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.
ID
Bron
Verkorte titel
Aandoening
End stage lung disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
Immune response to COVID-19 vaccination in lung transplantation patients
Doel van het onderzoek
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.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
SARS-CoV-2 vaccine (not study related), blood samples
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
● 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
● 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9538 |
| Ander register | METc UMCG : METc 2021/021 |