Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT04083950
Eligibility Criteria:
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 autoimmune disease
* History of acute or chronic gastrointestinal (GI) disorder, i.e. Crohn's disease, irritable bowel syndrome, gastric ulcer
* Diarrheal illness (defined as passing 3 or more abnormally loose or watery stool in a 24 hour period) or persistent vomiting 2 weeks prior to the study
* History of bleeding disorder, including bleeding from the GI tract
* History of chronic illnesses, i.e. diabetes, cardiovascular disease, cancer, gastrointestinal malabsorption or inflammatory diseases, kidney disease, autoimmune disorders, HIV, liver disease, including hepatitis B and C.
* Asthma if taking medication on a daily basis
* Recent surgery (within 3 months)
* History of GI surgery
* Recent hospitalization (within 3 months)
* Acute febrile illness (within 2 weeks)
* Unwillingness to discontinue consumption of artificial sweeteners in foods or drinks, i.e. sport drinks, coconut water, "diet" drinks and foods (possibly containing sucralose)
* Not having at least one arm vein suitable for blood drawing
* Unwilling or uncomfortable with blood draws seven times in 29 days
* Regular blood or blood product donation and refusal to suspend donation
* Current participation in another research study
* Unable to fast for 12-16 hours
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT04083950
Study Brief:
Protocol Section:
NCT04083950