SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis
Abstract Objective To investigate the serologic response, predictors of response, and clinical outcomes associated with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis (RMS) from DAYBREAK. Metho...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-10-01
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| Series: | Annals of Clinical and Translational Neurology |
| Online Access: | https://doi.org/10.1002/acn3.51862 |
| _version_ | 1827792853011529728 |
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| author | Bruce A. C. Cree Rachel Maddux Amit Bar‐Or Hans‐Peter Hartung Amandeep Kaur Elizabeth Brown Yicong Li Yanhua Hu James K. Sheffield Diego Silva Sarah Harris |
| author_facet | Bruce A. C. Cree Rachel Maddux Amit Bar‐Or Hans‐Peter Hartung Amandeep Kaur Elizabeth Brown Yicong Li Yanhua Hu James K. Sheffield Diego Silva Sarah Harris |
| author_sort | Bruce A. C. Cree |
| collection | DOAJ |
| description | Abstract Objective To investigate the serologic response, predictors of response, and clinical outcomes associated with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis (RMS) from DAYBREAK. Methods DAYBREAK (ClinicalTrials.gov‐NCT02576717), an open‐label extension study of oral ozanimod 0.92 mg, enrolled participants aged 18–55 years with RMS who completed phase 1–3 ozanimod trials. Participants who were fully vaccinated against SARS‐CoV‐2 with mRNA or non‐mRNA vaccines, were unvaccinated, and/or had COVID‐19–related adverse events (AEs, with or without vaccination) and postvaccination serum samples were included (n = 288). Spike receptor binding domain (RBD) antibody levels (seroconversion: ≥0.8 U/mL) and serologic evidence of SARS‐CoV‐2 infection (nucleocapsid IgG: ≥1 U/mL) were assessed (Roche Elecsys/Cobas e411 platform). Results In fully vaccinated participants (n = 148), spike RBD antibody seroconversion occurred in 90% (n = 98/109) of those without serologic evidence of prior SARS‐CoV‐2 exposure (100% [n = 80/80] seroconversion after mRNA vaccination) and in 100% (n = 39/39) of participants with serologic evidence of viral exposure. mRNA vaccination predicted higher spike RBD antibody levels, whereas absolute lymphocyte count (ALC), age, body mass index, and sex did not. COVID‐19–related AEs were reported in 10% (n = 15/148) of fully vaccinated participants—all were nonserious and not severe; all participants recovered. Interpretation Most ozanimod‐treated participants with RMS mounted a serologic response to SARS‐CoV‐2 vaccination and infection, regardless of participant characteristics or ALC levels. In this analysis, all COVID‐19–related AEs post–full vaccination in participants taking ozanimod were nonserious and not severe. |
| first_indexed | 2024-03-11T18:09:08Z |
| format | Article |
| id | doaj.art-4a8aee4d3b7d474b98f18866748e3647 |
| institution | Directory Open Access Journal |
| issn | 2328-9503 |
| language | English |
| last_indexed | 2024-03-11T18:09:08Z |
| publishDate | 2023-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | Annals of Clinical and Translational Neurology |
| spelling | doaj.art-4a8aee4d3b7d474b98f18866748e36472023-10-16T20:02:29ZengWileyAnnals of Clinical and Translational Neurology2328-95032023-10-0110101725173710.1002/acn3.51862SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosisBruce A. C. Cree0Rachel Maddux1Amit Bar‐Or2Hans‐Peter Hartung3Amandeep Kaur4Elizabeth Brown5Yicong Li6Yanhua Hu7James K. Sheffield8Diego Silva9Sarah Harris10Department of Neurology Weill Institute for Neurosciences, University of California San Francisco San Francisco California USABristol Myers Squibb Princeton New Jersey USADepartment of Neurology, Center for Neuroinflammation, and Experimental Therapeutics, Perelman School of Medicine University of Pennsylvania Philadelphia Pennsylvania USADepartment of Neurology Medical Faculty, Heinrich‐Heine University Düsseldorf GermanyBristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USAAbstract Objective To investigate the serologic response, predictors of response, and clinical outcomes associated with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis (RMS) from DAYBREAK. Methods DAYBREAK (ClinicalTrials.gov‐NCT02576717), an open‐label extension study of oral ozanimod 0.92 mg, enrolled participants aged 18–55 years with RMS who completed phase 1–3 ozanimod trials. Participants who were fully vaccinated against SARS‐CoV‐2 with mRNA or non‐mRNA vaccines, were unvaccinated, and/or had COVID‐19–related adverse events (AEs, with or without vaccination) and postvaccination serum samples were included (n = 288). Spike receptor binding domain (RBD) antibody levels (seroconversion: ≥0.8 U/mL) and serologic evidence of SARS‐CoV‐2 infection (nucleocapsid IgG: ≥1 U/mL) were assessed (Roche Elecsys/Cobas e411 platform). Results In fully vaccinated participants (n = 148), spike RBD antibody seroconversion occurred in 90% (n = 98/109) of those without serologic evidence of prior SARS‐CoV‐2 exposure (100% [n = 80/80] seroconversion after mRNA vaccination) and in 100% (n = 39/39) of participants with serologic evidence of viral exposure. mRNA vaccination predicted higher spike RBD antibody levels, whereas absolute lymphocyte count (ALC), age, body mass index, and sex did not. COVID‐19–related AEs were reported in 10% (n = 15/148) of fully vaccinated participants—all were nonserious and not severe; all participants recovered. Interpretation Most ozanimod‐treated participants with RMS mounted a serologic response to SARS‐CoV‐2 vaccination and infection, regardless of participant characteristics or ALC levels. In this analysis, all COVID‐19–related AEs post–full vaccination in participants taking ozanimod were nonserious and not severe.https://doi.org/10.1002/acn3.51862 |
| spellingShingle | Bruce A. C. Cree Rachel Maddux Amit Bar‐Or Hans‐Peter Hartung Amandeep Kaur Elizabeth Brown Yicong Li Yanhua Hu James K. Sheffield Diego Silva Sarah Harris SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis Annals of Clinical and Translational Neurology |
| title | SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis |
| title_full | SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis |
| title_fullStr | SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis |
| title_full_unstemmed | SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis |
| title_short | SARS‐CoV‐2 vaccination and infection in ozanimod‐treated participants with relapsing multiple sclerosis |
| title_sort | sars cov 2 vaccination and infection in ozanimod treated participants with relapsing multiple sclerosis |
| url | https://doi.org/10.1002/acn3.51862 |
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