Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 3:06 PM
Study NCT ID:
NCT04709003
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'D012698', 'term': 'Serologic Tests'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1567}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 vaccine effectiveness (VE)', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers'}], 'secondaryOutcomes': [{'measure': 'Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers', 'timeFrame': '18 months', 'description': 'Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers'}, {'measure': 'asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers', 'timeFrame': '18 months', 'description': 'Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers'}, {'measure': 'Duration of effectiveness of the vaccine', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers over different periods of time'}, {'measure': 'Vaccine Effectiveness by age', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers of different age groups'}, {'measure': 'Vaccine Effectiveness by comorbidity', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers by various underly medical conditions'}, {'measure': 'Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in previously infection healthcare workers vaccinated with COVID-19 vaccine compared to previously infection unvaccinated healthcare workers'}, {'measure': 'VE by degree of exposure to COVID-19 patients', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers by degree of occupational exposure to COVID-019 patients'}, {'measure': 'VE by different SARS-CoV-2 variants', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers for different variant strains of SARS-CoV-2'}, {'measure': 'Vaccine effectiveness of one dose compared to two doses', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with two doses of COVID-19 vaccine compared to healthcare workers vaccinated with two doses of COVID-19 vaccine'}, {'measure': 'Compartive vaccine Effectiveness of different vaccine brands', 'timeFrame': '18 months', 'description': 'Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Corona Virus Infection', 'Vaccine Effectiveness']}, 'descriptionModule': {'briefSummary': 'Although clinical trials for approved COVID-19 vaccines demonstrated efficacy of the vaccine in preventing symptomatic infection, many questions about vaccine effectiveness, such as the effectiveness of COVID-19 vaccine in preventing asymptomatic infection, a surrogate for transmission, and duration of protection, can only be evaluated in real-world trials. The objective of the study is to evaluate COVID-19 vaccine effectiveness (Pfizer vaccine, and, if available, Moderna vaccine) in preventing infection in healthcare personnel in Israel. HCP who are Clalit members and working in Soroka, Beilinson, Meir, Haemek, Kaplan and Schneider hospitals, 18 years or older, and eligible to get COVID-19 vaccine according to Ministry of Health guidelines, will be recruited, regardless of their intention to get the COVID-19 vaccine. A baseline serology sample and respiratory sample will be collected. Participants will be asked to provide a respiratory sample weekly for 3 months, and then monthly for the remainder of the study. Participants will also have blood drawn at 1 month, 3 months, 6 months, 9 months and 12 months. Respiratory samples will be tested for SARS-CoV-2 by RT-PCR; serology will be tested for SARS-CoV-2 antibodies. The study will last for 12 months. For each participant, data will be extracted from the Electronic Medical Record for the period of the study and retrospectively from 2010.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthcare workers who work in 6 Clalit hospitals in Israel (Soroka, Kaplan, Meir, Beilinson, HaEmek, and Schneider)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Any HCP at any of the participating hospitals who is\n\n* a member of Clalit Health Services\n* is eligible to get the Covid-19 vaccine\n* did not receive the first dose of COVID-19 vaccine more than 21 days prior to the enrollment date\n\nExclusion Criteria:\n\n\\-\n\nEmployees at any of the participating hospitals will be excluded if they are:\n\n* not a member of Clalit Health Services; or\n* not eligible to get the Covid-19 vaccine according to the Ministry of Health guidelines; or\n* Less than 18 years of age\n* Received first dose of COVID-19 vaccine more than 21 days prior to date of enrollment'}, 'identificationModule': {'nctId': 'NCT04709003', 'acronym': 'CoVEHPI', 'briefTitle': 'Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '1051-20-RMC-C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vaccinated', 'description': 'participants who received the Covid-19 vaccine', 'interventionNames': ['Diagnostic Test: Serologic test', 'Diagnostic Test: Respiratory swabs']}, {'label': 'unvaccinated', 'description': "participants who didn't received the Covid-19 vaccine", 'interventionNames': ['Diagnostic Test: Serologic test', 'Diagnostic Test: Respiratory swabs']}], 'interventions': [{'name': 'Serologic test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A blood test to check antibodies type and amount', 'armGroupLabels': ['unvaccinated', 'vaccinated']}, {'name': 'Respiratory swabs', 'type': 'DIAGNOSTIC_TEST', 'description': 'PCR test to Covid-19', 'armGroupLabels': ['unvaccinated', 'vaccinated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Beilinson hospital', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Innovation Officer, Clalit Health Services', 'investigatorFullName': 'Ran Balicer', 'investigatorAffiliation': 'Clalit Health Services'}}}}