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Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study

NCT ID: NCT05109585

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-12-31

Brief Summary

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Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. We have designed the study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose

Detailed Description

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The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of Collegium Medicum, Nicolaus Copernicus University. To meet the inclusion criteria patients will have to be vaccinated with two doses of the BNT162b2 vaccine. The assessment of the anti-SARS-CoV-2 IgG antibody titer at several time points in each participant. Fresh serum samples were used to measure SARS-CoV-2 IgG on the Siemens Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG were given as U/ml, whereby the cut-off for positivity was defined as ≥1.0 U/ml.

Conditions

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SARS-CoV2 Infection SARS-CoV2 Antibodies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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participants willing to receive a 3-dose vaccination schedule

participants who received a 2-dose vaccination schedule, willing to receive a 3rd dose

assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule

Intervention Type DIAGNOSTIC_TEST

evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine

participants unwilling to receive a 3rd dose of vaccination

participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose

assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule

Intervention Type DIAGNOSTIC_TEST

evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine

Interventions

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assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule

evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine

Intervention Type DIAGNOSTIC_TEST

assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule

evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent to study
* Age ≥ 18 years
* Receiving two doses of the BNT162b2 vaccine

Exclusion Criteria

* patients who did not complete 2-dose vaccination schedule
* patients who received any other vaccine than BNT162b2
* patients considered by investigator to be unable to cooperate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Collegium Medicum w Bydgoszczy

OTHER

Sponsor Role lead

Responsible Party

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Jacek Kubica

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacek Kubica, Prof.

Role: PRINCIPAL_INVESTIGATOR

Collegium Medicum w Bydgoszczy

Locations

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Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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DANTE- SIRIO 7

Identifier Type: -

Identifier Source: org_study_id