Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04775056
Status:
WITHDRAWN
Last Update Posted:
2022-08-03
First Post:
2021-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Vaccines Against COVID-19 in the Real World
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity index-seroconversion rates of neutralizing antibody', 'timeFrame': 'The 4 weeks after the second dose vaccination', 'description': 'Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.'}], 'secondaryOutcomes': [{'measure': 'Safety index-incidence of adverse reactions', 'timeFrame': 'Day 0-28 after each dose vaccination', 'description': 'Incidence of adverse reactions after each dose vaccination'}, {'measure': 'Immunogenicity index-seropositive rates of neutralizing antibody', 'timeFrame': 'The 4, 12, 24, and 48 weeks after the second dose vaccination', 'description': 'neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Liver Disease', 'Hepatic Carcinoma']}, 'descriptionModule': {'briefSummary': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have afflicted tens of millions of people in a worldwide pandemic. Considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. Recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including DNA- and mRNA-based vaccines are beginning in many parts of the world. Randomized clinical trials of different vaccines reported efficacies for preventing COVID-19 in the range of 50% to 95%.\n\nAlthough these randomized clinical trials are considered the "gold standard" for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout.\n\nThe aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against COVID-19 under real-world practice conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who received COVID-19 vaccines under real-life practice conditions in the World', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects received COVID-19 vaccines;\n* Able to comprehend and provide written informed consent in accordance with institutional guidelines.\n\nExclusion Criteria:\n\n* Not received any COVID-19 vaccines;\n* Not willing to participate and/or give their written informed consent.'}, 'identificationModule': {'nctId': 'NCT04775056', 'briefTitle': 'A Study to Evaluate Vaccines Against COVID-19 in the Real World', 'organization': {'class': 'OTHER', 'fullName': 'Humanity & Health Medical Group Limited'}, 'officialTitle': 'A Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of Vaccines Against COVID-19 in the Real World', 'orgStudyIdInfo': {'id': 'APASL_COVID-19 Vaccine_Ab'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Humanity & Health Medical Group', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'George Lau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanity & Health Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanity & Health Medical Group Limited', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}