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

Collegium Medicum w Bydgoszczy

Status: Unknown

Conditions: SARS-CoV2 Infection; SARS-CoV2 Antibodies

Treatments: Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule; Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule

Study type: Observational

Funder types: Other

Identifiers

NCT05162456

DANTE-SIRIO 8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

participants willing to receive a 3-dose vaccination schedule

Description:

participants willing to receive a 3-dose vaccination schedule

Treatment:

Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule

participants unwilling to receive a 3rd dose of vaccination

Description:

participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose

Treatment:

Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule