Blood Donor CVD 5000

ConditionRisk Reduction

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Maryland, Baltimore

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years and older

Good general health as determined by a screening evaluation within 28 days before blood donation

Informed, written consent

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Vivotif Typhoid Oral Vaccine
Drug
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).

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Vaccination with Oral Typhoid Vaccine (Vivotif)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage of Responders

Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of \>0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.

Time frame

approximately 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

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