DANTE-SIRIO 8: Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| participants willing to receive a 3-dose vaccination schedule participants willing to receive a 3-dose vaccination schedule |
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
|
| participants unwilling to receive a 3rd dose of vaccination participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose |
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
|
Outcome Measures
Primary Outcome Measures
- the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine [0-12 months]
evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine
Secondary Outcome Measures
- the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle [0-12 months]
evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points in 2-dose vaccination schedule
- the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose [0-12 months]
evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points after 3rd dose of vaccine
- local and/or systemic adverse reactions after vaccination [0-12 months]
verification of any adverse events occurrence based on survey filled by participants on each visit
- confirmed COVID-19 after vaccination [0-12 months]
verification of COVID-19 based on survey filled by participants on each visit
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Transplantology and General Surgery, Dr. A. Jurasz University Hospital | Bydgoszcz | Poland |
Sponsors and Collaborators
- Collegium Medicum w Bydgoszczy
Investigators
- Study Director: Zbigniew Włodarczyk, Prof., Collegium Medicum w Bydgoszczy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DANTE-SIRIO 8