ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: L17

Additional Heterologous versus Homologous Booster Vaccination in Immunosuppressed Patients Without SARS-CoV-2 Antibody Seroconversion After Primary mRNA Vaccination: A Randomized Controlled Trial

Michael Bonelli1, Daniel Mrak1, Selma Tobudic1, Daniela sieghart1, Peter Mandl1, barbara kornek1, elisabeth simader1, Maximilian Koblischke1, Helga Radner1, thomas perkmann1, helmuth haslacher1, Margareta Mayer1, philipp hofer1, Kurt Redlich2, Emma Husar-Memmer3, Ruth Fritsch-Stork4, Renate Thalhammer1, Karin Stiasny1, Stefan Winkler1, Josef Smolen1, Judith Aberle1, Markus Zeitlinger1, Leonhard Heinz1 and Daniel Aletaha5, 1Medical University of Vienna, Vienna, Austria, 2Hietzing Hospital, Vienna, Austria, 3Hanusch Hospital, Vienna, Austria, 4Sigmund Freud University, Utrecht, Netherlands, 5Medical University Vienna, Wien, Austria

Meeting: ACR Convergence 2021

Date of first publication: October 22, 2021

Keywords: , ,

Session Information

Date: Tuesday, November 9, 2021

Title: Late-Breaking Abstracts (L16 - L21)

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.

M. Bonelli, EliLilly, 2; D. Mrak, None; S. Tobudic, None; D. sieghart, None; P. Mandl, AbbVie, 5, 6, Janssen, 5, 6, Novartis, 5, 6, BMS, 5, MSD, 5, UCB, 5; b. kornek, Biogen, 2, 6, BMS Celgene, 2, 6, Johnsson&Johnsson, 2, 6, Merck, 2, 6, Novartis, 2, 6, Roche, 2, 6, Sanofi-Genzyme, 2, 6, Teva, 2, 6; e. simader, None; M. Koblischke, None; H. Radner, None; t. perkmann, None; h. haslacher, Glock Health, 5, BlueSky Immunotherapies, 5, Neutrolis, 5; M. Mayer, None; p. hofer, None; K. Redlich, None; E. Husar-Memmer, None; R. Fritsch-Stork, None; R. Thalhammer, None; K. Stiasny, Pfizer, 5; S. Winkler, None; J. Smolen, AbbVie, 2, 5, Astra-Zeneca, 2, 5, Lilly, 2, 5, Novartis, 2, 5, Amgen, 2, 5, Astro, 2, 5, BMS, 2, 5, Celgene, 2, 5, Celltrion, 2, 5, Chugai, 2, 5, Gilead, 2, 5, ILTOO, 2, 5, Janssen, 2, 5, MSD, 2, 5, Novartis-Sandoz, 2, 5, Pfizer, 2, 5, Roche, 2, 5, Samsung, 2, 5, UCB, 2, 5; J. Aberle, None; M. Zeitlinger, Nabriva, 2, 5, AntibioTxApS, 2, 5, Shionogi, 2, 5, NovoNordisk, 2, 5, Merck, 2, 5, Infectopharm, 2, 5, Pfizer, 2, 5; L. Heinz, None; D. Aletaha, AbbVie, 2, 5, Amgen, 2, 5, Lilly, 2, 5, Merck, 2, 5, Novartis-Sandoz, 2, 5, Pfizer, 2, 5, Roche, 2, 5.

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 9). 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 .

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