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Abstract
Objectives A third COVID-19 vaccination is recommended for immunosuppressed patients. However, data on immunogenicity and safety of a third COVID-19 vaccination in patients with immune-mediated inflammatory diseases (IMIDs) are sparse and therefore addressed within this clinical trial.
Methods 60 immunosuppressed patients and 48 healthy controls (HCs) received a third vaccination with an mRNA vaccine. The primary endpoint was defined as the presence of antibody levels against the receptor-binding domain (RBD)>1500 BAU/mL in patients with IMIDs versus HCs. Further endpoints included differences in neutralising antibodies and cellular immune responses after the third vaccination. Reactogenicity was recorded for 7 days, and safety was evaluated until week 4.
Results Rate of individuals with anti-RBD antibodies>1500 BAU/mL was not significantly different after the third vaccination between patients with IMIDs and HCs (91% vs 100% p=0.101). Anti-RBD and neutralising antibody levels were significantly lower in patients with IMIDs after the third vaccination than in HCs (p=0.002 and p=0.016, respectively). In contrast, fold increase in antibody levels between week 0 and 4 was higher in patients with IMIDs. Treatment with biological (b) disease-modifying anti-rheumatic drugs (DMARD) or combination of bDMARDs and conventional synthetic DMARDs was associated with reduced antibody levels. Enhanced cellular immune response to wild type and Omicron peptide stimulation was observed after the third vaccination. No serious adverse event was attributed to the third vaccination.
Conclusion Our clinical trial data support the immunogenicity and safety of a third COVID-19 vaccination in patients with IMIDs. However, effects of DMARD therapy on immunogenicity should be considered.
Trial registration number EudraCT No: 2021-002693-10.
- Covid-19
- Vaccination
- Autoimmune Diseases
Data availability statement
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Data are available upon reasonable request. Anonymised data will be available upon request.
Footnotes
Handling editor David S Pisetsky
FK and DM contributed equally.
DS and MB contributed equally.
Contributors DS, ST, HR, PM, DM, MB and DA contributed to the study design. FK, DM, ES, LG, NH, TH, TD, IG, AP, AK, AH and MB recruited participants, performed patient visits and recorded data. MM, PH were relevant for sample handling and performed analysis. TP, HH and KS performed antibody measurements. JHA, MM and PH contributed to cellular assays. FK and DM performed data analysis and HR, DS, LXH and MB reviewed the data analysis. All authors contributed to the manuscript writing. MB is the guarantor.
Funding Provision of vaccines and laboratory testing was provided free of charge by the city of Vienna and the Medical University of Vienna via the Vienna General Hospital. Laboratory testing was supported by the Medical-Scientific fund of the mayor of the federal capital Vienna to JHA (grant Covid003).Otherwise, there was no specific funding or grant for this research from any funding agency in the public, commercial or not-for-profit sectors. The funders had no role in considering the study design or in the collection, analysis, or interpretation of data, the writing of the report, or the decision to submit the article for publication.
Competing interests DM reports support for meeting attendances from Pfizer. AK reports about contracts and personal fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Merck Sharp and Dohme. PM reports speaker fees from AbbVie, Janssen and Novartis and research grants from AbbVie, BMS, Novartis, Janssen, MSD and UCB. JSS reports about grants, consulting and personal fees from AbbVie, Astra-Zeneca, Lilly, Novartis, Amgen, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung and UCB. AH reports fees from MDGH. HH received grants from Glock Health, BlueSky Immunotherapies and Neutrolis. DA received grants and consulting fees from AbbVie, Amgen, Lilly, Merck, Novartis, Pfizer, Roche and Sandoz. MB reports about personal fees from Eli-Lilly. All other authors declare no competing interests.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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