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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 28, 2023

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine
    • Time Frame: 0-12 months
    • evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine

Secondary Measures

  • the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 0-12 months
    • verification of any adverse events occurrence based on survey filled by participants on each visit
  • confirmed COVID-19 after vaccination
    • Time Frame: 0-12 months
    • verification of COVID-19 based on survey filled by participants on each visit

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Collegium Medicum w Bydgoszczy
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacek Kubica, Professor – Collegium Medicum w Bydgoszczy
  • Overall Official(s)
    • Zbigniew Włodarczyk, Prof., Study Director, Collegium Medicum w Bydgoszczy
  • Overall Contact(s)
    • Emilia Wojtal, MD, +48 52 5854380, terenia4@interia.pl

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