Short summary

The SARS-CoV-2 spike messenger RNA (mRNA) vaccines are reported to prevent Covid-19 in 94-95% of adults after a two-dose regimen. However, the immunogenicity in solid organ transplant (SOT) recipients is currently unknown.

Our aim is to investigate the cellular and humoral immune response in SOT recipients following a two-dose regimen of Covid-19 vaccination.

Rationale

As a result of lifelong immunosuppressive treatment, SOT recipients are at higher risk of severe infections, including Covid-19.

The immunosuppressive treatment affects both the humoral and cellular immune responses with an expected reduced immune response to the Covid-19 vaccine in SOT recipients, as has been previously observed following influenza and pneumococcal vaccination.

Previous studies have shown SOT recipients have a decreased or no immune response following Covid-19 infection.

It is currently not well described if a two-dose regimen of a Covid-19 vaccine is sufficient to elicit an immune response in SOT recipients. We will investigate the immune response and duration of immunogenicity in SOT recipients following COVID-19 vaccines used in Denmark.

Description of the cohort

This is a prospective observational cohort study, with a study period from January 29, 2021 till June 30, 2023.

The study population consist of adult SOT recipients that are followed at the respective departments at Odense University Hospital under highly specialized service. At the moment there are registered 500 completed kidney transplantations (NTx), 117 liver transplantations (LeTx), 23 heart transplantations (HTx) and 23 lung transplantations (LTx) at Odense University Hospital.

Data and biological material

Blood samples will be drawn 4 weeks following the second vaccination and will be repeated will be repeated 3,6,12, 18 and 24 months after the first vaccine. The SARS-CoV-2 spike S1 IgG response will be measured using a commercial available assay.

Publications associated with the project

Immunogenicity of SARS-CoV-2 mRNA vaccine in solid organ transplant recipients. Holden IK, Bistrup C, Nilsson AC, Hansen JF, Abazi R, Davidsen JR, Poulsen MK, Lindvig SO, Justesen US, Johansen IS. J Intern Med. 2021 Jul 8:10.1111/joim.13361. doi: 10.1111/joim.13361. Online ahead of print. PMID: 34237179

Pedersen RM, Bang LL, Tornby DS, Kierkegaard H, Nilsson AC, Johansen IS, Bistrup C, Jensen TG, Justesen US, Andersen TE. The SARS-CoV-2-neutralizing capacity of kidney transplant recipients 4 weeks after receiving a second dose of the BNT162b2 vaccine. Kidney Int. 2021 Nov;100(5):1129-1131. doi: 10.1016/j.kint.2021.09.006. Epub 2021 Sep 20. PMID: 34547366; PMCID: PMC8450277.

Pedersen RM, Tornby DS, Bistrup C, Johansen IS, Andersen TE, Justesen US. Negative SARS-CoV-2 antibodies, T-cell response and virus neutralization following full vaccination in a renal transplant recipient: a call for vigilance. Clin Microbiol Infect. 2021 Sep;27(9):1371-1373. doi: 10.1016/j.cmi.2021.05.042. Epub 2021 Jun 7. PMID: 34111582; PMCID: PMC8180445.