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
About this trial
This is an interventional basic science trial for Humoral and Cellular Immune Responses
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)
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
NCT ID
NCT01398540
First Posted
July 19, 2011
Last Updated
March 26, 2018
Sponsor
Medical University of Vienna
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
Learn more about this trial
Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine
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