Investigating the immune response to COVID-19 vaccination in lung transplantation patients (COVALENT study)
- Conditions
- End stage lung disease
- Registration Number
- NL-OMON22289
- Lead Sponsor
- niversity Medical Center Groningen (UMCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
? 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.
? 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.<br>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.<br>3) To assess adverse events to vaccination.