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Lung transplantation patients are immunocompromised due to antirejection therapy. The effectivity of the COVID-19 vaccination in this high-risk patient group is completely unknown.

Objective: To investigate the humoral and cellular immune response, and the development of immunological memory to the COVID-19 vaccination in lung transplantation patients. To clarify firstly if immunity develops in these patients and secondly, if the immune response lasts for 1 year.

This is an observational study of the development of humoral and cellular immune responses following COVID-19 vaccination. Baseline samples are taken from participants prior to first vaccination, and these participants are sampled at regular intervals, until a year after vaccination. A group of patients who are on the lung transplant waiting list are immunized and followed at regular intervals. Following transplantation, the observation time is extended to six months after transplantation. Patient characteristics, potential side effects of vaccination, lung function and degree of immunosuppression will be collected.

Study population: Three groups will be studied:

1) Adult lung transplant recipients who are going to be vaccinated against SARS-CoV-2.

2) Adult lung transplant waiting list patients who are going to be vaccinated against SARS-CoV-2.

3) Adult lung transplant recipients with past COVID-19 infections, who are going to be vaccinated against SARS-CoV-2.

Healthy control patients are not included in this study, as they are already a part of the RECOVAC study which investigates the effects of SARS-CoV-2 vaccination in patients with renal disease.

The primary study parameter is the antibody response to SARS-CoV-2 in immunized individuals with lung transplantation, defined as an increase compared to reference serum, at 28 days, 6 months and 12 months after vaccination. The secondary study parameters are: 1) To determine if immunity obtained by vaccination on the waiting list is sustained after lung transplantation 2) SARS-CoV-2 specific T-cell response at baseline, at 28 days, and 6 and 12 months after the second vaccination 3) To assess the possible adverse events as a result of vaccination. 4) IFN- ? production measured by SARS-CoV-2 Quantiferon test at baseline, 28 days, 6 months and 12 months after the second vaccination. 5) To determine if COVID-19 infections occur in the vaccinated participants, and to look for correlations in the measured antibody and T-cell responses. 6) To investigate if the immune response to vaccination correlates with the degree of immunosuppression, reflected in e.g. medication dosages, trough levels and the Torque Teno Virus (TTV) levels found in the participants. 7) to investigate the safety, side effects and immunogenicity of SARS-CoV-2 vaccination in lung transplant recipients who have had the infection and who have recovered.

 

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