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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002894-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Valneva Austria GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| young individuals | Active Comparator | Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine |
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| elderly individuals | Active Comparator | Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IXIARO®- Japanese Encephalitis vaccine | Biological | Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3 | 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) | Visit 3 day 42+/-4 |
| Measure | Description | Time Frame |
|---|---|---|
| Testing the difference of the JEV antibody titer between young and elderly adults | 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 | Visit 1, day 0) till Visit 4 (day 168 +/- 14) |
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Inclusion Criteria:
major Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Studien Team | Contact | +43140160 | 38276 | isptm-studien@meduniwien.ac.at |
| Ines Zwazl, BA | Contact | +43140160 | 38276 | ines.zwazl@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Ursula Wiedermann-Schmidt, Univ Prof MD | Medical University of Vienna, ISPTM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
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| Testing cellular immunity |
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. |
| Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2). |
| Testing of lymphocyte populations with FACS analysis | Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount | 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 CMV serology | Testing of CMV Seropositivity at the time of the booster vaccination with IXIARO® at Visit 1 (day 0) in both age groups | Visit 1, day 0 |
| TBE titer increase/course | 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. | 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 of cellular immunity-Testing of cytokine production | 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 | Visit 1, day 0; Visit 2, day 7 (+2) |
| Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine | Recruiting | Vienna | 1090 | Austria |
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