Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)
University of Maryland, Baltimore
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 ho…
Interventions
- DrugVivotif Typhoid Oral Vaccine
The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
Location
- University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimore, Maryland