Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:30 AM
Study NCT ID:
NCT07347002
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-11
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Assess the Effectiveness of VLA1553 Vaccine in Preventing Chikungunya During a Pilot Vaccination Strategy in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065632', 'term': 'Chikungunya Fever'}], 'ancestors': [{'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated individuals with CHIKV-like symptoms confirmed by RT-PCR, stratified by sex and age group (≥18 to 59 and ≥ 60 years, depending on the age group approved for the PVS)', 'timeFrame': 'Study start through study completion, an average of 23 months'}, {'measure': 'Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals with CHIKV-like symptoms confirmed by RT-PCR, stratified by time since vaccination (from 0 to 6 months after Day 15)', 'timeFrame': 'Study start through study completion, an average of 23 months'}, {'measure': 'CHIKV hospitalizations (confirmed by RT-PCR) in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals; CHIKV deaths (confirmed by RT-PCR) in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals', 'timeFrame': 'Study start through study completion, an average of 23 months'}, {'measure': 'Magnitude and direction of estimated level of bias due to unmeasured pre-vaccination strategy CHIKV infection, and estimated VE corrected for this bias.', 'timeFrame': 'Study start through study completion, an average of 23 months'}], 'primaryOutcomes': [{'measure': 'Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals with CHIKV-like symptoms confirmed by reverse transcriptase polymerase chain reaction (RT-PCR).', 'timeFrame': 'Study start through study completion, an average of 23 months'}], 'secondaryOutcomes': [{'measure': 'Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals ≥50 years of age with CHIKV-like symptoms confirmed by RT-PCR.', 'timeFrame': 'Study start through study completion, an average of 23 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chikungunya Virus Infection']}, 'descriptionModule': {'briefSummary': 'This is an observational, non-interventional, test-negative case-control (TNCC) study to estimate the vaccine effectiveness of VLA1553 against Chikungunya virus in a real-world setting.', 'detailedDescription': 'The objective of this study is to evaluate the effectiveness of vaccination with VLA1553 in the prevention of laboratory-confirmed symptomatic cases of CHIK after a single dose of VLA1553 administered as part of a pilot vaccination strategy following licensure in Brazil.\n\nThe study will commence following the implementation of the pilot vaccination strategy in selected municipalities. Data for the analyses will be obtained from official Brazilian Ministry of Health surveillance systems, specifically the GAL (Laboratory Environment Management System), SINAN (Notifiable Diseases Information System), and Si-PNI (National Immunization Program Information System).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of the selected areas, within the age limits approved for the PVS, presenting at the health care facilities during the study period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have place of residence in a municipality where the pilot vaccination strategy is implemented;\n2. Are in an eligible age-group to receive the VLA1553 vaccine;\n3. Have been notified in SINAN as a suspected case for CHIK or Dengue surveillance during the study period;\n4. Have a sample registered in GAL that is collected within 0-5 days following the onset of CHIKV-like symptoms and is tested for CHIKV using RT-PCR;\n5. Have complete data in the Brazilian MoH databases (SINAN and GAL) on age, sex, municipality of residence, sample collection date, and date of symptom onset and the healthcare facilities where the suspected case was reported.\n\nExclusion Criteria:\n\n1. Have inconclusive RT-PCR result for CHIKV;\n2. Have the first CHIKV-like symptom onset less than 14 days from date of vaccination.'}, 'identificationModule': {'nctId': 'NCT07347002', 'briefTitle': 'Observational Study to Assess the Effectiveness of VLA1553 Vaccine in Preventing Chikungunya During a Pilot Vaccination Strategy in Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valneva Austria GmbH'}, 'officialTitle': 'A Test-Negative Case-control Study to Evaluate the Effectiveness of VLA1553 Against Chikungunya Virus Disease During a Pilot Vaccination Strategy in Brazil', 'orgStudyIdInfo': {'id': 'VLA1553-402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases: Test-positive for Chikungunya virus', 'interventionNames': ['Biological: Live-attenuated CHIKV vaccine VLA1553']}, {'label': 'Controls: Test-negative for Chikungunya virus', 'interventionNames': ['Biological: Live-attenuated CHIKV vaccine VLA1553']}], 'interventions': [{'name': 'Live-attenuated CHIKV vaccine VLA1553', 'type': 'BIOLOGICAL', 'description': 'Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is linked to this observational study.', 'armGroupLabels': ['Cases: Test-positive for Chikungunya virus', 'Controls: Test-negative for Chikungunya virus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60430-160', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Universidade Federal Do Ceará', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '31270-901', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '49060-025', 'city': 'Laranjeiras', 'state': 'Sergipe', 'country': 'Brazil', 'facility': 'Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus', 'geoPoint': {'lat': -10.80639, 'lon': -37.17}}, {'zip': '15090-000', 'city': 'São Pedro', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação Faculdade Regional De Medicina De São José Do Rio Preto', 'geoPoint': {'lat': -22.54861, 'lon': -47.91389}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valneva Austria GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Butantan Foundation', 'class': 'OTHER'}, {'name': 'Coalition for Epidemic Preparedness Innovations', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}