Japanese Encephalitis Vaccine
Conditions
Keywords
Japanese Encephalitis vaccine, immune responses
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.
Interventions
BIOLOGICALIXIARO®- Japanese Encephalitis vaccine
Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
Sponsors
Valneva Austria GmbH
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 60. * good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM) * willingness to sign written informed consent major
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| Testing cellular immunity | Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2). | Testing cellular immunity (cytokine production of IL-2, IFN-g, TNF-alpha, IL-6, IL-10, IL-21 after stimulation with JEV antigen) before the booster vaccination with IXIARO® (Visit 1, day 0), seven days (Visit 2, day 7 (+2) after and after 42 days (Visit 3, day 42 (+/-4)) after that in comparison between the age groups. |
| 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 lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount |
| Testing the difference of the JEV antibody titer between young and elderly adults | Visit 1, day 0) till Visit 4 (day 168 +/- 14) | Testing the difference of the JEV antibody titer before the booster vaccination with IXIARO® (Visite 1, day 0) till Visit 4 (day 168 +/- 14) in comparison between the age groups |
| 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) | Tick borne encephalitis titer before booster vaccination with IXIARO® (Visit 1, day 0), seven days after the booster vaccination (Visit 2, day 7 (+2),and 42 days (Visit 3, day 42 (+/-4) after the booster vaccination and 6 months (Visit 4, day 168 (+/- 14) after the booster vaccination and the in comparison between age groups. |
| Testing of cellular immunity-Testing of cytokine production | Visit 1, day 0; Visit 2, day 7 (+2) | Testing of cellular immunity (cytokine production of IL-2, TNF-alpha, IL-6, IL-10 after stimulation mit TBE Antigen) before and seven days after the booster vaccination with IXIARO® (Visit 1, day 0; Visit 2, day 7 (+2) in comparison between the age groups |
| Testing of CMV serology | Visit 1, day 0 | Testing of CMV Seropositivity at the time of the booster vaccination with IXIARO® at Visit 1 (day 0) in both age groups |
Countries
Austria
Contacts
Primary ContactStudien Team
Backup ContactInes Zwazl, BA
Outcome results
None listed