Clinical trial NCT05109585: Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study
Official title: Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) 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: 2021-11-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszczand students of Collegium Medicum, Nicolaus Copernicus University.

Approximately1000 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. 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: 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.

Eligibility criteria: 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

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: Cardiology Department, Dr. A. Jurasz University Hospital
state: Kujawsko-Pomorskie
Study officials:
affiliation: Collegium Medicum w Bydgoszczy
name: Jacek Kubica, Prof.
role: PRINCIPAL_INVESTIGATOR
References: