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

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

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.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV2 Infection; SARS-CoV2 Antibodies
• Intervention / Treatment: Diagnostic test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule; Diagnostic test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Emilia Wojtal, MD; Phone Number: +48 52 5854380; Email: terenia4@interia.pl

Study Locations

• Poland
  • Bydgoszcz, Poland
    • Recruiting
    • Department of Transplantology and General Surgery, Dr. A. Jurasz University Hospital
    • Contact: Emilia Wojtal, MD; Phone Number: +48 52 5854380; Email: terenia4@interia.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
participants willing to receive a 3-dose vaccination schedule	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
participants unwilling to receive a 3rd dose of vaccination; participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle	evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points in 2-dose vaccination schedule	0-12 months
the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose	evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points after 3rd dose of vaccine	0-12 months
local and/or systemic adverse reactions after vaccination	verification of any adverse events occurrence based on survey filled by participants on each visit	0-12 months
confirmed COVID-19 after vaccination	verification of COVID-19 based on survey filled by participants on each visit	0-12 months

Collaborators and Investigators

• Sponsor: Collegium Medicum w Bydgoszczy
• Investigators: Study Director: Zbigniew Włodarczyk, Prof., Collegium Medicum w Bydgoszczy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulin G
• Other Study ID Numbers: DANTE-SIRIO 8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No