SARS-CoV2 InfectionNCT04954651
Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received EU-approved COVID-19 Vaccines
An observational study of SARS-CoV2 Infection and Vaccine Reaction, run by University of Patras at 1 site in Greece.
Trial summary
Patients who voluntarily visit vaccination centers in Greece against COVID-19 are recruited and their immunization levels against Sars-Cov2 are assesed by measurement of the levels of serum antibodies against Sars-cov-2 before vaccination and in time intervals up to 6-9 months post-vaccination (indicatively 0-1-3-6-9… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV2 Infection, Vaccine Reaction
- What is being tested?
- Approved vaccines against Sars-Cov2
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jul 2021to 28 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who voluntarily receive COVID-19 vaccines
Who may be able to join
- Subjects who voluntarily receive COVID-19 vaccination
Who cannot join
- Patients who do not complete their vaccination
- Patients who do not provide info on their health status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received European Union (EU) -Approved COVID-19 Vaccines
Patients who voluntarily visit vaccination centers in Greece against COVID-19 are recruited and their immunization levels against Sars-Cov2 are assesed by measurement of the levels of serum antibodies against Sars-cov-2 before vaccination and in time intervals up to 6-9 months post-vaccination (indicatively 0-1-3-6-9 months post-vaccination).
- Conditions
- SARS-CoV2 Infection, Vaccine Reaction
- Being tested
- Approved vaccines against Sars-Cov2
- Keywords
- sars-cov2, vaccine, age
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approved vaccines against Sars-Cov2Biological
Subjects who voluntarily are vaccinated against Sars-Cov-2 with any of the approved vaccines by EU
| Study group | Role | What they receive |
|---|---|---|
| VAC | Vaccinated subject against Sars-Cov2 Receives: Biological: Approved vaccines against Sars-Cov2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titer against Sars-Cov2
Measured: 0-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start7 Jul 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
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 SARS-CoV2 InfectionStudies 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
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Habeos, University of Patras
- Investigators
- Ioannis Habeos, MD, PhD, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954651
- Sponsor's protocol ID
- 99-25/2/2021
- Status last verified
- Jun 2022
- First submitted
- 6 Jul 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to make the coded individual participant data available to other researchers upon reasonable request after the publication of the study in a journal
Publications
Parthymou A, Habeos EE, Habeos GI, Deligakis A, Livieratos E, Marangos M, Chartoumpekis DV. Factors associated with anti-SARS-CoV-2 antibody titres 3 months post-vaccination with the second dose of BNT162b2 vaccine: a longitudinal observational cohort study in western Greece. BMJ Open. 2022 May 19;12(5):e057084. doi: 10.1136/bmjopen-2021-057084.
PubMed 35589363
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received European Union (EU) -Approved COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT04954651
- Acronym / sponsor ID
- 99-25/2/2021
- Conditions
- SARS-CoV2 Infection, Vaccine Reaction
- Keywords
- sars-cov2, vaccine, age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 8 Jul 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.
Patients who voluntarily visit vaccination centers in Greece against COVID-19 are recruited and their immunization levels against Sars-Cov2 are assesed by measurement of the levels of serum antibodies against Sars-cov-2 before vaccination and in time intervals up to 6-9 months post-vaccination (indicatively 0-1-3-6-9 months post-vaccination).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAC | – | Biological: Approved vaccines against Sars-Cov2Vaccinated subject against Sars-Cov2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who voluntarily receive COVID-19 vaccines
Key inclusion criteria (1 listed)
- Subjects who voluntarily receive COVID-19 vaccination
Key exclusion criteria (2 listed)
- Patients who do not complete their vaccination
- Patients who do not provide info on their health status
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 |
|---|---|---|
| Approved vaccines against Sars-Cov2Subjects who voluntarily are vaccinated against Sars-Cov-2 with any of the approved vaccines by EU | Biological | VAC |
Primary outcome
Antibody titer against Sars-Cov2
Time frame: 0-9 months
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 6 Jun 2022.
- Derived from this study: PubMed 35589363Parthymou A, Habeos EE, Habeos GI, Deligakis A, Livieratos E, Marangos M, Chartoumpekis DV. Factors associated with anti-SARS-CoV-2 antibody titres 3 months post-vaccination with the second dose of BNT162b2 vaccine: a longitudinal observational cohort study in western Greece. BMJ Open. 2022 May 19;12(5):e057084. doi: 10.1136/bmjopen-2021-057084.
- Individual participant dataSharing planned: Undecided. We plan to make the coded individual participant data available to other researchers upon reasonable request after the publication of the study in a journal
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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.
Ioannis Habeos, MD, PhD principal investigator
University of Patras
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 SARS-CoV2 Infection and Vaccine Reaction, run by University of Patras at 1 site in Greece.
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 1 inclusion and 2 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 6 Jun 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 Greece. 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?
Antibody titer against Sars-Cov2 (time frame: 0-9 months). 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 NCT04954651, 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 6 Jun 2022.