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.
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
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.
- Conditions
- Covid19, Vaccine Reaction
- 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.
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.
- First posted27 Sep 2021
- Study start25 Sep 2021
- Primary completion30 Sep 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, MD, Principal investigator, HOPE Research Center, My Duc Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SARS-CoV-2 RBD Antibody in Vaccinated Healthcare Workers at My Duc Hospital: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05057910
- Acronym / sponsor ID
- 10/21/ĐĐ-BVMĐ
- Conditions
- Covid19, Vaccine Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers of My Duc hospital who were vaccinated with at least one dose of ChAdOx1 nCoV-19.
Key inclusion criteria (3 listed)
- Above 18 years old
- Being vaccinated with at least one dose of ChAdOx1 nCoV-19
- Accepted to take part in the study
Key exclusion criteria (1 listed)
- Currently being diagnosed with Covid-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 IgG II Quant3ml 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 | Diagnostic test | – |
Primary outcome
SARS-CoV-2 anti-RBD IgG concentration
Time frame: Up to 1 week after examination
SARS-CoV-2 anti-RBD IgG antibody concentration was reported after analysing the specimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, MD principal investigator
HOPE Research Center, My Duc Hospital
1 site in 1 country: see every site and its status.
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.