Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06162533
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Severe Acute Respiratory Syndrome Coronavirus 2 Re-Infection Risk and Vaccine Efficacy in Austria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9090868}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 death', 'timeFrame': 'January 1, 2000 to June 30, 2023', 'description': 'Death due to COVID-19'}], 'secondaryOutcomes': [{'measure': 'SARS-CoV-2 infection', 'timeFrame': 'January 1, 2000 to June 30, 2023', 'description': 'Documented SARS-CoV-2 infection'}, {'measure': 'ICU stay', 'timeFrame': 'January 1, 2000 to June 30, 2023', 'description': 'ICU stay of COVID-19 patients'}, {'measure': 'Hospitalization', 'timeFrame': 'January 1, 2000 to June 30, 2023', 'description': 'Hospitalization of COVID-19 patients'}, {'measure': 'All-cause mortality', 'timeFrame': 'January 1, 2000 to June 30, 2023', 'description': 'Death due to all-causes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The coronavirus disease 2019 (COVID-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. In this study, we aim to evaluate how strong and how long are individuals in Austria after vaccination and/or infection with SARS-CoV-2 protected against COVID-19 disease.\n\nIn this project, we will analyze national health data from all inhabitants of Austria (about 9 million persons) during the COVID-19 pandemic. The population of Austria will be stratified into different groups according to previous vaccinations against SARS-CoV-2 and previous SARS-CoV-2 infections.\n\nWe primarily evaluate how strong and how long after vaccination against SARS-CoV-2 and/or infection with SARS-CoV-2, the risk for COVID-19 deaths is reduced or altered as compared to less vaccinated and/or infected persons. As secondary study aims, we perform such analyses also for SARS-CoV-2 infections, hospitalizations and intensive care unit (ICU) stays, with or due to SARS-CoV-2. These analyses will be performed during different time periods of the COVID-19 pandemic, and we will also perform various subgroup analyses as for example according to age and gender. Given that antibodies against SARS-CoV-2 are usually detected after vaccination and/or infection, we will use such antibody data from blood donors in Tyrol, to elucidate how well the national health data on SARS-CoV-2 infections and vaccinations match with the respective antibody data, and how well these antibody data indicate risk of COVID-19 deaths and infections.\n\nWe will calculate the probability of dying due to a SARS-CoV-2 infection (case/infection fatality rate) for different times of the COVID-19 pandemic, in order to document the health threat due to SARS-CoV-2. Based on all these data, we will calculate how many persons have to be vaccinated against SARS-CoV-2 to prevent one COVID-19 death at different times during this COVID-19 pandemic. We will consider the respective COVID-19 policies such as mask mandates, lock-downs, SARS-CoV-2 test mandates in our analyses and will evaluate the impact of these policies on COVID-19 deaths and diseases. In addition, we will evaluate data on total mortality according to the number of SARS-CoV-2 vaccinations and/or infections, and we will aim to collaborate with other research groups in order to extend our analyses.\n\nIn conclusion, the results of this study should provide an overview on the COVID-19 pandemic with respect to protection conferred by vaccinations and previous SARS-CoV-2 infections, as well as the health threat of SARS-CoV-2, in order to provide knowledge for future COVID-19 policy and future pandemics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The national population of Austria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Residency in Austria.\n\nExclusion Criteria:\n\n\\- None.'}, 'identificationModule': {'nctId': 'NCT06162533', 'acronym': 'SARIVA', 'briefTitle': 'Severe Acute Respiratory Syndrome Coronavirus 2 Re-Infection Risk and Vaccine Efficacy in Austria', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'SARS-CoV-2 Re-Infection Risk and Vaccine Efficacy in Austria: SARIVA Study', 'orgStudyIdInfo': {'id': 'SARIVA 1.0.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinated against SARS-CoV-2', 'description': 'Individuals who received a SARS-CoV-2 vaccine but have no record of a previous SARS-CoV-2 infection.\n\nSubgroups will be formed according to the number and type of vaccines against SARS-CoV-2.', 'interventionNames': ['Biological: Vaccination against SARS-CoV-2']}, {'label': 'Previously SARS-CoV-2 infected', 'description': 'Individuals who were previously infected with SARS-CoV-2 but have not received a SARS-CoV-2 vaccine.\n\nSubgroups will be formed according to the number and time period of previous SARS-CoV-2 infections.'}, {'label': 'Hybrid Immunity against SARS-CoV-2', 'description': 'Individuals who received a SARS-CoV-2 vaccine and who were previously infected with SARS-CoV-2.\n\nSubgroups will be formed according to the number and time period of previous SARS-CoV-2 infections, the number and type of vaccines against SARS-CoV-2, and according to whether the vaccination or the infection was the first immune conferring event.', 'interventionNames': ['Biological: Vaccination against SARS-CoV-2']}, {'label': 'No immunity against SARS-CoV-2', 'description': 'Individuals who have not received a SARS-CoV-2 vaccine and were not previously infected with SARS-CoV-2.'}], 'interventions': [{'name': 'Vaccination against SARS-CoV-2', 'type': 'BIOLOGICAL', 'otherNames': ['Infection with SARS-CoV-2'], 'description': 'Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2', 'armGroupLabels': ['Hybrid Immunity against SARS-CoV-2', 'Vaccinated against SARS-CoV-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Austrian Agency for Health and Food Safety', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The individual participant data of this study are available upon request with approval needed from the Austrian Agency for Health and Food Safety (AGES), Vienna, Austria, and an ethical approval or waiver by the local ethic committee for use of these data. The individual participant data are not publicly available due to restrictions pertaining to contained information that could compromise the privacy of individuals (i.e. potentially allow the identification of certain individuals based on e.g. birthdate, gender and infection or death date). Data are stored at the AGES. The same data availability rules apply to the antibody data (i.e. Anti-SARS-CoV-2 antibodies) from the Medical University of Innsbruck.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'AGES', 'class': 'UNKNOWN'}, {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': 'Austrian Science Fund (FWF)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}