Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 8:56 AM
Study NCT ID:
NCT05104359
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2021-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Quantitative Antibody Titers & Booster Vaccinations
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': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-29', 'size': 612240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-01T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccine Response', 'timeFrame': '>21 days', 'description': 'Levels of Roche SARS-CoV-2 Semi-Quant Spike Ig antibody'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Observational', 'Vaccination', 'Antibody', 'Booster'], 'conditions': ['COVID-19', 'COVID-19 Vaccines', 'Immunogenicity, Vaccine']}, 'descriptionModule': {'briefSummary': 'This is an observational study aiming at describing COVID-19 vaccination outcomes among HIV-positive and HIV-negative individuals, using electronic health records to observe their usual clinical care. This study will describe levels of COVID-19 vaccine response (i.e., Ig spike antibody measurements). Rates of antibody level decay after vaccination will be assessed. The efficacy of using antibody levels to help guide the timing of booster doses among HIV-negative and HIV-positive patients will be evaluated.', 'detailedDescription': 'The aim of this study is to assess levels of COVID-19 vaccine response through measuring surrogate Ig spike antibody measurements, to determine the rates of antibody level decay after vaccination, and to measure the efficacy of utilizing these antibody measurements to help guide the timing of booster doses among HIV-negative and HIV-positive patients.\n\nThe study population will include adults who were fully vaccinated against SARS-CoV-2 virus (i.e., two doses of Pfizer or Moderna vaccines or one dose of the J\\&J vaccine), and have received a Roche SARS-CoV-2 Semi-Quant Spike Ig Ab test at least 3 weeks after full vaccination as part of their usual clinical care at AHF Midtown Manhattan Healthcare Center.\n\nIncidence rates of COVID vaccine response levels (i.e., adequate, low, non-response) will be estimated using univariate Poisson regression, overall and by vaccine type. Among individuals with at least two antibody measurements, rates of antibody levels decay will be estimated using univariate linear regression, overall and stratified by HIV status, vaccine type and baseline CD4 cell count. In the sub-population of individuals who received a COVID vaccine booster, vaccination and antibody response will be characterized at least 3 weeks after the booster is received. Univariate linear regression will be used to estimate rates of antibody levels decay, among individuals with at least two antibody measurements, including one after the booster dose. Rates of response decay will be produced overall, and stratified by HIV status, booster type and baseline CD4 cell count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals presenting for care at AHF Midtown Manhattan Healthcare Center who received COVID-19 vaccination and antibody testing; followed through their electronic health records in the OPERA Observational Database.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cared for at AHF Midtown Manhattan Healthcare Center and followed in the OPERA observational database\n* Active in care in the last 24 months\n* Fully vaccinated against SARS-CoV-2 virus, implemented as 21 days after the second Pfizer or Moderna injections, 21 days after the one J\\&J injection\n* Received a Roche SARS-CoV-2 Semi-Quant Spike Ig AB test after full vaccination as usual clinical care\n\nExclusion Criteria:\n\n* Unvaccinated or partially vaccinated against SARS-CoV-2 virus\n* Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination'}, 'identificationModule': {'nctId': 'NCT05104359', 'briefTitle': 'COVID-19 Quantitative Antibody Titers & Booster Vaccinations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epividian'}, 'officialTitle': 'Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age?', 'orgStudyIdInfo': {'id': 'COL2021-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'HIV-positive versus HIV-negative patients, individuals with at least 2 measurements of antibody levels, and boosted individuals are the subgroups of interest.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'AHD Manhattan Midtown HCC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ricky Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHF Midtown Manhattan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epividian', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AIDS Healthcare Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}