Official Title
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination in Patients After Organ Transplantation (DANTE-SIRIO 8) Study
Brief Summary

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 investigatorsdesigned a study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cyclewith the BNT162b2 vaccine in several time points relating these results to the COVID-19history and severity of symptoms during the disease and after the first and secondvaccine dose.

Detailed Description

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.

Unknown status
SARS-CoV2 Infection
SARS-CoV2 Antibodies

Diagnostic Test: 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

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Poland
Locations

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

Investigator: Emilia Wojtal, MD
Contact: +48 52 5854380
terenia4@interia.pl

Contacts

Emilia Wojtal, MD
+48 52 5854380
terenia4@interia.pl

Zbigniew Włodarczyk, Prof., Study Director
Collegium Medicum w Bydgoszczy

Collegium Medicum w Bydgoszczy
NCT Number
MeSH Terms
COVID-19
Antibodies
Immunoglobulins
Immunoglobulin G