Investigating the immune response to COVID-19 Vaccination in Lung Transplantation patients (COVALENT study)

Lung transplant recipients are sensitive to respiratory virus infections due to
their immunocompromized status. A virus infection can cause direct harm to the
lungs, but additionally, damage may be caused by the inflammatory response,
which could lead to rejection of the transplanted organ..
The current COVID-19 pandemic is a threat to people with a lung transplant.
Patients with progressive lung failure who are on the waiting list for a
transplantation are even more at risk of a COVID-19 infection. The severity of
the infection could cause such a rapid decline in lung function that
transplantation may no longer be an option. Vaccination is therefore the only
way of reducing the risk.

The vaccins which have currently been approved in the EU have been shown to be
highly effective. From studies it is known that vaccinated individuals have
developed efficient immune responses, with development of both antibodies and
T-cells.
Unfortunately however, these vaccines have not been tested in lung transplant
recipients. From studies investigating other vaccines it is known that these
lung transplant recipients have reduced responses to vaccines, as is the case
e.g. for the Influenza vaccine.
People who are on the waiting list still have normal immmune responses to
vaccination. In this group we don't know if the immunity acquired after
vaccination is sustained after transplantation. This is what we intend to
investigate.

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.

In this observational cohort study, we aim to determine the immune response of
lung transplantation recipients to SARS-CoV-2 vaccination by measuring
antibodies and T-cell responses at different time points.
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 participants are going to receive the SARS-CoV-2 vaccine according to the
manufacturer*s instructions. This vaccine is part of standard care. At time of
inclusion and after baseline samples are taken, participants are going to
receive the first vaccine dose which is supplied by the RIVM for the purpose of
this study.

SARS-CoV-2 vaccine candidates have recently been evaluated for authorization by
the European Medicines Agency. However, immunosuppressed patients, have been
excluded from SARS-CoV-2 vaccination trials so-far. Therefore, a study to
assess vaccine efficacy in these specific patient populations is of great
importance, also because these patients are at the highest risk for a severe
course of COVID-19. We will monitor and report AEs related to SARS-CoV-2
vaccination. Patients will be offered vaccination, regardless whether they will
participate in this study or not. Vaccination is therefore not a study related
procedure per sé. Study related procedures involve blood withdrawal, and
potentially nasopharyngeal sampling. These are not considered a high-risk
action, and in many cases this can be combined with routine blood drawings for
diagnostic purposes. There is no direct benefit to the study participants.
However, this study will provide highly valuable information about
effectiveness of COVID-19 vaccination in this highly immunosuppressed
population.
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