ClinicalTrials.gg
CompletedNCT04954651Updated Jun 6, 2022

Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received EU-approved COVID-19 Vaccines

An observational study in SARS-CoV2 Infection and Vaccine Reaction, sponsored by University of Patras. Completed at 1 site in Greece. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by University of Patras · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
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Study 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 months post-vaccination).

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Conditions studied

  • SARS-CoV2 Infection
  • Vaccine Reaction

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Keywords

  • sars-cov2
  • vaccine
  • age
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In context

COVID-19

7,776 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 1,000 is above the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Patras is the lead sponsor of 70 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects who voluntarily receive COVID-19 vaccines

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects who voluntarily receive COVID-19 vaccination

Exclusion criteria

Exclusion Criteria:

  • Patients who do not complete their vaccination
  • Patients who do not provide info on their health status
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • VAC

    Vaccinated subject against Sars-Cov2

    Biological: Approved vaccines against Sars-Cov2

Interventions

  • BiologicalApproved vaccines against Sars-Cov2

    Subjects who voluntarily are vaccinated against Sars-Cov-2 with any of the approved vaccines by EU

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What researchers measure

Primary outcomes

  1. Antibody titer against Sars-Cov2

    Time frame: 0-9 months

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Study locations

1 site
  • University Hospital of Patras
    Pátrai, 26504, Greece
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References and documents

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 ↗

Individual participant data

Plan to share: 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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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Mar 2022, 8 months.

Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 8 months is below that.

Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2021
First posted
Jul 8, 2021
StartActual
Jul 7, 2021
Primary completionActual
Mar 28, 2022
CompletionActual
Mar 28, 2022
Last update
Jun 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04954651
Lead sponsor
University of Patras
Responsible party
Ioannis Habeos (Professor, University of Patras) — Principal investigator
First posted
Jul 8, 2021
Start date
Jul 7, 2021
Primary completion
Mar 28, 2022
Completion
Mar 28, 2022
Last update
Jun 6, 2022

Study contacts

Ioannis Habeos, MD, PhD
principal investigator · University of Patras

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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