- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109585
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study (DANTE-SIRIO 7)
November 4, 2021 updated by: Jacek Kubica, Collegium Medicum w Bydgoszczy
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) 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.
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
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of Collegium Medicum, Nicolaus Copernicus University.
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)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kujawsko-Pomorskie
-
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-094
- Cardiology Department, Dr. A. Jurasz University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Provision of informed consent to study
- Age ≥ 18 years
- Receiving two doses of the BNT162b2 vaccine
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
participants unwilling to receive a 3rd dose of vaccination
participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose
|
evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine
|
participants willing to receive a 3-dose vaccination schedule
participants who received a 2-dose vaccination schedule, willing to receive a 3rd dose
|
evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing 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
Time Frame: 0-12 months
|
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
Time Frame: 0-12 months
|
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
Time Frame: 0-12 months
|
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
Time Frame: 0-12 months
|
verification of any adverse events occurrence based on survey filled by participants on each visit
|
0-12 months
|
confirmed COVID-19 after vaccination
Time Frame: 0-12 months
|
verification of COVID-19 based on survey filled by participants on each visit
|
0-12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacek Kubica, Prof., Collegium Medicum w Bydgoszczy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2021
Primary Completion (Anticipated)
October 12, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
November 4, 2021
First Submitted That Met QC Criteria
November 4, 2021
First Posted (Actual)
November 5, 2021
Study Record Updates
Last Update Posted (Actual)
November 5, 2021
Last Update Submitted That Met QC Criteria
November 4, 2021
Last Verified
November 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 7
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SARS-CoV2 Infection
-
Centre Hospitalier Universitaire DijonUnknown
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Meshalkin Research Institute of Pathology of CirculationUnknown
-
Collegium Medicum w BydgoszczyRecruitingSARS-CoV2 Infection | SARS-CoV2 AntibodiesPoland
-
University Hospital, LilleFondation Santé RoquetteCompleted
-
University of AarhusCompleted
-
University Hospital, LilleFondation Santé RoquetteUnknown
-
Medical University of ViennaWithdrawnSars-CoV2 | Prophylaxis | Infection Viral | Healthcare Worker
-
Colorado School of Public HealthUniversity of Colorado, Denver; University of Colorado, Boulder; Colorado State... and other collaboratorsRecruitingCOVID-19 | SARS-CoV2 InfectionUnited States
-
Rutgers, The State University of New JerseyNational Institute of Dental and Craniofacial Research (NIDCR)Completed
Clinical Trials on assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule
-
Collegium Medicum w BydgoszczyRecruitingSARS-CoV2 Infection | SARS-CoV2 AntibodiesPoland
-
Institut National de la Santé Et de la Recherche...Completed
-
Sinovac Research and Development Co., Ltd.Completed
-
Jiangsu Province Centers for Disease Control and...Academy of Military Medical Sciences,Academy of Military Sciences,PLA; ZHONGYIANKE... and other collaboratorsRecruiting
-
Jiangsu Province Centers for Disease Control and...West China HospitalCompleted
-
Moscow Department of HealthMoscow State University of Medicine and Dentistry; National Research Center... and other collaboratorsCompletedCovid19 | Respiratory Viral InfectionRussian Federation
-
Abbott Rapid Diagnostics Jena GmbHCompletedCOVID-19 Respiratory InfectionUnited States
-
Sinovac Research and Development Co., Ltd.CompletedStudy on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza VaccineCOVID-19 | InfluenzaChina
-
Vilnius UniversityRecruitingAnalysis of Immunogenicity, Safety and Efficacy of COVID-19 Vaccines in Immunosuppressed IndividualsHematologic Neoplasms | COVID-19 VaccinesLithuania
-
Northwestern UniversityFoundation for Sarcoidosis ResearchRecruitingSARS-CoV2 Infection | Sarcoidosis | Vaccine Response ImpairedUnited States