Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 4:41 AM
Study NCT ID:
NCT04920357
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response to Vaccination Against Covid-19, a Follow up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Periferal blood mononuclear cells (PBMC), plasma and sera.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time.', 'timeFrame': '1 and 6 months, 1, 2, 3, and 4 years after vaccination.', 'description': 'Levels of specific IgG antibody against SARS-CoV-2 will be measured as optical density, OD in a specific Spike-protein IgG ELISA at each time-point.'}, {'measure': 'Change in proportion of participants with detectable specific IgG antibodies after vaccination over time.', 'timeFrame': '1 and 6 months, 1, 2, 3, and 4 years after vaccination', 'description': 'Immune response will be measured as the proportion of participants (in % of all vaccinated individuals) with detectable specific IgG antibodies after vaccination at each time-point (in months after vaccination).'}], 'secondaryOutcomes': [{'measure': 'Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals.', 'timeFrame': 'Change of markers for cellular and serological immune response over time measured at 1 and 6 months, 1, 2, 3, and 4 years after vaccination', 'description': 'Levels of markers for cellular and serological immune response after COVID-19 vaccination e.g. specific antibodies, T- and B-cell memory.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune response', 'Immunoglobulin G'], 'conditions': ['Vaccination; Infection', 'Covid19']}, 'descriptionModule': {'briefSummary': 'The study investigates the immune response after vaccination in individuals with and without pre-existing immunity to Coronavirus disease (COVID) -19. The participants are followed and sampled up to 4 years after vaccination. Blood samples are collected at different timepoints to analyze immune response.\n\nThe aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.', 'detailedDescription': 'The main objective is to investigate if the antibody development to SARS-CoV-2 S protein differ after vaccination in those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals.\n\nThe secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups.\n\nIndividuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign.\n\nThe study includes all approved COVID-19 vaccines with marketing authorization in Sweden.\n\nPersons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response.\n\nData on sex, age, body mass index, medical history and concomitant medication is collected.\n\nThe study is a follow-up study after vaccination and approved by the Swedish Medical Products Agency (EudraCT 2021-000683-30). Regular monitoring of the study is performed by the Clinical Trial unit at Umeå University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with and without pre-existing immunity to Covid-19 that are vaccinated in the national and regional vaccine campaign.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consents to participate in the study\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Incapable of giving informed consent\n* Contraindication to vaccination\n* Severe disease\n* Ongoing treatment that is judged to affect the vaccine response (Does not include Rituximab which is allowed after individual consideration). Steroids \\> 15 mg orally per day.'}, 'identificationModule': {'nctId': 'NCT04920357', 'acronym': 'CoVacc', 'briefTitle': 'Immune Response to Vaccination Against Covid-19, a Follow up Study', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study', 'orgStudyIdInfo': {'id': 'Eudra-CT2021-000683-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-COVID-19', 'description': 'Persons with a verified previous COVID-19 infection', 'interventionNames': ['Drug: Vaccination']}, {'label': 'COVID-19 naive', 'description': 'Persons that have no history of COVID-19', 'interventionNames': ['Drug: Vaccination']}], 'interventions': [{'name': 'Vaccination', 'type': 'DRUG', 'description': 'Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.', 'armGroupLabels': ['COVID-19 naive', 'Post-COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '633 49', 'city': 'Eskilstuna', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Markus Kalén, MD', 'role': 'CONTACT', 'email': 'markus.kalen@regionsormland.se', 'phone': '+46 (0)16-10 30 00'}], 'facility': 'Mälarsjukhuset', 'geoPoint': {'lat': 59.36661, 'lon': 16.5077}}, {'zip': '651 85', 'city': 'Karlstad', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Staffan Tevell, PhD', 'role': 'CONTACT', 'email': 'staffan.tevel@regionvarmland.se', 'phone': '+46 (0) 10-8315000'}], 'facility': 'Karlstad Central hospital', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'zip': '701 85', 'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anja Rosdahl, MD', 'role': 'CONTACT', 'email': 'anja.rosdahl@regionorebrolan.se', 'phone': '+46- (0)19-602 10 00'}], 'facility': 'Örebro University hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '831 83', 'city': 'Östersund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Micael Widerström, Assoc Prof', 'role': 'CONTACT', 'email': 'micael.widerstrom@umu.se', 'phone': '+46 (0)63-15 30 00'}], 'facility': 'Östersund hospital', 'geoPoint': {'lat': 63.1792, 'lon': 14.63566}}, {'zip': '901 85', 'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johan Normark, Assoc Prof', 'role': 'CONTACT', 'email': 'johan.normark@umu.se', 'phone': '+46- (0) 70-2258959'}], 'facility': 'Umeå University hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Clas Ahlm, Prof', 'role': 'CONTACT', 'email': 'clas.ahlm@umu.se', 'phone': '+46-(0)70-3172965'}, {'name': 'Mattias Forsell, Assoc Prof', 'role': 'CONTACT', 'email': 'mattias.forsell@umu.se', 'phone': '+46-(0)73-0211221'}], 'overallOfficials': [{'name': 'Clas Ahlm, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Västerbotten', 'class': 'OTHER_GOV'}, {'name': 'Värmland County Council, Sweden', 'class': 'OTHER_GOV'}, {'name': 'Örebro Läns Landsting', 'class': 'OTHER_GOV'}, {'name': 'Sormland County Council, Sweden', 'class': 'OTHER'}, {'name': 'Region Jämtland Härjedalen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}