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Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation

NCT ID: NCT05162456

Last Updated: 2021-12-17

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

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-04-30

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. The investigators designed a study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle with 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 patients of Antoni Jurasz University Hospital No.1 in Bydgoszcz after organ transplantation. 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 willing to receive a 3-dose vaccination schedule

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
* patients post organ transplantation

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

No

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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Zbigniew Włodarczyk, Prof.

Role: STUDY_DIRECTOR

Collegium Medicum w Bydgoszczy

Locations

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Department of Transplantology and General Surgery, Dr. A. Jurasz University Hospital

Bydgoszcz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Emilia Wojtal, MD

Role: CONTACT

Phone: +48 52 5854380

Email: [email protected]

Facility Contacts

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Emilia Wojtal, MD

Role: primary

Other Identifiers

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DANTE-SIRIO 8

Identifier Type: -

Identifier Source: org_study_id