Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT04862806
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2021-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087124', 'term': 'COVID-19 Serological Testing'}], 'ancestors': [{'id': 'D000086742', 'term': 'COVID-19 Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012698', 'term': 'Serologic Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All enrolled CLL patients have received 2 shots of BNT162b2 mRNA vaccine, and the investigators will check the efficacy and safety of this vaccine in the enrolled population- the intervention is the diagnostic test of COVID-19 serology'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-11', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.", 'timeFrame': '2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination', 'description': 'Answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire on the same clinic visit when blood is drawn for serologic tests.'}, {'measure': 'Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia', 'timeFrame': '6 months', 'description': 'To study the efficacy of booster vaccine in patients with CLL who are seronegative after first 2 vaccines'}], 'secondaryOutcomes': [{'measure': 'Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.', 'timeFrame': '2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination', 'description': 'A centralized assessment of the serological response for 4 medical centers is performed on serum samples stored at -60 °C using Abbott-SARS-CoV-2 IgG quant (Positive value \\> 151; range 0-40.000). The other 4 medical centers performed the test locally using DiaSorins-LAISISON SARS-CoV S1/S2 IgG test (positive value \\>15 range 15-400). In the central virus laboratory at the Chaim Sheba Medical center the test was done by Elisa-RDB (positive value \\>1.1; range 1.1-10).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLL', 'BNT162b2 mRNA Covid-19 Vaccine'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '34861036', 'type': 'DERIVED', 'citation': 'Herishanu Y, Rahav G, Levi S, Braester A, Itchaki G, Bairey O, Dally N, Shvidel L, Ziv-Baran T, Polliack A, Tadmor T, Benjamini O; Israeli CLL Study Group. Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination. Blood. 2022 Feb 3;139(5):678-685. doi: 10.1182/blood.2021014085.'}]}, 'descriptionModule': {'briefSummary': 'On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CLL was according to the IWCLL criteria\n* All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).\n\nExclusion Criteria:\n\n* previous covid19 virus infection'}, 'identificationModule': {'nctId': 'NCT04862806', 'briefTitle': 'Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA', 'orgStudyIdInfo': {'id': '0214-20-BNZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Israel CLL study group', 'description': 'BNT162b2 mRNA vaccine', 'interventionNames': ['Diagnostic Test: COVID-19 serology']}], 'interventions': [{'name': 'COVID-19 serology', 'type': 'DIAGNOSTIC_TEST', 'description': 'Immune response to BNT162b2 mRNA vaccine is assessed on the basis of anti covid19 IgG levels. A centralized assessment of the serological response for 4 medical centers is performed on serum samples stored at -60 °C using Abbott-SARS-CoV-2 IgG quant (Positive value \\> 151; range 0-40.000). The other 4 medical centers performed the test locally using DiaSorins-LAISISON SARS-CoV S1/S2 IgG test (positive value \\>15 range 15-400). In the central virus laboratory at the Chaim Sheba Medical center the test was done by Elisa-RDB (positive value \\>1.1; range 1.1-10).', 'armGroupLabels': ['Israel CLL study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31048', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Tamar Tadmor, MD', 'role': 'CONTACT', 'email': 'tamar.tadmor@b-zion.org.il', 'phone': '+97248359', 'phoneExt': '407'}], 'facility': 'Bnai Zion Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ohad Benjamini', 'role': 'CONTACT', 'email': 'ohadb.mail@gmail.com', 'phone': '00972526669155'}], 'facility': 'Hematology Division, Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ziv Medical Center', 'class': 'OTHER'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}, {'name': 'Galilee Medical Center', 'class': 'UNKNOWN'}, {'name': 'Kaplan Medical Center', 'class': 'OTHER'}, {'name': 'Meir Medical Center', 'class': 'OTHER'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Rabin Medical Center', 'class': 'OTHER'}, {'name': 'Sourasky Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'HEAD OF HEMATOLOGY', 'investigatorFullName': 'tamar.tadmor', 'investigatorAffiliation': 'Bnai Zion Medical Center'}}}}