Allergy to aspirin
* Daily use of blood thinners
* Use of anti-inflammatory medications, i.e. nonsteroidal anti-inflammatory drugs (NSAID), aspirin, 3 or more times per month
* Use of sulfonamides or antibiotics in the past 30 days
* Use of anti-hypertensive drugs, i.e. beta blockers, diuretics, calcium channel blockers
* Use of anti-malaria drugs, i.e. Mefloquine, chloroquine, and proguanil
* Use of drugs that affect the immune system, i.e. immunosuppressants, immune-modifying drugs, corticosteroids, i.e. cortisone, prednisone, methylprednisolone, for 2 weeks or longer
* Is taking cancer treatment with radiation or drugs
* Greater than ten years residence in a typhoid-endemic area
* Receipt of typhoid vaccine in the last 5 years
* Receipt of any vaccine two weeks prior to receipt of Ty21a vaccine
* Individuals at increased risk of developing complications from a live, bacterial vaccine
* History of typhoid fever
* History of primary immune deficiency or autoimmun…
What they're measuring
1
Change in intestinal permeability
Timeframe: Day 1, 3, 16, 18, and 22
Trial details
NCT IDNCT04083950
SponsorUSDA, Western Human Nutrition Research Center