Session Type: Late-Breaking Abstract Session
Session Time: 10:45AM-11:00AM
Background/Purpose: Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2)-induced coronavirus disease 2019 (COVID-19) has led to exponentially rising mortality, particularly in immunosuppressed patients, who inadequately respond to conventional COVID-19 vaccination.
Methods: In this blinded randomized clinical trial we compare the efficacy and safety of an additional booster vaccination with a vector versus mRNA vaccine in non-seroconverted patients. We assigned 60 patients under rituximab treatment, who did not seroconvert after their primary mRNA vaccination with either BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna), to receive a third dose, either using the same mRNA or the vector vaccine ChAdOx1 nCoV-19 (Oxford-AstraZeneca). Patients were stratified according to the presence of peripheral B-cells. The primary efficacy endpoint was the difference in the SARS-CoV-2 antibody seroconversion rate between vector (heterologous) and mRNA (homologous) vaccinated patients by week four. Key secondary endpoints included the overall seroconversion and cellular immune response; safety was assessed at weeks one and four.
Results: Seroconversion rates at week four were comparable between vector (6/27 patients, 22%) and mRNA (9/28, 32%) vaccine (p=0.6). Overall, 27% of patients seroconverted; specific T-cell responses were observed in 20/20 (100%) vector versus 13/16 (81%) mRNA vaccinated patients. Newly induced humoral and/or cellular responses occurred in 9/11 (82%) patients. No serious adverse events, related to immunization, were observed.
Conclusion: This enhanced humoral and/or cellular immune response supports an additional booster vaccination in non-seroconverted patients irrespective of a heterologous or homologous vaccination regimen.
To cite this abstract in AMA style:Bonelli M, Mrak D, Tobudic S, sieghart D, Mandl P, kornek b, simader e, Koblischke M, Radner H, perkmann t, haslacher h, Mayer M, hofer p, Redlich K, Husar-Memmer E, Fritsch-Stork R, Thalhammer R, Stiasny K, Winkler S, Smolen J, Aberle J, Zeitlinger M, Heinz L, Aletaha D. Additional Heterologous versus Homologous Booster Vaccination in Immunosuppressed Patients Without SARS-CoV-2 Antibody Seroconversion After Primary mRNA Vaccination: A Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/additional-heterologous-versus-homologous-booster-vaccination-in-immunosuppressed-patients-without-sars-cov-2-antibody-seroconversion-after-primary-mrna-vaccination-a-randomized-controlled-trial/. Accessed January 18, 2022.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/additional-heterologous-versus-homologous-booster-vaccination-in-immunosuppressed-patients-without-sars-cov-2-antibody-seroconversion-after-primary-mrna-vaccination-a-randomized-controlled-trial/