NL-OMON22289
Completed
Not Applicable
Investigating the immune response to COVID-19 vaccination in lung transplantation patients (COVALENT study)
niversity Medical Center Groningen (UMCG)0 sites180 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Center Groningen (UMCG)
- Enrollment
- 180
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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