Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation

• Conditions: SARS-CoV2 Antibodies; SARS-CoV2 Infection
• Interventions: 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

• Registration Number: NCT05162456
• Lead Sponsor: Collegium Medicum w Bydgoszczy

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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Last Update Submitted: 2021-12-15
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17
• Primary Completion: 2023-02-28
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
participants unwilling to receive a 3rd dose of vaccination	assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule	participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose
participants willing to receive a 3-dose vaccination schedule	assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule	participants willing to receive a 3-dose vaccination schedule

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
confirmed COVID-19 after vaccination	0-12 months	verification of COVID-19 based on survey filled by participants on each visit
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

Trial Locations

Locations (1)

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