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

Author

Listed:
  • 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)

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.

Suggested Citation

  • Daniel Mrak & Daniela Sieghart & Elisabeth Simader & Selma Tobudic & Helga Radner & Peter Mandl & Lisa Göschl & Maximilian Koblischke & Nikolaus Hommer & Angelika Wagner & Margareta Mayer & Lorenz Sch, 2022. "Heterologous vector versus homologous mRNA COVID-19 booster vaccination in non-seroconverted immunosuppressed patients: a randomized controlled trial," Nature Communications, Nature, vol. 13(1), pages 1-9, December.
  • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-33036-y
    DOI: 10.1038/s41467-022-33036-y
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    References listed on IDEAS

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    1. Roanne Keeton & Marius B. Tincho & Amkele Ngomti & Richard Baguma & Ntombi Benede & Akiko Suzuki & Khadija Khan & Sandile Cele & Mallory Bernstein & Farina Karim & Sharon V. Madzorera & Thandeka Moyo-, 2022. "T cell responses to SARS-CoV-2 spike cross-recognize Omicron," Nature, Nature, vol. 603(7901), pages 488-492, March.
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