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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52266

Enrollment

180

Registered

2021-02-17

Start date

2021-02-23

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung transplantation

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Lung transplant recipients AND patients on witing list for lung trasnplantation willing to be vaccinated against COVID-19

Exclusion criteria

Exclusion criteria: History of severe adverse reacton to a vaccine Waitlist patients with passed COVID-19 infections active malignancy Inherited immune deficiency

Design outcomes

Primary

Measure	Time frame
The primary study parameter is the antibody response to SARS-CoV-2 in immunized individuals with lung transplantation, defined as an increase compared to reference serum, at 28 days, 6 months and 12 months after vaccination.	—

Secondary

Measure	Time frame
The secondary study parameters are: 1) To determine if immunity obtained by vaccination on the waiting list is sustained after lung transplantation 2) SARS-CoV-2 specific T-cell response at baseline, at 28 days, and 6 and 12 months after the second vaccination 3) To assess the possible adverse events as a result of vaccination. 4) IFN- * production measured by SARS-CoV-2 Quantiferon test at baseline, 28 days, 6 months and 12 months after the second vaccination. 5) To determine if COVID-19 infections occur in the vaccinated participants, and to look for correlations in the measured antibody and T-cell responses. 6) To investigate if the immune response to vaccination correlates with the degree of immunosuppression, reflected in e.g. medication dosages, trough levels and the Torque Teno Virus (TTV) levels found in the participants. 7) to investigate the safety, side effects and immunogenicity of SARS-CoV-2 vaccination in lung transplant recipients who have had the infection and who have recovered.	—

Measure

Time frame

The secondary study parameters are: 1) To determine if immunity obtained by vaccination on the waiting list is sustained after lung transplantation 2) SARS-CoV-2 specific T-cell response at baseline, at 28 days, and 6 and 12 months after the second vaccination 3) To assess the possible adverse events as a result of vaccination. 4) IFN- * production measured by SARS-CoV-2 Quantiferon test at baseline, 28 days, 6 months and 12 months after the second vaccination. 5) To determine if COVID-19 infections occur in the vaccinated participants, and to look for correlations in the measured antibody and T-cell responses. 6) To investigate if the immune response to vaccination correlates with the degree of immunosuppression, reflected in e.g. medication dosages, trough levels and the Torque Teno Virus (TTV) levels found in the participants. 7) to investigate the safety, side effects and immunogenicity of SARS-CoV-2 vaccination in lung transplant recipients who have had the infection and who have recovered.

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Countries

Netherlands

Outcome results