No registrations found.
ID
Source
Brief title
Health condition
End stage lung disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the antibody response of lung transplantation recipients and patients who are on the waiting list for lung transplantation, to the SARS-CoV-2 vaccine at 28 days, 6 months and 12 months after the second vaccine dose, compared to the immune response of healthy individuals. Healthy individuals are part of the RECOVAC study (METC approved on 23rd December 2020).
Secondary outcome
1) To determine the antibody response of patients who are on the waiting list for lung transplantation, to the SARS-CoV-2 vaccine at 28 days, 6 months and 12 months after the second vaccine dose, or 3 and 6 months after lung transplantation, depending on when the transplantation takes place, to establish if immunity which is generated prior to transplantation, is sustained after lung transplantation.
2) To determine the T-cell immune responses of lung transplantation recipients, and patients on the waiting list for lung transplantation, to the SARS-CoV-2 vaccine, measured by ELIspot and FACS analysis.
3) To assess adverse events to vaccination.
Background summary
Immune response to COVID-19 vaccination in lung transplantation patients
Study objective
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.
Study design
Screen/vaccination 1, week 4 vaccination 2, vaccination 2+28 days, vaccination 2+6 months, vaccination 2+12 months, Patients who are vaccinated while on the waiting list receive a transplantation: 3 and 6 months from transplantation
Intervention
SARS-CoV-2 vaccine (not study related), blood samples
Inclusion criteria
● All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
● Provision of written informed consent
● ≥18 years of age
● Belong to one of the four populations as named in 4.1.
Exclusion criteria
● Contra-indications for vaccination (unrelated to the study)
-History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
-Pregnancy at the time of the vaccinations
● Exclusion specific to this investigation
-No administration of SARS-CoV-2 vaccine due to any reason
-Active (hematological) malignancy
-Inherited immune deficiency
-Receiving anti-retroviral medication o Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
-Waitlist patients with a passed COVID-19 infection.
-Transplantation candidates who do not receive a transplantation within 15 months after receiving the second vaccination dose will remain included as controls. However, sampling will not continue after long
transplantation if the transplant occurs at a later time.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9538 |
| Other | METc UMCG : METc 2021/021 |