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

NCT05162456 | Unknown

• 1 other identifier: DANTE-SIRIO 8
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection; SARS-CoV2 Antibodies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle

  0-12 months

• the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose

  0-12 months

• local and/or systemic adverse reactions after vaccination

  0-12 months

• confirmed COVID-19 after vaccination

  0-12 months

Study Arms (2)

participants willing to receive a 3-dose vaccination schedule

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

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

Interventions

assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule DIAGNOSTIC_TEST

evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine

participants willing to receive a 3-dose vaccination schedule

assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule DIAGNOSTIC_TEST

evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine

participants unwilling to receive a 3rd dose of vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Provision of informed consent to study
• Age ≥ 18 years
• Receiving two doses of the BNT162b2 vaccine
• patients post organ transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Department of Transplantology and General Surgery, Dr. A. Jurasz University Hospital

Bydgoszcz, Poland

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zbigniew Włodarczyk, Prof.

  Collegium Medicum w Bydgoszczy

  STUDY DIRECTOR

Central Study Contacts

Emilia Wojtal, MD

CONTACT

+48 52 5854380; terenia4@interia.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 17, 2021
• Study Start: July 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)