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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04954651
Recruitment Status : Completed
First Posted : July 8, 2021
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Ioannis Habeos, University of Patras

Study Description
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Brief 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).

Condition or disease Intervention/treatment
SARS-CoV2 Infection Vaccine Reaction Biological: Approved vaccines against Sars-Cov2

Study Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received European Union (EU) -Approved COVID-19 Vaccines
Actual Study Start Date : July 7, 2021
Actual Primary Completion Date : March 28, 2022
Actual Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
VAC
Vaccinated subject against Sars-Cov2
 Biological: Approved vaccines against Sars-Cov2
Subjects who voluntarily are vaccinated against Sars-Cov-2 with any of the approved vaccines by EU


Outcome Measures
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Primary Outcome Measures :
  1. Antibody titer against Sars-Cov2 [ Time Frame: 0-9 months ]

Biospecimen Retention:   Samples Without DNA
Serum from patients

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who voluntarily receive COVID-19 vaccines
Criteria

Inclusion Criteria:

  • Subjects who voluntarily receive COVID-19 vaccination

Exclusion Criteria:

  • Patients who do not complete their vaccination
  • Patients who do not provide info on their health status
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04954651


Locations
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Greece
University Hospital of Patras
Patras, Greece, 26504
Sponsors and Collaborators
University of Patras
Investigators
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Principal Investigator: Ioannis Habeos, MD, PhD University of Patras
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ioannis Habeos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT04954651    
Other Study ID Numbers: 99-25/2/2021
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ioannis Habeos, University of Patras:
sars-cov2
vaccine
age
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases