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

NCT05094635 | Unknown

• 1 other identifier: 473/HDDD-DHYD
• Study Type: observational
• Target: 772
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 anti-RBD IgG concentration

  SARS-CoV-2 anti-RBD IgG antibody concentration was reported after analysing the specimen

  Up to 1 week after examination

Interventions

SARS-CoV-2 IgG II Quant DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• years of age and older
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

• People who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medicine and Pharmacy

Ho Chi Minh City, 700000, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and DNA samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tuan D Tran, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan TN Vuong, PhD

CONTACT

+84901183918; lanvuong@ump.edu.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Obstetrics and Gynaecology; Dean, Faculty of Medicine

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: October 26, 2021
• Study Start: November 30, 2021
• Primary Completion: December 31, 2021
• Study Completion: May 1, 2022
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)