Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04842305
Status:
UNKNOWN
Last Update Posted:
2021-04-13
First Post:
2021-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma', 'timeFrame': 'Between 21 and 200 days after infection/vaccination', 'description': 'Detection of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma in participants who have been infected with COVID-19, vaccinated with Pfizer-BioNTech/Moderna mRNA-1273/AstraZeneca or infected and vaccinated'}], 'secondaryOutcomes': [{'measure': 'Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma', 'timeFrame': 'Between 21 and 200 days after vaccination', 'description': 'Comparison of SARS-CoV-2 spike glycoprotein RBD antibodies (in saliva and plasma) between participants vaccinated with Pfizer-BioNTech, Moderna mRNA-1273 and AstraZeneca'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sars-cov-2 antibodies', 'saliva', 'mucosal immunity', 'vaccination', 'covid19', 'spike glycoprotein'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who belong to one of the following four groups will be included G1=SARS-COV-2 Naïve (=Not SARS-CoV-2 vaccinated and COVID-19 negative), G2=COVID-19 convalescents, G3=Vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine, G4=COVID-19 positive and vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Both Hospital staff as well as non-health care workers will be invited to participate\n\nExclusion Criteria:\n\n* Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.\n* Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.'}, 'identificationModule': {'nctId': 'NCT04842305', 'briefTitle': 'Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bispebjerg and Frederiksberg'}, 'officialTitle': 'Induction of SARS-CoV-2 Spike Glycoprotein Antibodies in Saliva and Plasma in Response to a COVID-19 Infection, Systemic COVID-19 Vaccination, and the Combination of COVID-19 and Vaccination', 'orgStudyIdInfo': {'id': 'P-2021-224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'G1: Control group', 'description': 'SARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls)', 'interventionNames': ['Diagnostic Test: Blood- and saliva tests']}, {'label': 'G2: COVID-19 infected', 'description': 'Persons who have had COVID-19', 'interventionNames': ['Diagnostic Test: Blood- and saliva tests']}, {'label': 'G3: COVID-19 vaccinated', 'description': 'Persons who have been vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S', 'interventionNames': ['Diagnostic Test: Blood- and saliva tests']}, {'label': 'G4: COVID-19 infected and vaccinated', 'description': 'Individuals who have been infected with COVID-19 and subsequently been vaccinated', 'interventionNames': ['Diagnostic Test: Blood- and saliva tests']}], 'interventions': [{'name': 'Blood- and saliva tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva', 'armGroupLabels': ['G1: Control group', 'G2: COVID-19 infected', 'G3: COVID-19 vaccinated', 'G4: COVID-19 infected and vaccinated']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lennart Friis-Hansen, Dr.med.', 'role': 'CONTACT', 'email': 'lennart.jan.friis-hansen@regionh.dk', 'phone': '61145916'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lenanrt Friis-Hansen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of Clinical Biochemistry MD, DMSc, Principal Investigator', 'investigatorFullName': 'Lenanrt Friis-Hansen', 'investigatorAffiliation': 'University Hospital Bispebjerg and Frederiksberg'}}}}