RECRUITING

Blood Donor CVD 5000

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)

Quick Facts

Study Start:2004-01-16
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03971669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older
  2. * Good general health as determined by a screening evaluation within 28 days before blood donation
  3. * Informed, written consent
  1. * History of any of the following medical illnesses:
  2. * Diabetes
  3. * Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
  4. * 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)
  5. * Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
  6. * Current drug or alcohol abuse
  7. * Active ulcer disease or ongoing intestinal condition
  8. * Treatment for anemia in last 6 months
  9. * Currently being treated with anti-malarial drugs
  10. * Any of the following laboratory abnormalities detected during medical screening:
  11. * WBC \<0.81 x LLN or \> 1.09 x ULN
  12. * Hemoglobin \<0.91 x LLN or \>1.18 x ULN (women) or \<0.92 x LLN or \>1.18 x ULN (men)
  13. * Platelet count \<0.8 x LLN or \> 1.2 x ULN
  14. * (For leukopheresis or blood unit donations, the following lab values are exclusionary:
  15. * WBC \<3.5 or \>11 x 103/mm3;
  16. * Hemoglobin \<12.5 or \>18 g/dl
  17. * Platelet count \<150 or \>500 x 103/mm3)
  18. * SGOT or SGPT \>1.5 times normal
  19. * Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
  20. * Positive serology for hepatitis B core antibody
  21. * Poor peripheral venous access for blood donation
  22. * Positive RPR
  23. * Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study.
  24. * Positive urine pregnancy test (HCG) on day of vaccination. Prior to each blood donation -females with menstrual history consistent with pregnancy. Pregnant women will not be enrolled, because immunological changes that occur during pregnancy may interfere with laboratory assays.

Contacts and Locations

Study Contact

Susan Holian, RN
CONTACT
410-706-6156
susan.holian@som.umaryland.edu

Study Locations (Sites)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2004-01-16
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2004-01-16
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Typhoid

Additional Relevant MeSH Terms

  • Risk Reduction