Covid19, Vaccine Reaction
Conditions
Brief summary
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.
Detailed description
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. All 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. At 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.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2 IgG II Quant
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
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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 * 18 years of age and older * Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria
* People who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 anti-RBD IgG concentration | Up to 1 week after examination | SARS-CoV-2 anti-RBD IgG antibody concentration was reported after analysing the specimen |
Countries
Vietnam
Contacts
Primary ContactLan TN Vuong, PhD
Outcome results
None listed