Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05094635
Status:
UNKNOWN
Last Update Posted:
2021-11-01
First Post:
2021-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum and DNA samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 772}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 anti-RBD IgG concentration', 'timeFrame': 'Up to 1 week after examination', 'description': 'SARS-CoV-2 anti-RBD IgG antibody concentration was reported after analysing the specimen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Vaccine Reaction']}, 'descriptionModule': {'briefSummary': 'This study will investigate the presence of SARS-CoV-2 neutralizing antibody and its association with demographic information, medical history of SARS-CoV-2 infected individuals, exposure history of close contacts, vaccination status, and compliance with the strategies for self-quarantine to prevent the transmission in the community where SARS-CoV-2 infected individuals were home-quarantined and treated.', 'detailedDescription': 'In the 4th outbreak of the covid-19 pandemic in Ho Chi Minh City since 27 April 2021, asymptomatic or mild covid-19 patients were self-quarantined and treated at home. This home care setting could yield risk of SARS-CoV-2 transmission from the index cases to the people living surroundings. Therefore, this study will be performed to investigate the immunogenicity against SARS-CoV-2 in household members or people lived in the same municipality with home-quarantined covid-19 patients.\n\nAll people over 18 years old, living in 2 blocks (V and Y) of Ngo Gia Tu apartment, which is located in District 10, Ho Chi Minh City, will be recruited into this study. A survey will be conducted using a questionnaire to collect the data related to the basic demographic information, medical history of SARS-CoV-2 infected individuals, exposure history of close contacts, vaccination status, and compliance with the strategies for self-quarantine to prevent the transmission in the community.\n\nAt the time of recruitment, Covid-19 rapid antigen detection tests using nasopharyngeal swabs will be performed for all study subjects. In addition, a total of 5mL of intravenous blood samples will be collected for serum extraction and DNA isolation. SARS-CoV-2 neutralizing antibody levels in serum samples will be evaluated by a surrogate virus neutralization test by using NeutraLISA kit® (Euroimmun, Luebeck, Germany). DNA will be isolated and stored for further use in investigating the association of ACE2 genetic polymorphisms with the prevalence of SARS-CoV-2 neutralizing antibodies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People 18 years of age and older, who lived in 2 blocks (V and Y) of Ngo Gia Tu apartment, located in District 10, Ho Chi Minh City, Vietnam, from July to September 2021', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People who lived in the two blocks (V and Y) of Ngo Gia Tu apartment, located in District 10, Ho Chi Minh City, Vietnam, from July to September 2021\n* 18 years of age and older\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* People who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)'}, 'identificationModule': {'nctId': 'NCT05094635', 'briefTitle': 'Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts', 'organization': {'class': 'OTHER', 'fullName': 'University of Medicine and Pharmacy at Ho Chi Minh City'}, 'officialTitle': 'Characteristics of Immunogenicity Against SARS-CoV-2 in the Community With Home-quarantined Covid-19 Patients in Ho Chi Minh City, Vietnam', 'orgStudyIdInfo': {'id': '473/HDDD-DHYD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SARS-CoV-2 IgG II Quant', 'type': 'DIAGNOSTIC_TEST', 'description': '3ml of blood samples are collected, contained in heparin-free tubes, and centrifuged. Blood serum samples are collected and stored at the -80 Celcius degree. SARS-CoV-2 IgG antibodies in human serum and plasma are detected using chemiluminescent microparticle immunoassay (CMIA) technology on the ARCHITECT I 1000r System. Quality Control procedures will take place once daily, with three levels: one negative control and two positive controls. Sample, SARS-CoV-2 antigen-coated paramagnetic microparticles, and assay diluent are combined and incubated. The SARS-CoV-2 IgG antibodies present in the sample bind to the antigen-coated microparticles. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the titres of IgG antibodies to SARS-CoV-2 in the sample and the RLU detected by the system optics. Interpretation of Results: \\< 50.0 AU/mL, Negative, ≥ 50.0 AU/mL, Positive'}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University of Medicine and Pharmacy', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Lan TN Vuong, PhD', 'role': 'CONTACT', 'email': 'lanvuong@ump.edu.vn', 'phone': '+84901183918'}], 'overallOfficials': [{'name': 'Tuan D Tran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Obstetrics and Gynaecology; Dean, Faculty of Medicine', 'investigatorFullName': 'Lan Ngoc Vuong', 'investigatorAffiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}}}}