Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

772 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Vaccine Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SARS-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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lan Ngoc Vuong

Head of Department of Obstetrics and Gynaecology; Dean, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tuan D Tran, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Medicine and Pharmacy

Ho Chi Minh City, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lan TN Vuong, PhD

Role: CONTACT

Phone: +84901183918

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

473/HDDD-DHYD

Identifier Type: -

Identifier Source: org_study_id