Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT03971669

Blood Donor CVD 5000

Led by University of Maryland, Baltimore · Updated on 2026-03-27

150

Participants Needed

1

Research Sites

1380 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Blood Donor CVD 5000

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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, bypass surgery, arrhythmia, or syncope within past 5 years
  • Current symptoms of heart disease such as dyspnea, angina, or orthopnea
  • Recurrent infections with more than 3 hospitalizations for invasive bacterial infections like 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
  • White blood cell count outside specified normal limits
  • Hemoglobin outside specified normal limits
  • Platelet count outside specified normal limits
  • Abnormal liver enzymes (SGOT or SGPT greater than 1.5 times normal)
  • Positive serology for hepatitis C, HIV antibody, hepatitis B surface antigen, or hepatitis B core antibody
  • Poor peripheral venous access for blood donation
  • Positive Rapid Plasma Reagin (RPR) test
  • Any condition that would jeopardize volunteer safety or study integrity
  • Positive urine pregnancy test on day of vaccination or pregnancy indicated by menstrual history prior to blood donation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

S

Susan Holian, RN

CONTACT

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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