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Covid19NCT05057910

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

An observational study of Covid19 and Vaccine Reaction, run by Mỹ Đức Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, Vaccine Reaction
What is being tested?
SARS-CoV-2 IgG II Quant
How many people
645 participants
Where
1 siteVietnam
Study dates
25 Sep 2021to 7 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Currently being diagnosed with Covid-19

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • HOPE Research Center, My Duc Hospital

    Ho Chi Minh City, Tan Binh

Other trials in Vietnam

About this study

Official title: Evaluation of SARS-CoV-2 RBD Antibody in Vaccinated Healthcare Workers at My Duc Hospital: a Cross-sectional Study

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.

Read the detailed description

Severe acute respiratory syndrome caused by coronavirus 2 (SARS-CoV-2) emerged in December 2019 from Wuhan, China. This pandemic quickly spread to many countries and became a global health challenge with profound impacts on human health as well as on economic and social life. As of September 12, 2021, according to the statistic registry of the Ministry of Health of Vietnam, the total number of SARS-CoV-2 infections is 624,547 cases, of which the number of deaths is up to 15,660 cases.

Besides social distancing, masking, and handwashing, vaccine is one of the most efficient ways to prevent COVID-19. Most of the vaccines currently available only provide one precursor or vector of protein S, the anti-nucleocapsid (anti-N) antibodies are not fully developed and only anti-S antibodies could be detected (which target spike protein sub-domains, S1 and RBD). On the other hand, due to the biological role of nucleocapsid and the fact that it is protected from antibodies by viral or cellular membranes, nucleocapsid protein (NP) antibodies are unlikely to directly neutralize SARS-CoV-2. For the above-mentioned reasons, screening for anti-S or anti-RBD antibodies is commonly used to investigate the presence of humoral immune markers following a Covid infection or after vaccination.

In the event of vaccination, the duration of antibody persistence is yet unknown. Large cohort studies showed that 90-99% of individuals infected with the SARS-CoV-2 virus developed detectable neutralizing antibodies within 2-4 weeks following infection and immune responses remain robust and protective against reinfection for at least 6-8 months later. In Vietnam, studies on antibody levels after exposure to SARS-CoV-2 or after vaccination are receiving more and more attention. Mai et al. conducted a study to assess the kinetics of antibody titers of eleven COVID-19 infected individuals and found out that the titers of RBD-targeting NAbs decayed by 18-30 weeks after the infection. Chau et al (2021) investigated the vaccine-induced production of neutralizing antibodies after injecting ChAdOx1 nCoV-19 AZD1222 vaccine (Oxford-AstraZeneca) on 554 Vietnamese healthcare workers. This study demonstrated that the concentration of neutralizing antibodies increased after each dose. However, three months after the first dose, neutralizing antibody levels reduced significantly, while the seroconversion rate slightly declined from 98.1% to 94.7% at day 14 after the second dose, but this study did not report neutralizing antibody levels.

Some studies indicated that the efficacy of the Covid-19 vaccine might decrease over time, as demonstrated by the decline of blood antibodies level, thus suggest providing additional booster dose in the hope of increasing protection. However, more information about antibody titers after vaccination is still needed, especially for the Vietnamese population. Therefore, This study is conducted to evaluate the immune response created by the ChAdOx1 nCoV-19 vaccination by measuring the titers of antibodies against the SARS-CoV-2 spike protein receptor binding domain (RBD) among healthcare workers of My Duc Hospital and to investigate potential associations of vaccine protection and infection in this population.

Being tested
SARS-CoV-2 IgG II Quant
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 IgG II QuantDiagnostic 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARS-CoV-2 anti-RBD IgG concentration

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

    Measured: Up to 1 week after examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start25 Sep 2021
  3. Primary completion30 Sep 2021
  4. Study completion7 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
645 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057910
Sponsor's protocol ID
10/21/ĐĐ-BVMĐ
Status last verified
Aug 2022
First submitted
20 Sep 2021
Last updated
23 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Vaccine Reaction, run by Mỹ Đức Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 anti-RBD IgG concentration (time frame: Up to 1 week after examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.

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