Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis
Background: Few data exist on how ofatumumab treatment impacts SARS-CoV-2 booster vaccination response. Methods: KYRIOS is an ongoing prospective open-label multicenter study on the response to initial and booster SARS-CoV-2 mRNA vaccination before or during ofatumumab treatment in relapsing MS pati...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-05-01
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| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/11/5/978 |
| _version_ | 1797598176752959488 |
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| author | Tjalf Ziemssen Eugen Schlegel Marie Groth Benjamin Ettle Tobias Bopp |
| author_facet | Tjalf Ziemssen Eugen Schlegel Marie Groth Benjamin Ettle Tobias Bopp |
| author_sort | Tjalf Ziemssen |
| collection | DOAJ |
| description | Background: Few data exist on how ofatumumab treatment impacts SARS-CoV-2 booster vaccination response. Methods: KYRIOS is an ongoing prospective open-label multicenter study on the response to initial and booster SARS-CoV-2 mRNA vaccination before or during ofatumumab treatment in relapsing MS patients. The results on the initial vaccination cohort have been published previously. Here, we describe 23 patients who received their initial vaccination outside of the study but booster vaccination during the study. Additionally, we report the booster results of two patients in the initial vaccination cohort. The primary endpoint was SARS-CoV-2-specific T-cell response at month 1. Furthermore, serum total and neutralizing antibodies were measured. Results: The primary endpoint was reached by 87.5% of patients with booster before (booster cohort 1, N = 8) and 46.7% of patients with booster during ofatumumab treatment (booster cohort 2, N = 15). Seroconversion rates for neutralizing antibodies increased from 87.5% at baseline to 100.0% at month 1 in booster cohort 1 and from 71.4% to 93.3% in booster cohort 2. Of note, 3 of 4 initially seronegative patients in booster cohort 2 and one seronegative patient in the initial vaccination cohort seroconverted after the booster during ofatumumab treatment. Conclusions: Booster vaccinations increase neutralizing antibody titers in ofatumumab-treated patients. A booster is recommended in ofatumumab-treated patients. |
| first_indexed | 2024-03-11T03:15:40Z |
| format | Article |
| id | doaj.art-ac00cfb520a44e20918f9b265e5a4f73 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-11T03:15:40Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-ac00cfb520a44e20918f9b265e5a4f732023-11-18T03:36:35ZengMDPI AGVaccines2076-393X2023-05-0111597810.3390/vaccines11050978Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple SclerosisTjalf Ziemssen0Eugen Schlegel1Marie Groth2Benjamin Ettle3Tobias Bopp4Department of Neurology, Center of Clinical Neuroscience, Carl Gustav Carus University Clinic, University Hospital of Dresden, Technische Universität Dresden, 01062 Dresden, GermanyZentrum für Neurologische Studien, 57076 Siegen, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyInstitute for Immunology, University Medical Center, Johannes Gutenberg University, 55131 Mainz, GermanyBackground: Few data exist on how ofatumumab treatment impacts SARS-CoV-2 booster vaccination response. Methods: KYRIOS is an ongoing prospective open-label multicenter study on the response to initial and booster SARS-CoV-2 mRNA vaccination before or during ofatumumab treatment in relapsing MS patients. The results on the initial vaccination cohort have been published previously. Here, we describe 23 patients who received their initial vaccination outside of the study but booster vaccination during the study. Additionally, we report the booster results of two patients in the initial vaccination cohort. The primary endpoint was SARS-CoV-2-specific T-cell response at month 1. Furthermore, serum total and neutralizing antibodies were measured. Results: The primary endpoint was reached by 87.5% of patients with booster before (booster cohort 1, N = 8) and 46.7% of patients with booster during ofatumumab treatment (booster cohort 2, N = 15). Seroconversion rates for neutralizing antibodies increased from 87.5% at baseline to 100.0% at month 1 in booster cohort 1 and from 71.4% to 93.3% in booster cohort 2. Of note, 3 of 4 initially seronegative patients in booster cohort 2 and one seronegative patient in the initial vaccination cohort seroconverted after the booster during ofatumumab treatment. Conclusions: Booster vaccinations increase neutralizing antibody titers in ofatumumab-treated patients. A booster is recommended in ofatumumab-treated patients.https://www.mdpi.com/2076-393X/11/5/978COVID-19 vaccinationrelapsing multiple sclerosisofatumumabneutralizing antibodiesT-cell responses |
| spellingShingle | Tjalf Ziemssen Eugen Schlegel Marie Groth Benjamin Ettle Tobias Bopp Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis Vaccines COVID-19 vaccination relapsing multiple sclerosis ofatumumab neutralizing antibodies T-cell responses |
| title | Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis |
| title_full | Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis |
| title_fullStr | Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis |
| title_full_unstemmed | Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis |
| title_short | Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis |
| title_sort | results on sars cov 2 mrna vaccine booster from an open label multicenter study in ofatumumab treated participants with relapsing multiple sclerosis |
| topic | COVID-19 vaccination relapsing multiple sclerosis ofatumumab neutralizing antibodies T-cell responses |
| url | https://www.mdpi.com/2076-393X/11/5/978 |
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