Evidence map›Paper›PMID 38030231›Full record

Trial reportRMD open2023

COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series.

Ines Colmegna, Valeria Valerio, Nathalie Amiable, Mariana Useche, Emmanouil Rampakakis, Louis Flamand, Emmanuelle Rollet-Labelle, Louis Bessette, Mary-Ann Fitzcharles, Elizabeth Hazel and 6 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in RMD open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 13 citations in OpenAlex.

  1. Observational
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 1 country.

Ines ColmegnaResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada ines.colmegna@mcgill.ca.ORCID 0000-0002-8091-8334
Valeria ValerioResearch Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Nathalie AmiableCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada.
Mariana UsecheDepartment of Family Medicine, McGill University, Montreal, Quebec, Canada.
Emmanouil RampakakisMcGill University Health Centre, Montreal, Quebec, Canada.
Louis FlamandCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada.
Emmanuelle Rollet-LabelleCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada.
Louis BessetteCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada.
Mary-Ann FitzcharlesDepartment of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.
Elizabeth HazelDepartment of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.
Deirdre McCormackMcGill University Health Centre, Montreal, Quebec, Canada.
Laëtitia MichouCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada.
Pantelis PanopalisDepartment of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.
Marc-André LangloisDepartment of Biochemistry Microbiology and Immunology, University of Ottawa, Ottawa, Ontario, Canada.
Sasha BernatskyClinical Epidemiology, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.ORCID 0000-0002-9515-2802
Paul R FortinCentre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada.
McGill University Health Centre · CAUniversité Laval · CACentre hospitalier de l'Université Laval · CAMcGill University · CAUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease.

methodsWe 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.

resultsFrequency 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.

conclusionIn 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.

Indexed as

Autoimmune DiseasesCOVID-19Lupus Erythematosus, SystemicRheumatic Diseases2019-nCoV Vaccine mRNA-1273AdultCOVID-19 VaccinesHumansMycophenolic AcidProspective StudiesRituximab2019-nCoV Vaccine mRNA-1273COVID-19 VaccinesMycophenolic AcidRituximabCOVID-19Rheumatoid ArthritisSystemic Lupus ErythematosusVaccination

Identifiers

PMID38030231
PMCPMC10689388
OpenAlexW4389132258

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.