COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series
Objective To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease.Methods We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatm...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-10-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/9/4/e003400.full |
| _version_ | 1797366718498078720 |
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| author | Emmanouil Rampakakis Paul R Fortin Sasha Bernatsky Louis Bessette Ines Colmegna Elizabeth Hazel Laëtitia Michou Mary-Ann Fitzcharles Louis Flamand Emmanuelle Rollet-Labelle Marc-André Langlois Valeria Valerio Nathalie Amiable Mariana Useche Deirdre McCormack Pantelis Panopalis |
| author_facet | Emmanouil Rampakakis Paul R Fortin Sasha Bernatsky Louis Bessette Ines Colmegna Elizabeth Hazel Laëtitia Michou Mary-Ann Fitzcharles Louis Flamand Emmanuelle Rollet-Labelle Marc-André Langlois Valeria Valerio Nathalie Amiable Mariana Useche Deirdre McCormack Pantelis Panopalis |
| author_sort | Emmanouil Rampakakis |
| collection | DOAJ |
| description | Objective To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease.Methods We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatment; systemic lupus erythematosus (SLE, n=23) on mycophenolate mofetil (MMF); other rheumatic diseases on prednisone ≥10 mg/day (n=8) or age-matched/sex-matched controls (healthy control, HC, n=58). Adverse events (AEs), humoral immune responses (immunogenicity: IgG positivity for anti-SARS-CoV-2 spike protein and its receptor binding domain, neutralising antibodies (NAbs)), cellular responses (ELISpot) and COVID-19 infection rates were assessed.Results Frequency of solicited self-reported AEs following vaccination was similar across groups (HC 90%, RA 86%, SLE 90%); among them, musculoskeletal AEs were more frequent in RA (HC 48% vs RA 66% (Δ95% CI CI 3 to 32.6)). Disease activity scores did not increase postvaccination. No vaccine-related serious AEs were reported. Postvaccination immunogenicity was reduced in RA and SLE (RA 90.2%, SLE 86.4%; for both, ΔCIs compared with HC excluded the null). Similarly, NAbs were reduced among patients (RA 82.6%, SLE 81.8%). In RA, age >65 (OR 0.3, 95% CI 0.1 to 0.8) and rituximab treatment (OR 0.003, 95% CI 0.001 to 0.02) were negative predictors of immunogenicity. ELISpot was positive in 16/52 tested RA and 17/26 HC (ΔCI 11.2–53.3). During the study, 11 HC, 19 RA and 3 SLE patients self-reported COVID-infection.Conclusion In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe. MMF, RA age >65 and rituximab were associated with reduced vaccine-induced protection. |
| first_indexed | 2024-03-08T17:07:38Z |
| format | Article |
| id | doaj.art-415d65e64f6946bca59bbd53b7d84efa |
| institution | Directory Open Access Journal |
| issn | 2056-5933 |
| language | English |
| last_indexed | 2024-03-08T17:07:38Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | RMD Open |
| spelling | doaj.art-415d65e64f6946bca59bbd53b7d84efa2024-01-04T04:20:07ZengBMJ Publishing GroupRMD Open2056-59332023-10-019410.1136/rmdopen-2023-003400COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary seriesEmmanouil Rampakakis0Paul R Fortin1Sasha Bernatsky2Louis Bessette3Ines Colmegna4Elizabeth Hazel5Laëtitia Michou6Mary-Ann Fitzcharles7Louis Flamand8Emmanuelle Rollet-Labelle9Marc-André Langlois10Valeria Valerio11Nathalie Amiable12Mariana Useche13Deirdre McCormack14Pantelis Panopalis15McGill University Health Centre, Montreal, Quebec, CanadaCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, CanadaClinical Epidemiology, Research Institute of the McGill University Health Centre, Montreal, Quebec, CanadaCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, CanadaResearch Institute of the McGill University Health Centre, Montreal, Quebec, CanadaDepartment of Medicine, McGill University Health Centre, Montreal, Quebec, CanadaCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, CanadaDepartment of Medicine, McGill University Health Centre, Montreal, Quebec, CanadaCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, CanadaCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, CanadaDepartment of Biochemistry Microbiology and Immunology, University of Ottawa, Ottawa, Ontario, CanadaResearch Institute of the McGill University Health Centre, Montreal, Quebec, CanadaCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, CanadaDepartment of Family Medicine, McGill University, Montreal, Quebec, CanadaMcGill University Health Centre, Montreal, Quebec, CanadaDepartment of Medicine, McGill University Health Centre, Montreal, Quebec, CanadaObjective To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease.Methods We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatment; systemic lupus erythematosus (SLE, n=23) on mycophenolate mofetil (MMF); other rheumatic diseases on prednisone ≥10 mg/day (n=8) or age-matched/sex-matched controls (healthy control, HC, n=58). Adverse events (AEs), humoral immune responses (immunogenicity: IgG positivity for anti-SARS-CoV-2 spike protein and its receptor binding domain, neutralising antibodies (NAbs)), cellular responses (ELISpot) and COVID-19 infection rates were assessed.Results Frequency of solicited self-reported AEs following vaccination was similar across groups (HC 90%, RA 86%, SLE 90%); among them, musculoskeletal AEs were more frequent in RA (HC 48% vs RA 66% (Δ95% CI CI 3 to 32.6)). Disease activity scores did not increase postvaccination. No vaccine-related serious AEs were reported. Postvaccination immunogenicity was reduced in RA and SLE (RA 90.2%, SLE 86.4%; for both, ΔCIs compared with HC excluded the null). Similarly, NAbs were reduced among patients (RA 82.6%, SLE 81.8%). In RA, age >65 (OR 0.3, 95% CI 0.1 to 0.8) and rituximab treatment (OR 0.003, 95% CI 0.001 to 0.02) were negative predictors of immunogenicity. ELISpot was positive in 16/52 tested RA and 17/26 HC (ΔCI 11.2–53.3). During the study, 11 HC, 19 RA and 3 SLE patients self-reported COVID-infection.Conclusion In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe. MMF, RA age >65 and rituximab were associated with reduced vaccine-induced protection.https://rmdopen.bmj.com/content/9/4/e003400.full |
| spellingShingle | Emmanouil Rampakakis Paul R Fortin Sasha Bernatsky Louis Bessette Ines Colmegna Elizabeth Hazel Laëtitia Michou Mary-Ann Fitzcharles Louis Flamand Emmanuelle Rollet-Labelle Marc-André Langlois Valeria Valerio Nathalie Amiable Mariana Useche Deirdre McCormack Pantelis Panopalis COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series RMD Open |
| title | COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series |
| title_full | COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series |
| title_fullStr | COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series |
| title_full_unstemmed | COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series |
| title_short | COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series |
| title_sort | covid 19 vaccine in immunosuppressed adults with autoimmune rheumatic diseases coviaad safety immunogenicity and antibody persistence at 12 months following moderna spikevax primary series |
| url | https://rmdopen.bmj.com/content/9/4/e003400.full |
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