Covid19NCT05094635
Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts
An observational study of Covid19 and Vaccine Reaction, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… 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
- 772 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Nov 2021to 1 May 2022
- 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
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- People who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Immunogenicity Against SARS-CoV-2 in the Community With Home-quarantined Covid-19 Patients in Ho Chi Minh City, Vietnam
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.
Read the 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.
- 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 posted26 Oct 2021
- Study start30 Nov 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 May 2022 (estimated)
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.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- 772 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Ngoc Vuong, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Tuan D Tran, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094635
- Sponsor's protocol ID
- 473/HDDD-DHYD
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Immunogenicity Against SARS-CoV-2 in the Community With Home-quarantined Covid-19 Patients in Ho Chi Minh City, Vietnam
- ClinicalTrials.gov ID
- NCT05094635
- Acronym / sponsor ID
- 473/HDDD-DHYD
- Conditions
- Covid19, Vaccine Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 26 Oct 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- People who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- 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.
Tuan D Tran, PhD principal investigator
Study Principal Investigator
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 University of Medicine and Pharmacy at Ho Chi Minh City 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: status not confirmed, as of the sponsor's last update on 1 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan TN Vuong, PhD (+84901183918, lanvuong@ump.edu.vn), or a site near the patient. 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 1 Nov 2021.