Characterisation of Cellular and Humoral Immune Responses Following the First Booster Immunisation With the Inactivated, Purified Japanese Encephalitis Vaccine IXIARO® in Elderly Compared to Young Individuals.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Medical University of Vienna
- Enrollment
- 64
- Locations
- 4
- Primary Endpoint
- JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3
Study Overview
Brief Summary
The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.
Detailed Description
The condition under investigation is the naturally aging immune system. The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.Testing the difference of the JEV-antibody titre increase between young and elderly adults between visit 1 (before booster vaccination) and up to visit 4 (6 months after booster vaccination).
Testing cellular immunity (cytokine production after JEV as well as TBE stimulation) on visit 1, 2 (one week after booster immunisation) and 3 between both age groups.
Testing of surface markers of different T and B cell subsets before and after JE-booster vaccination (on visit 1-3) in comparison between both age groups.
Testing TBE-antibody titres before and after JE-booster vaccination (on visit 1-4) in both age groups.
Testing CMV serology at visit 1 in both age groups.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •participation in the preceeding study "IXIARO®-senescence" (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of
- •good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)
- •willingness to sign written informed consent
Exclusion Criteria
- •Already received an booster (3rd dose) of IXIARO ®
- •Vaccination with other JE vaccine (e.g. Je-vax)
- •clinically manifest infection with another Flavivirus within 1 year prior study inclusion (yellow fever, Dengue fever, West Nile, TBE)
- •past infection with the JEV
- •vaccination against yellow fever, Dengue, West Nile within 6 months prior to study inclusion
- •TBE vaccination within the last 30 days prior to study inclusion
- •immunosuppressive therapy (intake>14d) within 30 days before IXIARO booster till V3 (day 42+/-4), Corticosteroids like Prednisolon > and = 20mg/day; allowed: topic or inhalative application
- •immunodeficiency or st. p. organ transplantation
- •autoimmune disease except vitiligo or diseases of the thyroid gland with thyroid hormon substitution therapy
- •immuntherapy within 2 weeks before or after Ixiaro Booster
- •current acute infection or exacerbation of a chronic illness
- •cancer within the last 5 years
- •clinically significant haematological, renal, pulmonary, hepatic, neurological, cardiovascular disease which is not treated adequately within 12 weeks before Ixiaro booster
- •known infection with HIV, Hep B and Hep C
- •Guillain - Barré- Syndrome (GBS) - anamnestic
- •anamnestic anaphylaxie, atopy oder severe hypersensivity against ingredients of IXIARO
- •drug abuse/alcohol abuse
- •pregnancy and breastfeeding
- •plasma donation within the last 4 months
- •receiving blood or immunglobulins within 3 months before v1
- •significant mental disorder
Arms & Interventions
young individuals
Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
Intervention: IXIARO®- Japanese Encephalitis vaccine (Biological)
elderly individuals
Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
Intervention: IXIARO®- Japanese Encephalitis vaccine (Biological)
Outcomes
Primary Outcomes
JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3
Time Frame: Visit 3 day 42+/-4
Testing the difference of the JEV antibodies increase between young and elderly adults between Visit 1 (before booster vaccination) and Visit 3 (day 42+/-4 after Booster vaccination)
Secondary Outcomes
- Testing of lymphocyte populations with FACS analysis(Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2) and 42 days (Visit 3, day 42 (+/-4) after booster vaccination)
- Testing of cellular immunity-Testing of cytokine production(Visit 1, day 0; Visit 2, day 7 (+2))
- Testing of CMV serology(Visit 1, day 0)
- TBE titer increase/course(Visit 1, day 0), seven days (Visit 2, day 7 (+2), 42 days (Visit 3, day 42 (+/-4) und 6 Months (Visit 4, day 168 (+/- 14))
- Testing the difference of the JEV antibody titer between young and elderly adults(Visit 1, day 0) till Visit 4 (day 168 +/- 14))
- Testing cellular immunity(Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).)
Investigators
Univ. Prof. Dr. Ursula Wiedermann
Univ.-Prof. MD PhD
Medical University of Vienna