Actively Recruiting
Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)
Led by University of Maryland, Baltimore · Updated on 2026-03-27
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, non-randomized study to evaluate the immune response triggered by the oral typhoid vaccine, Vivotif. This vaccine has been approved by the FDA for travelers to developing countries. The study aims to improve understanding of the protective immune mechanisms activated systemically, which might also apply to other intestinal infections. Participants will receive four doses of the Vivotif oral typhoid vaccine, each given as one capsule on alternate days (days 0, 2, 4, and 7) under supervision. After vaccination, blood, saliva, and stool samples will be collected during follow-up visits lasting up to eight years to monitor immune responses. During the study, volunteers will provide specimens for laboratory analysis to measure the percentage of responders approximately five years after vaccination. The research includes regular health screenings and monitoring to ensure participant safety. The total involvement may last up to eight years, allowing for long-term observation of the vaccine's immunological effects.
CONDITIONS
Brief Title
Blood Donor CVD 5000
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Good general health as determined by a screening evaluation within 28 days before blood donation
- Informed, written consent
You will not qualify if you...
- History of diabetes
- Cancer in past 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- Heart disease including hospitalization for heart attack, coronary artery bypass, arrhythmia, or syncope within past 5 years or current symptoms
- Recurrent infections with more than 3 hospitalizations for invasive bacterial infections
- Current drug or alcohol abuse
- Active ulcer disease or ongoing intestinal condition
- Treatment for anemia in last 6 months
- Currently treated with anti-malarial drugs
- Laboratory abnormalities outside specified ranges for WBC, hemoglobin, platelet count
- Elevated SGOT or SGPT above 1.5 times normal
- Positive serology for hepatitis B, C, HIV, or positive RPR
- Poor peripheral venous access for blood donation
- Any condition that may jeopardize safety or scientific integrity
- Positive urine pregnancy test on day of vaccination or pregnancy indicated prior to blood donation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days before vaccination
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 week
Participants receive 4 doses of the oral typhoid vaccine on alternate days under supervision. Blood, saliva, and stool specimens are collected at visits following vaccination.
4 visits (in-person) for vaccination and specimen collection
Trial Site Locations
Total: 1 location
1
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
S
Susan Holian, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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