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Blood Donor CVD 5000

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ClinicalTrials.gov Identifier: NCT03971669
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Marcelo Sztein, University of Maryland, Baltimore

Brief 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.

Condition or disease Intervention/treatment Phase
Risk Reduction Drug: Vivotif Typhoid Oral Vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Typhoid Vaccine (Vivotif).
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)
Actual Study Start Date : January 16, 2004
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccination with Oral Typhoid Vaccine (Vivotif)
Volunteers receive immunization with Vivotif oral typhoid vaccine. Blood, saliva, and stool specimens are collected at subsequent visits.
Drug: Vivotif 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).
Other Name: Ty21a Typhoid Oral Vaccine




Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: approximately 5 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 hospitalizations for invasive bacterial infections such as 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
  • Any of the following laboratory abnormalities detected during medical screening:

    • WBC <0.81 x LLN or > 1.09 x ULN
    • Hemoglobin <0.91 x LLN or >1.18 x ULN (women) or <0.92 x LLN or >1.18 x ULN (men)
    • Platelet count <0.8 x LLN or > 1.2 x ULN
    • (For leukopheresis or blood unit donations, the following lab values are exclusionary:
    • WBC <3.5 or >11 x 103/mm3;
    • Hemoglobin <12.5 or >18 g/dl
    • Platelet count <150 or >500 x 103/mm3)
    • SGOT or SGPT >1.5 times normal
    • Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
    • Positive serology for hepatitis B core antibody
    • Poor peripheral venous access for blood donation
    • Positive RPR
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971669


Contacts
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Contact: Robin Barnes, CRNP 410-706-6156 rbarnes@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland, Baltimore, Center for Vaccine Development and Global Health Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robin Barnes, CRNP    410-706-6156    rbarnes@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
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Responsible Party: Marcelo Sztein, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03971669    
Other Study ID Numbers: HP-00040022
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcelo Sztein, University of Maryland, Baltimore:
Typhoid
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs