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出境医 / 临床实验 / Blood Donor CVD 5000

Blood Donor CVD 5000

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE January 16, 2004
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Donor CVD 5000
Official Title  ICMJE Collection of Blood Samples for In-Vitro Studies From Healthy Adult Blood Donors Who Have Received Oral Typhoid Vaccine (TY21A)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Risk Reduction
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Vivotif Typhoid Oral Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robin Barnes, CRNP 410-706-6156 rbarnes@som.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971669
Other Study ID Numbers  ICMJE HP-00040022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marcelo Sztein, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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