Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)

Background: Evidence on SARS-CoV-2 mRNA vaccination under siponimod treatment is rare. Methods: AMA-VACC is a prospective, open-label clinical study on SARS-CoV-2 mRNA vaccination during ongoing siponimod treatment (cohort 1), during siponimod interruption (cohort 2), or during treatment with other...

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Main Authors: Tjalf Ziemssen, Marie Groth, Veronika Eva Winkelmann, Tobias Bopp
Format: Article
Language:English
Published: MDPI AG 2023-08-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/11/8/1374
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author Tjalf Ziemssen
Marie Groth
Veronika Eva Winkelmann
Tobias Bopp
author_facet Tjalf Ziemssen
Marie Groth
Veronika Eva Winkelmann
Tobias Bopp
author_sort Tjalf Ziemssen
collection DOAJ
description Background: Evidence on SARS-CoV-2 mRNA vaccination under siponimod treatment is rare. Methods: AMA-VACC is a prospective, open-label clinical study on SARS-CoV-2 mRNA vaccination during ongoing siponimod treatment (cohort 1), during siponimod interruption (cohort 2), or during treatment with other disease-modifying therapies or without therapy (cohort 3). SARS-CoV-2-specific antibodies and T-cell reactivity were measured six months after the initial vaccination and one month after the booster. Results: 41 patients were recruited into cohort 1 (<i>n</i> = 17), cohort 2 (<i>n</i> = 4), and cohort 3 (<i>n</i> = 20). Seroconversion for SARS-CoV-2 neutralizing antibodies was reached by 50.0%, 100.0%, and 90.0% of patients at month 6 and by 81.3%, 100.0%, and 100.0% one month after booster (cohorts 1, 2, and 3, respectively). Antibody levels in cohort 1 increased after the booster compared to month 6 but remained lower compared to cohorts 2 and 3. T-cell responses were seen in 28.5%, 25.0%, and 73.7% at month 6 and in 28.6%, 50.0%, and 83.3% after the booster (cohorts 1, 2, and 3, respectively). In cohort 1, the extent of T-cell response was lower at month 6 compared to cohorts 2 and 3 but reached almost similar levels after the booster. Conclusions: The antibody and T-cell responses support SARS-CoV-2 (booster) vaccines in siponimod-treated patients.
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spelling doaj.art-94ac80569d1548598bd16d4ac61136452024-10-21T16:29:49ZengMDPI AGVaccines2076-393X2023-08-01118137410.3390/vaccines11081374Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)Tjalf Ziemssen0Marie Groth1Veronika Eva Winkelmann2Tobias Bopp3Department of Neurology, Center of Clinical Neuroscience, Carl Gustav Carus University Clinic, University Hospital of Dresden, Technische Universität Dresden, 01307 Dresden, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyInstitute for Immunology, University Medical Center of the Johannes Gutenberg University, 55131 Mainz, GermanyBackground: Evidence on SARS-CoV-2 mRNA vaccination under siponimod treatment is rare. Methods: AMA-VACC is a prospective, open-label clinical study on SARS-CoV-2 mRNA vaccination during ongoing siponimod treatment (cohort 1), during siponimod interruption (cohort 2), or during treatment with other disease-modifying therapies or without therapy (cohort 3). SARS-CoV-2-specific antibodies and T-cell reactivity were measured six months after the initial vaccination and one month after the booster. Results: 41 patients were recruited into cohort 1 (<i>n</i> = 17), cohort 2 (<i>n</i> = 4), and cohort 3 (<i>n</i> = 20). Seroconversion for SARS-CoV-2 neutralizing antibodies was reached by 50.0%, 100.0%, and 90.0% of patients at month 6 and by 81.3%, 100.0%, and 100.0% one month after booster (cohorts 1, 2, and 3, respectively). Antibody levels in cohort 1 increased after the booster compared to month 6 but remained lower compared to cohorts 2 and 3. T-cell responses were seen in 28.5%, 25.0%, and 73.7% at month 6 and in 28.6%, 50.0%, and 83.3% after the booster (cohorts 1, 2, and 3, respectively). In cohort 1, the extent of T-cell response was lower at month 6 compared to cohorts 2 and 3 but reached almost similar levels after the booster. Conclusions: The antibody and T-cell responses support SARS-CoV-2 (booster) vaccines in siponimod-treated patients.https://www.mdpi.com/2076-393X/11/8/1374COVID-19 vaccinationsecondary progressive multiple sclerosisdisease-modifying therapyneutralizing antibodiesT-cell response
spellingShingle Tjalf Ziemssen
Marie Groth
Veronika Eva Winkelmann
Tobias Bopp
Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)
Vaccines
COVID-19 vaccination
secondary progressive multiple sclerosis
disease-modifying therapy
neutralizing antibodies
T-cell response
title Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)
title_full Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)
title_fullStr Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)
title_full_unstemmed Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)
title_short Immune Response to Initial and Booster SARS-CoV-2 mRNA Vaccination in Patients Treated with Siponimod—Final Analysis of a Nonrandomized Controlled Clinical Trial (AMA-VACC)
title_sort immune response to initial and booster sars cov 2 mrna vaccination in patients treated with siponimod final analysis of a nonrandomized controlled clinical trial ama vacc
topic COVID-19 vaccination
secondary progressive multiple sclerosis
disease-modifying therapy
neutralizing antibodies
T-cell response
url https://www.mdpi.com/2076-393X/11/8/1374
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