Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 8:03 AM
Study NCT ID:
NCT02511535
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Sponsor:
Organization:
Raw JSON
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Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erika.garner-spitzer@meduniwien.ac.at', 'phone': '0043 1 40160', 'title': 'Erika Garner-Spitzer, PhD', 'phoneExt': '38255', 'organization': 'Med Uni Wien, Institut für Spezifische Prophylaxe und Tropenmedizin'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 23, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 12, 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'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination'}, {'id': 'OG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'Healthy controls receive TBE booster vaccination'}], 'classes': [{'categories': [{'measurements': [{'value': '317.90', 'groupId': 'OG000', 'lowerLimit': '238.70', 'upperLimit': '423.30'}, {'value': '250.10', 'groupId': 'OG001', 'lowerLimit': '143.90', 'upperLimit': '434.40'}, {'value': '282.20', 'groupId': 'OG002', 'lowerLimit': '210.60', 'upperLimit': '378.20'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'one month after booster vaccination', 'description': 'Geometric mean titers of TBE specific neutralizing Abs', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cellular Immune Response - Cytokine Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination'}, {'id': 'OG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'Healthy controls receive TBE booster vaccination'}], 'classes': [{'title': 'IFNg before vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.85', 'groupId': 'OG000', 'lowerLimit': '25.86', 'upperLimit': '55.39'}, {'value': '42.54', 'groupId': 'OG001', 'lowerLimit': '23.36', 'upperLimit': '77.49'}, {'value': '38.91', 'groupId': 'OG002', 'lowerLimit': '25.13', 'upperLimit': '59.01'}]}]}, {'title': 'IFNg 1 week post vacc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.19', 'groupId': 'OG000', 'lowerLimit': '37.61', 'upperLimit': '78.08'}, {'value': '59.45', 'groupId': 'OG001', 'lowerLimit': '32.67', 'upperLimit': '108.17'}, {'value': '77.27', 'groupId': 'OG002', 'lowerLimit': '52.26', 'upperLimit': '114.25'}]}]}, {'title': 'IL-10 before vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.21', 'groupId': 'OG000', 'lowerLimit': '25.90', 'upperLimit': '47.86'}, {'value': '38.86', 'groupId': 'OG001', 'lowerLimit': '23.75', 'upperLimit': '63.58'}, {'value': '30.28', 'groupId': 'OG002', 'lowerLimit': '21.15', 'upperLimit': '43.37'}]}]}, {'title': 'IL-10 one week post vacc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.90', 'groupId': 'OG000', 'lowerLimit': '36.60', 'upperLimit': '65.33'}, {'value': '52.13', 'groupId': 'OG001', 'lowerLimit': '37.00', 'upperLimit': '73.44'}, {'value': '52.28', 'groupId': 'OG002', 'lowerLimit': '36.47', 'upperLimit': '74.95'}]}]}, {'title': 'IL-2 before vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.62', 'groupId': 'OG000', 'lowerLimit': '36.54', 'upperLimit': '75.78'}, {'value': '35.41', 'groupId': 'OG001', 'lowerLimit': '21.25', 'upperLimit': '59.02'}, {'value': '37.20', 'groupId': 'OG002', 'lowerLimit': '24.43', 'upperLimit': '56.64'}]}]}, {'title': 'IL-2 one week post vacc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.80', 'groupId': 'OG000', 'lowerLimit': '37.03', 'upperLimit': '78.18'}, {'value': '37.11', 'groupId': 'OG001', 'lowerLimit': '24.44', 'upperLimit': '56.34'}, {'value': '51.07', 'groupId': 'OG002', 'lowerLimit': '34.57', 'upperLimit': '75.44'}]}]}, {'title': 'IL-5 before vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.40'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '1.85', 'upperLimit': '1.85'}, {'value': '2.04', 'groupId': 'OG002', 'lowerLimit': '1.87', 'upperLimit': '2.23'}]}]}, {'title': 'IL-5 one week post vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '2.32', 'upperLimit': '3.77'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '1.90'}, {'value': '2.85', 'groupId': 'OG002', 'lowerLimit': '2.23', 'upperLimit': '3.64'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'before (day 0) and 1week after booster vaccination', 'description': 'cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'the missing cytokine concentrations were not used for calculation because of invalid positive controls (due to poor PBMC \\[peripheral blood mononuclear cell\\] viability)'}, {'type': 'SECONDARY', 'title': 'Cellular Immune Response - Lymphocyte Subpopulations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination'}, {'id': 'OG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'Healthy controls receive TBE booster vaccination'}], 'classes': [{'title': 'T cells (CD3 +) at day 0', 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '71.8'}, {'value': '73.7', 'groupId': 'OG001', 'lowerLimit': '70.9', 'upperLimit': '76.5'}, {'value': '68.2', 'groupId': 'OG002', 'lowerLimit': '65.5', 'upperLimit': '71.0'}]}]}, {'title': 'T cells (CD3 +) 1 week after booster vaccination', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '71.2'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '77.1'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '68.3', 'upperLimit': '72.9'}]}]}, {'title': 'B cells (CD19 +) at day 0', 'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '8.57'}, {'value': '7.01', 'groupId': 'OG001', 'lowerLimit': '6.04', 'upperLimit': '7.98'}, {'value': '7.11', 'groupId': 'OG002', 'lowerLimit': '6.34', 'upperLimit': '7.89'}]}]}, {'title': 'B cells (CD19 +) 1 week after booster vaccination', 'categories': [{'measurements': [{'value': '7.22', 'groupId': 'OG000', 'lowerLimit': '6.33', 'upperLimit': '8.11'}, {'value': '6.34', 'groupId': 'OG001', 'lowerLimit': '5.34', 'upperLimit': '7.34'}, {'value': '6.39', 'groupId': 'OG002', 'lowerLimit': '5.78', 'upperLimit': '7.01'}]}]}, {'title': 'T helper cells (CD4 +) at day 0', 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '39.9', 'upperLimit': '44.6'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '45.5', 'upperLimit': '52.4'}, {'value': '41.6', 'groupId': 'OG002', 'lowerLimit': '38.7', 'upperLimit': '44.4'}]}]}, {'title': 'T helper cells (CD4 +) 1 week after booster', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '45.0'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '53.4'}, {'value': '43.0', 'groupId': 'OG002', 'lowerLimit': '40.1', 'upperLimit': '45.8'}]}]}, {'title': 'cytotoxic T cells (CD8 +) at day 0', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '19.8', 'upperLimit': '23.3'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '23.4'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '18.4', 'upperLimit': '22.8'}]}]}, {'title': 'cytotoxic T cells (CD8 +) 1 week after booster', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '22.6'}, {'value': '20.7', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '23.8'}, {'value': '21.2', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '23.3'}]}]}, {'title': 'Tregs (CD4+ FOXP3+) at day 0', 'categories': [{'measurements': [{'value': '4.65', 'groupId': 'OG000', 'lowerLimit': '4.20', 'upperLimit': '5.13'}, {'value': '5.36', 'groupId': 'OG001', 'lowerLimit': '4.61', 'upperLimit': '6.16'}, {'value': '4.49', 'groupId': 'OG002', 'lowerLimit': '4.10', 'upperLimit': '4.89'}]}]}, {'title': 'Tregs (CD4+ FOXP3+) 1 week after booster', 'categories': [{'measurements': [{'value': '4.54', 'groupId': 'OG000', 'lowerLimit': '4.10', 'upperLimit': '5.01'}, {'value': '5.60', 'groupId': 'OG001', 'lowerLimit': '4.93', 'upperLimit': '6.30'}, {'value': '4.21', 'groupId': 'OG002', 'lowerLimit': '3.84', 'upperLimit': '4.60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before (day 0) and 1week after booster vaccination', 'description': 'analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes', 'unitOfMeasure': 'percent of total lymphocytes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TBE Titer Course', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination'}, {'id': 'OG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'Healthy controls receive TBE booster vaccination'}], 'classes': [{'title': 'fold change 1 week after booster', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.73'}, {'value': '1.80', 'groupId': 'OG001', 'lowerLimit': '1.36', 'upperLimit': '2.37'}, {'value': '1.79', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '2.14'}]}]}, {'title': 'fold change 4 weeks after booster', 'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '3.77'}, {'value': '3.01', 'groupId': 'OG001', 'lowerLimit': '2.05', 'upperLimit': '4.41'}, {'value': '2.56', 'groupId': 'OG002', 'lowerLimit': '2.09', 'upperLimit': '3.13'}]}]}, {'title': 'fold change 6 month after booster', 'categories': [{'measurements': [{'value': '1.95', 'groupId': 'OG000', 'lowerLimit': '1.54', 'upperLimit': '2.46'}, {'value': '2.53', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '3.54'}, {'value': '1.79', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '2.29'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before (day 0) until 6 months after booster vaccination', 'description': 'Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination', 'unitOfMeasure': 'fold change from d0 (before booster)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination\n\nTBE booster vaccination'}, {'id': 'FG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination\n\nTBE booster