Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-13 @ 10:10 AM
Study NCT ID:
NCT03971058
Status:
UNKNOWN
Last Update Posted:
2019-06-03
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3', 'timeFrame': 'Visit 3 day 42+/-4', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Testing the difference of the JEV antibody titer between young and elderly adults', 'timeFrame': 'Visit 1, day 0) till Visit 4 (day 168 +/- 14)', 'description': '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'}, {'measure': 'Testing cellular immunity', 'timeFrame': 'Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).', 'description': '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.'}, {'measure': 'Testing of lymphocyte populations with FACS analysis', 'timeFrame': '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', 'description': 'Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount'}, {'measure': 'Testing of CMV serology', 'timeFrame': 'Visit 1, day 0', 'description': 'Testing of CMV Seropositivity at the time of the booster vaccination with IXIARO® at Visit 1 (day 0) in both age groups'}, {'measure': 'TBE titer increase/course', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Testing of cellular immunity-Testing of cytokine production', 'timeFrame': 'Visit 1, day 0; Visit 2, day 7 (+2)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Japanese Encephalitis vaccine', 'immune responses'], 'conditions': ['Japanese Encephalitis Vaccine']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nTesting 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.\n\nTesting 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.\n\nTesting TBE-antibody titres before and after JE-booster vaccination (on visit 1-4) in both age groups.\n\nTesting CMV serology at visit 1 in both age groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)\n* willingness to sign written informed consent\n\nmajor Exclusion Criteria:\n\n* Already received an booster (3rd dose) of IXIARO ®\n* Vaccination with other JE vaccine (e.g. Je-vax)\n* clinically manifest infection with another Flavivirus within 1 year prior study inclusion (yellow fever, Dengue fever, West Nile, TBE)\n* past infection with the JEV\n* vaccination against yellow fever, Dengue, West Nile within 6 months prior to study inclusion\n* TBE vaccination within the last 30 days prior to study inclusion\n* 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\n* immunodeficiency or st. p. organ transplantation\n* autoimmune disease except vitiligo or diseases of the thyroid gland with thyroid hormon substitution therapy\n* immuntherapy within 2 weeks before or after Ixiaro Booster\n* current acute infection or exacerbation of a chronic illness\n* cancer within the last 5 years\n* clinically significant haematological, renal, pulmonary, hepatic, neurological, cardiovascular disease which is not treated adequately within 12 weeks before Ixiaro booster\n* known infection with HIV, Hep B and Hep C\n* Guillain - Barré- Syndrome (GBS) - anamnestic\n* anamnestic anaphylaxie, atopy oder severe hypersensivity against ingredients of IXIARO\n* drug abuse/alcohol abuse\n* pregnancy and breastfeeding\n* plasma donation within the last 4 months\n* receiving blood or immunglobulins within 3 months before v1\n* significant mental disorder'}, 'identificationModule': {'nctId': 'NCT03971058', 'briefTitle': 'Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'IXIARO-booster senescence'}, 'secondaryIdInfos': [{'id': '2016-002894-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'young individuals', 'description': 'Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine', 'interventionNames': ['Biological: IXIARO®- Japanese Encephalitis vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'elderly individuals', 'description': 'Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine', 'interventionNames': ['Biological: IXIARO®- Japanese Encephalitis vaccine']}], 'interventions': [{'name': 'IXIARO®- Japanese Encephalitis vaccine', 'type': 'BIOLOGICAL', 'description': 'Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine', 'armGroupLabels': ['elderly individuals', 'young individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Studien Team', 'role': 'CONTACT', 'email': 'isptm-studien@meduniwien.ac.at', 'phone': '+43140160', 'phoneExt': '38276'}, {'name': 'Ines Zwazl, BA', 'role': 'CONTACT', 'email': 'ines.zwazl@meduniwien.ac.at', 'phone': '+43140160', 'phoneExt': '38202'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ursula Wiedermann, MD, PhD', 'role': 'CONTACT', 'email': 'ursula.wiedermann@meduniwien.ac.at', 'phone': '0043 1 40160', 'phoneExt': '38260'}, {'name': 'Ursula Wiedermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Studien Team', 'role': 'CONTACT', 'email': 'isptm-studien@meduniwien.ac.at', 'phone': '+43140160', 'phoneExt': '38276'}, {'name': 'Ines Zwazl, BA', 'role': 'CONTACT', 'email': 'ines.zwazl@meduniwien.ac.at', 'phone': '+43140160', 'phoneExt': '38276'}], 'overallOfficials': [{'name': 'Ursula Wiedermann-Schmidt, Univ Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, ISPTM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Valneva Austria GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. MD PhD', 'investigatorFullName': 'Univ. Prof. Dr. Ursula Wiedermann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}