Clinical trial NCT05162456: Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation
Official title: Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination in Patients After Organ Transplantation (DANTE-SIRIO 8) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV2 Infection
SARS-CoV2 Antibodies
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study patients of Antoni Jurasz University Hospital No.1 in Bydgoszcz who underwent organ transplantation.

Approximately 250 adult participants are planned to be included in the 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 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: 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.

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

Primary outcomes:
measure: the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine
timeFrame: 0-12 months
Secondary outcomes:
measure: the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle
timeFrame: 0-12 months
measure: the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose
timeFrame: 0-12 months
measure: local and/or systemic adverse reactions after vaccination
timeFrame: 0-12 months
measure: confirmed COVID-19 after vaccination
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Transplantology and General Surgery, Dr. A. Jurasz University Hospital
Study officials:
affiliation: Collegium Medicum w Bydgoszczy
name: Zbigniew Włodarczyk, Prof.
role: STUDY_DIRECTOR
References: