This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years and older
* Good general health as determined by a screening evaluation within 28 days before blood donation
* Informed, written consent
Exclusion Criteria:
* History of any of the following medical illnesses:
* Diabetes
* Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
* Heart disease (Hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart disease - dyspnea, angina, orthopnea)
* Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
* Current drug or alcohol abuse
* Active ulcer disease or ongoing intestinal condition
* Treatment for anemia in last 6 months
* Currently being treated with anti-malarial drugs
* Any of the following laboratory abnormalities detected during medical screening:
* WBC \<0.81 x LLN or \> 1.09 x ULN
* Hemoglobin \<0.91 x LLN or \>1.18 x ULN (women) or \<0.92 x LLN or \>1.18 x ULN (men)
* Platelet count \<0.8 x LLN or \> 1.2 x ULN
* (For leukopheresis or blood unit donations, the following lab values are exclusionary:
* WBC \<3.5 or \>11 x 103/mm3;
* Hemoglobin \<12.5 or \>18 g/dl
* Platelet count \<150 or \>500 x 103/mm3)
* SGOT or SGPT \>1.5 times normal
* Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
* Positive serology for hepatitis B core antib…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.