Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-02 @ 10:19 AM
Study NCT ID:
NCT04844632
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event Following Immunization - AEFI', 'timeFrame': '12 months from immunization', 'description': 'Adverse events (Adverse Event Following Immunization - AEFI) monitoring in vaccinated subjects and analyze associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.'}], 'secondaryOutcomes': [{'measure': 'Antibody response in vaccinated subject', 'timeFrame': '1, 3, 6, 12 months from immunization', 'description': 'To monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.'}, {'measure': 'Anti-Spike immune response', 'timeFrame': '1, 3, 6, 12 months from immunization', 'description': 'Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.'}, {'measure': 'Anti- Nucleoprotein (N) induced by natural infection evaluation', 'timeFrame': '1, 3, 6, 12 months from immunization', 'description': 'To assess the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;'}, {'measure': 'Neutralizing capacity of sera', 'timeFrame': '1, 3, 6, 12 months from immunization', 'description': 'to evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus'}, {'measure': 'Cell-mediated immune response', 'timeFrame': 'Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization', 'description': 'To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Vaccine'], 'conditions': ['Health Care Utilization', 'Health Care Associated Infection']}, 'referencesModule': {'references': [{'pmid': '36936925', 'type': 'DERIVED', 'citation': 'Capozzi A, Riitano G, Recalchi S, Manganelli V, Longo A, Falcou A, De Michele M, Garofalo T, Pulcinelli FM, Sorice M, Misasi R. Antiphospholipid antibodies in patients with stroke during COVID-19: A role in the signaling pathway leading to platelet activation. Front Immunol. 2023 Mar 2;14:1129201. doi: 10.3389/fimmu.2023.1129201. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n1\\. Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.\n\nSecondary objectives:\n\n1. Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.\n2. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.\n3. Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;\n4. Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus;\n5. To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.\n\nMethodology:\n\n1. Administration at baseline of a questionnaire for the collection of clinical data.\n2. Perform a blood sample to measure antibody response in vaccinated subjects\n3. Administer a questionnaire to evaluate adverse events after vaccination\n4. Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination\n5. An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.\n6. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.\n7. In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects (age\\> 18) booked for anti-SARS-CoV-2 vaccination at the AOU Policlinico Umberto I.\n\nSubjects will include healthcare personnel, medical students and university staff recruited from Sapienza University of Rome and Umberto I university hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.\n\nExclusion Criteria:\n\nAll subjects who refuse to give consent or who have contraindications to vaccination.'}, 'identificationModule': {'nctId': 'NCT04844632', 'acronym': 'SAPIENZAVAX', 'briefTitle': 'COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring', 'orgStudyIdInfo': {'id': 'COVID19 vaccination_Sapienza'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vaccine anti-Covid19', 'type': 'BIOLOGICAL', 'description': 'Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefania Basili, MD', 'role': 'CONTACT', 'email': 'stefania.basili@uniroma1.it'}], 'facility': 'AOU Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Stefania Basili, MD', 'role': 'CONTACT', 'email': 'stefania.basili@uniroma1.it', 'phone': '+393393452523'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Superiore di Sanità ', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Stefania Basili', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}