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Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine

Primary Purpose

Humoral and Cellular Immune Responses

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
IXIARO
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Humoral and Cellular Immune Responses

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults (18-40 years old)
  • adults (≥60 years),
  • both sexes
  • willingness to sign written informed consent form

Exclusion Criteria:

  • age below 18 years or between 41-59 years old
  • status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
  • previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
  • current acute infection (body temperature above 37,9°C)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    elderly

    young

    Arm Description

    subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO

    subjects 18 to 40 years old, receiving 2 immunisations with IXIARO

    Outcomes

    Primary Outcome Measures

    cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination

    Secondary Outcome Measures

    Full Information

    First Posted
    July 19, 2011
    Last Updated
    March 26, 2018
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01398540
    Brief Title
    Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine
    Official Title
    Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Humoral and Cellular Immune Responses

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    elderly
    Arm Type
    Experimental
    Arm Description
    subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO
    Arm Title
    young
    Arm Type
    Experimental
    Arm Description
    subjects 18 to 40 years old, receiving 2 immunisations with IXIARO
    Intervention Type
    Biological
    Intervention Name(s)
    IXIARO
    Intervention Description
    2 immunizations (0,5ml) with a 28 day interval
    Primary Outcome Measure Information:
    Title
    cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
    Time Frame
    7 days after the 2 JE vaccinations

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adults (18-40 years old) adults (≥60 years), both sexes willingness to sign written informed consent form Exclusion Criteria: age below 18 years or between 41-59 years old status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection previous immunization against yellow fever, japanese encephalitis (dengue or WNV) current acute infection (body temperature above 37,9°C)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ursula Wiedermann, MD, PhD
    Organizational Affiliation
    Institute of Specific Prophylaxis and Tropical medicine, Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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