NCT04954651

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

July 6, 2021

Last Update Submit

June 2, 2022

Conditions

SARS-CoV2 InfectionVaccine Reaction

Keywords

sars-cov2vaccineage

Outcome Measures

Primary Outcomes (1)

  • Antibody titer against Sars-Cov2

    0-9 months

Study Arms (1)

VAC

Vaccinated subject against Sars-Cov2

Biological: Approved vaccines against Sars-Cov2

Interventions

Approved vaccines against Sars-Cov2BIOLOGICAL

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

VAC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who voluntarily receive COVID-19 vaccines

You may qualify if:

  • Subjects who voluntarily receive COVID-19 vaccination

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, 26504, Greece

Location

Related Publications (1)

  • 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.

    PMID: 35589363DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from patients

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ioannis Habeos, MD, PhD

    University of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 8, 2021

Study Start

July 7, 2021

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

GR(1)