Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
Study NCT ID:
NCT06776692
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-DENV antibodies', 'timeFrame': 'BEFORE administration of the first dose (Time 0 = T0), immediately BEFORE the second dose (Time 2 = T2) of vaccine, and one to two months after the second dose (Time 3 = T3)', 'description': 'Anti-DENV antibodies quantities (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) BEFORE administration of the first dose (T0), immediately BEFORE the second dose (T2) of vaccine, and one to two months after the second dose (T3)'}], 'secondaryOutcomes': [{'measure': 'Innate immunity response', 'timeFrame': 'BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)', 'description': 'Type I and II IFN and IFN-inducible genes, specific cytokines and chemokines induced by Qdenga® vaccine (continuous variables: deltaCt mRNA expression and Optical Density (OD)) at T0 and T1'}, {'measure': 'Cellular response', 'timeFrame': 'At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)', 'description': '1. immunophenotype asset: results of the flow cytometry profiles (proportions of cells),\n2. specific T- and B-cells response to viral peptides: analysis results of T- and B-cells stimulation with DENV specific peptides (continuous variables, unity of measure: Optical Density (OD)) at T0, T2 and T3.'}, {'measure': 'Quantitative and qualitative anti-DENV antibody response', 'timeFrame': 'At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)', 'description': '1. anti-DENV antibodies quantities (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) at T0, T2 and T3,\n2. Analysis results of neutralization assays against different DENV serotypes (continuous variables, unity of measure: TCID50/ml) at T0, T2 and T3,'}, {'measure': 'Humoral response', 'timeFrame': 'At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)', 'description': '1. Analysis results humoral response against different flaviviruses (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) at T0, T2 and T3,\n2. Analysis results of DENV specific avidity assays (unity of measure: Index);\n3. Previous infections with (y/n) or vaccinations against (y/n) other flaviviruses'}, {'measure': 'Cell mediated response', 'timeFrame': 'At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)', 'description': 'Analysis results cell mediated response against different flaviviruses (continuous variables, unity of measure: Optical Density (OD)) at T0, T2 and T3.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dengue', 'Vaccine'], 'conditions': ['Dengue Vaccines']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees.\n\nParticipants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.', 'detailedDescription': 'This is a non-profit, single-center, drug-based observational study whose primary objective is to characterize dengue-specific humoral and cellular immunity induced by the Qdenga® vaccine in vaccinees.\n\nThe study involves the enrollment of all pediatric subjects (age ≥ 4 years) and adults who present themselves at the DITM travel clinic for the administration of the Dengue vaccine; 402 patients are expected to be enrolled and will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years (T4). The samples thus collected will be analyzed for the characterization of innate immunity, the characterization of cellular immunity and the characterization of the humoral response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of both sexes presenting to the DITM to receive the anti-DENV vaccine whether or not they have had a history of prior DENV or other flaviviruses infection or a history of prior vaccination against other flaviviruses. These data will be recorded in the study CRF.\n* Age \\>= 4 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Age \\< 4 years.\n* Absence of signed informed consent.'}, 'identificationModule': {'nctId': 'NCT06776692', 'acronym': 'VaQDENV', 'briefTitle': 'Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Sacro Cuore Don Calabria di Negrar'}, 'officialTitle': 'Characterisation of Dengue Vaccine (Qdenga®, TAK-003)-Induced Humoral and Cellular Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination', 'orgStudyIdInfo': {'id': '2024-L'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine.', 'interventionNames': ['Drug: Qdenga']}], 'interventions': [{'name': 'Qdenga', 'type': 'DRUG', 'description': 'Administration of Dengue vaccine and blood sample collection', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37024', 'city': 'Negrar', 'state': 'VR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Concetta Castilletti', 'role': 'CONTACT', 'email': 'concetta.castilletti@sacrocuore.it', 'phoneExt': '+396013111'}, {'name': 'Concetta Castilletti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Sacro Cuore Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}], 'centralContacts': [{'name': 'Elvia Malo', 'role': 'CONTACT', 'email': 'elvia.malo@sacrocuore.it', 'phone': '+390456013111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Sacro Cuore Don Calabria di Negrar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}