SARS-CoV-2 (Covid-19) RBD Antibody in My Duc Hospital Healthcare Workers

NCT05057910 | Completed

• 1 other identifier: 10/21/ĐĐ-BVMĐ
• Study Type: observational
• Target: 645
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the immune response to the ChAdOx1 nCoV-19 vaccine by measuring the titers of antibody against the SARS-CoV-2 spike protein receptor binding domain (RBD) among healthcare workers of My Duc Hospital and investigate potential associations of vaccine protection against infection in this population. The study's data can suggest the groundwork for the development of predictive models for post-vaccination protection in the Vietnamese population as well as for establishing vaccination strategies to control disease outbreaks in the future.

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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare workers of My Duc hospital who were vaccinated with at least one dose of ChAdOx1 nCoV-19.

You may qualify if:

• Above 18 years old
• Being vaccinated with at least one dose of ChAdOx1 nCoV-19
• Accepted to take part in the study

You may not qualify if:

• Currently being diagnosed with Covid-19

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

HOPE Research Center, My Duc Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

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

• Tuong M Ho, MD

  HOPE Research Center, My Duc Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 27, 2021
• Study Start: September 25, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 7, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)