Covid19NCT04871945
Protective Antibody Level After COVID-19 Vaccination Among Patients Under Hemodialysis
An observational study of Covid19 and Vaccine Reaction, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Vaccine Reaction, Hemolysis
- What is being tested?
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA)
- Type of treatment
- Vaccines
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2021to 31 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients group : Patients under hemodialysis Control group : Healthy population
Who may be able to join
- The person who is vaccinated with ChAdOx1 (COVID-19 vaccine)
- The person who agrees with the protocol of the study
Who cannot join
- Age < 18 years
- Pregnants
- Experience of COVID-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Protective Antibody Production After COVID-19 Vaccination Among Patients Under Hemodialysis
The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.
- Conditions
- Covid19, Vaccine Reaction, Hemolysis, End-stage Renal Disease
- Being tested
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA)
- Medical subject headings
- COVID-19, Hemolysis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA)Diagnostic test
The antibody level will be measured by the above mentioned methods. The trial drugs are not used but the vaccine that included in National Immunization Program for COVID-19 in Korea will be used for the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the level of neutralizing antibody against SARS-CoV-2
Measured: Day 0, 14, 28, 56, 91, 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start20 Apr 2021
- Primary completion30 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seegene Medical Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871945
- Sponsor's protocol ID
- 2021-02-033
- Status last verified
- Mar 2021
- First submitted
- 29 Apr 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park JS, Minn D, Hong S, Jeong S, Kim S, Lee CH, Kim B. Immunogenicity of COVID-19 Vaccination in Patients With End-Stage Renal Disease Undergoing Maintenance Hemodialysis: The Efficacy of a Mix-and-Match Strategy. J Korean Med Sci. 2022 Jun 13;37(23):e180. doi: 10.3346/jkms.2022.37.e180.
PubMed 35698835
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protective Antibody Production After COVID-19 Vaccination Among Patients Under Hemodialysis
- ClinicalTrials.gov ID
- NCT04871945
- Acronym / sponsor ID
- 2021-02-033
- Conditions
- Covid19, Vaccine Reaction, Hemolysis, End-stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Seegene Medical Foundation
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 4 May 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.
The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients group : Patients under hemodialysis Control group : Healthy population
Key inclusion criteria (2 listed)
- The person who is vaccinated with ChAdOx1 (COVID-19 vaccine)
- The person who agrees with the protocol of the study
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnants
- Experience of COVID-19 infection
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 |
|---|---|---|
| Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA)The antibody level will be measured by the above mentioned methods. The trial drugs are not used but the vaccine that included in National Immunization Program for COVID-19 in Korea will be used for the study. | Diagnostic test | – |
Primary outcome
The change in the level of neutralizing antibody against SARS-CoV-2
Time frame: Day 0, 14, 28, 56, 91, 120
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 17 Mar 2022.
- Derived from this study: PubMed 35698835Park JS, Minn D, Hong S, Jeong S, Kim S, Lee CH, Kim B. Immunogenicity of COVID-19 Vaccination in Patients With End-Stage Renal Disease Undergoing Maintenance Hemodialysis: The Efficacy of a Mix-and-Match Strategy. J Korean Med Sci. 2022 Jun 13;37(23):e180. doi: 10.3346/jkms.2022.37.e180.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hanyang University Seoul Hospital at 1 site in South Korea.
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 2 inclusion and 3 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 17 Mar 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 South Korea. 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?
The change in the level of neutralizing antibody against SARS-CoV-2 (time frame: Day 0, 14, 28, 56, 91, 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871945, which also lists 1 linked publication.
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 17 Mar 2022.