Trials / Unknown
UnknownNCT05162456
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination in Patients After Organ Transplantation (DANTE-SIRIO 8) Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Collegium Medicum w Bydgoszczy · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2023-02-28
- Completion
- 2023-04-30
- First posted
- 2021-12-17
- Last updated
- 2021-12-17
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT05162456. Inclusion in this directory is not an endorsement.