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

• Conditions: Covid19; Vaccine Reaction

• Registration Number: NCT05094635
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-11-01
• Study Start: 2021-11-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 772

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Medicine and Pharmacy; 🇻🇳 Ho Chi Minh City, Vietnam