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Efficacy and safety of SARS-CoV-2 revaccination in non-responders with immune-mediated inflammatory disease
  1. David Simon1,2,
  2. Koray Tascilar1,2,
  3. Filippo Fagni1,2,
  4. Katja Schmidt1,2,
  5. Gerhard Krönke1,2,
  6. Arnd Kleyer1,2,
  7. Andreas Ramming1,2,
  8. Verena Schoenau1,2,
  9. Daniela Bohr1,2,
  10. Johannes Knitza1,2,
  11. Thomas Harrer1,2,
  12. Karin Manger3,
  13. Bernhard Manger1,2,
  14. Georg Schett1,2
  1. 1 Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander University Erlangen-Nuremberg and Universiätsklinikum Erlangen, Erlangen, Germany
  2. 2 Deutsches Zentrum Immuntherapie, Friedrich-Alexander University Erlangen-Nuremberg and Universiätsklinikum Erlangen, Erlangen, Germany
  3. 3 Rheumatology Practice Bamberg, Erlangen, Germany
  1. Correspondence to Professor Georg Schett, Department of Internal Medicine 3 – Rheumatology and Immunology, Universitätsklinikum Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen 91054, Bayern, Germany; georg.schett{at}


Objectives To test whether patients with immune-mediated inflammatory disease (IMIDs), who did not respond to two doses of the SARS-CoV-2 vaccine, develop protective immunity, if a third vaccine dose is administered.

Methods Patients with IMID who failed to seroconvert after two doses of SARS-CoV-2 vaccine were subjected to a third vaccination with either mRNA or vector-based vaccines. Anti-SARS-CoV-2 IgG, neutralising activity and T cell responses were assessed at baseline and 3 weeks after revaccination and also evaluated seprarately in rituximab (RTX) and non-RTX exposed patients.

Results 66 non-responders were recruited, 33 treated with RTX, and 33 non-exposed to RTX. Overall, 49.2% patients seroconverted and 50.0% developed neutralising antibody activity. Seroconversion (78.8% vs 18.2%) and neutralising activity (80.0% vs 21.9%) was higher in non-RTX than RTX-treated patients with IMID, respectively. Humoral vaccination responses were not different among patients showing positive (59.3%) or negative (49.7%) T cell responses at baseline. Patients remaining on mRNA-based vaccines showed similar vaccination responses compared with those switching to vector-based vaccines.

Conclusions Overall, these data strongly argue in favor of a third vaccination in patients with IMID lacking response to standard vaccination irrespective of their B cell status.

  • antirheumatic agents
  • biological therapy
  • COVID-19

Data availability statement

Data are available on reasonable request. N/A.

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Data availability statement

Data are available on reasonable request. N/A.

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  • Handling editor Johannes WJ Bijlsma

  • DS, KT and FF contributed equally.

  • Contributors Study design: DS, KT, BM, GK and GS. Sample collection: DS, AK, AR, VS, DB, JK and KM. Experiments and data analysis: DS, KT, KS, FF, KT and TH. Data interpretation: DS, KT, FF and GS. Writing of the manuscript: DS, KT, FF and GS. Critical proof reading of the manuscript: all authors. GS accepts full responsibility for the work and/or the conduct of the study, had access to the data and controlled the decision to publish.

  • Funding The study was supported by the Deutsche Forschungsgemeinschaft (DFG-FOR2886 PANDORA and the CRC1181 Checkpoints for Resolution of Inflammation). Additional funding was received by the Bundesministerium für Bildung und Forschung (BMBF; project MASCARA), the ERC Synergy grant 4D Nanoscope, the IMI funded project RTCure, the Emerging Fields Initiative MIRACLE of the Friedrich-Alexander-Universität Erlangen-Nürnberg, and the Else Kröner-Memorial Scholarship (DS, no. 2019_EKMS.27). KS was supported by the Hector foundation (project M2102).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.