Heterologous vector versus homologous mRNA COVID-19 booster vaccination in non-seroconverted immunosuppressed patients: a randomized controlled trial

Daniel Mrak, Daniela Sieghart, Elisabeth Simader, Selma Tobudic, Helga Radner, Peter Mandl, Lisa Göschl, Maximilian Koblischke, Nikolaus Hommer, Angelika Wagner, Margareta Mayer, Lorenz Schubert, Lukas Hartl, Karin Kozbial, Philipp Hofer, Felix Kartnig, Thomas Hummel, Andreas Kerschbaumer, Thomas Deimel, Antonia Puchner, Venugopal Gudipati, Renate Thalhammer, Petra Munda, Keziban Uyanik-Ünal, Andreas Zuckermann, Gottfried Novacek, Thomas Reiberger, Erika Garner-Spitzer, Roman Reindl-Schwaighofer, Renate Kain, Stefan Winkler, Josef S. Smolen, Karin Stiasny, Gottfried F. Fischer, Thomas Perkmann, Helmuth Haslacher, Markus Zeitlinger, Ursula Wiedermann, Judith H. Aberle, Daniel Aletaha, Leonhard X. Heinz () and Michael Bonelli ()
Additional contact information
Daniel Mrak: Medical University of Vienna
Daniela Sieghart: Medical University of Vienna
Elisabeth Simader: Medical University of Vienna
Selma Tobudic: Medical University of Vienna
Helga Radner: Medical University of Vienna
Peter Mandl: Medical University of Vienna
Lisa Göschl: Medical University of Vienna
Maximilian Koblischke: Medical University of Vienna
Nikolaus Hommer: Medical University of Vienna
Angelika Wagner: Medical University Vienna
Margareta Mayer: Medical University of Vienna
Lorenz Schubert: Medical University of Vienna
Lukas Hartl: Medical University of Vienna
Karin Kozbial: Medical University of Vienna
Philipp Hofer: Medical University of Vienna
Felix Kartnig: Medical University of Vienna
Thomas Hummel: Medical University of Vienna
Andreas Kerschbaumer: Medical University of Vienna
Thomas Deimel: Medical University of Vienna
Antonia Puchner: Medical University of Vienna
Venugopal Gudipati: Medical University of Vienna
Renate Thalhammer: Medical University of Vienna
Petra Munda: Medical University of Vienna
Keziban Uyanik-Ünal: Medical University of Vienna
Andreas Zuckermann: Medical University of Vienna
Gottfried Novacek: Medical University of Vienna
Thomas Reiberger: Medical University of Vienna
Erika Garner-Spitzer: Medical University Vienna
Roman Reindl-Schwaighofer: Medical University of Vienna
Renate Kain: Medical University of Vienna
Stefan Winkler: Medical University of Vienna
Josef S. Smolen: Medical University of Vienna
Karin Stiasny: Medical University of Vienna
Gottfried F. Fischer: Medical University of Vienna
Thomas Perkmann: Medical University of Vienna
Helmuth Haslacher: Medical University of Vienna
Markus Zeitlinger: Medical University of Vienna
Ursula Wiedermann: Medical University Vienna
Judith H. Aberle: Medical University of Vienna
Daniel Aletaha: Medical University of Vienna
Leonhard X. Heinz: Medical University of Vienna
Michael Bonelli: Medical University of Vienna

Nature Communications, 2022, vol. 13, issue 1, 1-9

Abstract: Abstract Impaired response to COVID-19 vaccination is of particular concern in immunosuppressed patients. To determine the best vaccination strategy for this vulnerable group we performed a single center, 1:1 randomized blinded clinical trial. Patients who failed to seroconvert upon two mRNA vaccinations (BNT162b2 or mRNA-1273) are randomized to receive either a third dose of the same mRNA or the vector vaccine ChAdOx1 nCoV-19. Primary endpoint is the difference in SARS-CoV-2 spike antibody seroconversion rate between vector and mRNA vaccinated patients four weeks after the third dose. Secondary outcomes include cellular immune responses. Seroconversion rates at week four are significantly higher in the mRNA (homologous vaccination, 15/24, 63%) as compared to the vector vaccine group (heterologous vaccination, 4/22, 18%). SARS-CoV-2-specific T-cell responses are reduced but could be increased after a third dose of either vector or mRNA vaccine. In a multivariable logistic regression analysis, patient age and vaccine type are associated with seroconversion. No serious adverse event is attributed to COVID-19 booster vaccination. Efficacy and safety data underline the importance of a booster vaccination and support the use of a homologous mRNA booster vaccination in immunosuppressed patients. Trial registration: EudraCT No.: 2021-002693-10.

Date: 2022
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DOI: 10.1038/s41467-022-33036-y

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