vaccination'}, {'id': 'FG002', 'title': 'Healthy Controls', 'description': 'Healthy controls receive TBE booster vaccination\n\nTBE booster vaccination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Allergic Patients', 'description': 'Allergic patients receive TBE booster vaccination'}, {'id': 'BG001', 'title': 'Allergic Patients With De-sensitization Treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination'}, {'id': 'BG002', 'title': 'Healthy Controls', 'description': 'Healthy controls receive TBE booster vaccination'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2015-07-23', 'resultsFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-03', 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Humoral TBE Immunity', 'timeFrame': 'one month after booster vaccination', 'description': 'Geometric mean titers of TBE specific neutralizing Abs'}], 'secondaryOutcomes': [{'measure': 'Cellular Immune Response - Cytokine Production', 'timeFrame': 'before (day 0) and 1week after booster vaccination', 'description': 'cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)'}, {'measure': 'Cellular Immune Response - Lymphocyte Subpopulations', 'timeFrame': 'before (day 0) and 1week after booster vaccination', 'description': 'analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes'}, {'measure': 'TBE Titer Course', 'timeFrame': 'before (day 0) until 6 months after booster vaccination', 'description': 'Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vaccine Responsiveness in Allergy', 'Vaccine Responsiveness During Allergy De-sensitization Treatment']}, 'referencesModule': {'references': [{'pmid': '29673942', 'type': 'DERIVED', 'citation': 'Garner-Spitzer E, Seidl-Friedrich C, Zwazl I, Hofer M, Kinaciyan T, Jarisch R, Stiasny K, Zlabinger GJ, Kundi M, Wiedermann U. Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias. Vaccine. 2018 May 11;36(20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076. Epub 2018 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations.', 'detailedDescription': 'Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune suppressive cytokines. The investigators measure humoral and cellular immune responses to routine vaccination (Tick-borne Encephalitis \\[TBE\\] booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* completed primary TBE immunization + at least one booster immunization\n* adults of both sexes between 18 and 60 years of age\n* willingness to sign written informed consent form\n\nExclusion Criteria:\n\n* age \\< 18 and \\> 60 years\n* prior TBE infection\n* Hepatitis A vaccination\n* pregnancy and breast feeding\n* acute infection on day of inclusion (day 0), body temperature \\>37,9°C\n* concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study\n* administration of other vaccines 4 weeks before/after TBE vaccination\n* planned surgery within 2 weeks before/after TBE vaccination\n* Start of de-sensitization and the first 4 weeks of allergen dose escalation\n* any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions\n* history of malignant disease within the last 5 years\n* autoimmune diseases\n* drug addictions\n* plasma donors\n* receipt of blood transfusions or immuno globulins within 3 month before study entry"}, 'identificationModule': {'nctId': 'NCT02511535', 'briefTitle': 'TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients', 'orgStudyIdInfo': {'id': 'TBE_1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allergic patients', 'description': 'Allergic patients receive TBE booster vaccination', 'interventionNames': ['Biological: TBE booster vaccination']}, {'type': 'EXPERIMENTAL', 'label': 'Allergic patients with de-sensitization treatment', 'description': 'Allergic patients with de-sensitization treatment receive TBE booster vaccination', 'interventionNames': ['Biological: TBE booster vaccination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'Healthy controls receive TBE booster vaccination', 'interventionNames': ['Biological: TBE booster vaccination']}], 'interventions': [{'name': 'TBE booster vaccination', 'type': 'BIOLOGICAL', 'otherNames': ['Vaccine: FSME-Immun® (Fruehsommer-Meningoencephalitis)', 'One dose (0.5 ml) contains:', '2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudoerfl),', 'adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+)', 'Manufacturer: Baxter Innovations GmbH'], 'armGroupLabels': ['Allergic patients', 'Allergic patients with de-sensitization treatment', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Ursula Wiedermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. Ursula Wiedermann, MD, PhD', 'investigatorFullName': 'Univ. Prof. Dr. Ursula Wiedermann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}