Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study

NCT05109585 | Unknown

• 1 other identifier: DANTE- SIRIO 7
• Study Type: observational
• Target: 1,000
• 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. We have designed the study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle 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 who received a 2-dose vaccination schedule, willing to receive a 3rd dose

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszczand students of Collegium Medicum, Nicolaus Copernicus University. Approximately1000 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

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)

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

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

• Jacek Kubica, Prof.

  Collegium Medicum w Bydgoszczy

  PRINCIPAL INVESTIGATOR

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: November 4, 2021
• First Posted: November 5, 2021
• Study Start: April 20, 2021
• Primary Completion: October 12, 2022
• Study Completion: December 31, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)