Evidence map›Paper›PMID 35503375›Full record

ArticleJournal of neurology2022

Difference in safety and humoral response to mRNA SARS-CoV-2 vaccines in patients with autoimmune neurological disorders: the ANCOVAX study.

Maria Pia Giannoccaro, Veria Vacchiano, Marta Leone, Federico Camilli, Corrado Zenesini, Ivan Panzera, Alice Balboni, Maria Tappatà, Annamaria Borghi, Fabrizio Salvi and 7 more

Open access · bronzeAbstract read
In one paragraph

Article in Journal of neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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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

17 authors at 3 institutions in 1 country.

Maria Pia GiannoccaroDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy. mpgiannoccaro@gmail.com.ORCID http://orcid.org/0000-0003-2208-376X
Veria VacchianoDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.
Marta LeoneMicrobiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Federico CamilliDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.
Corrado ZenesiniIRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, 40139, Bologna, Italy.
Ivan PanzeraDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.
Alice BalboniMicrobiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Maria TappatàIRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, 40139, Bologna, Italy.
Annamaria BorghiIRCCS Istituto delle Scienze Neurologiche di Bologna, Neurology and Metropolitan Stroke Center, "C.A. Pizzardi" Maggiore Hospital, Bologna, Italy.
Fabrizio SalviIRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, 40139, Bologna, Italy.
Alessandra LugaresiDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.
Rita RinaldiIRCCS Istituto delle Scienze Neurologiche di Bologna, UOC Interaziendale Metropolitana (NeuroMet), - Neurologia AOU S.Orsola-Malpighi, Bologna, Italy.
Giulia Di FeliceDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Vittorio LodiOccupational Health Unit, Istituto di Ricovero e Cura a Carattere Scientifico St. Orsola Polyclinic, University of Bologna, Bologna, Italy.
Tiziana Lazzarotto *Microbiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Rocco Liguori *Dipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italy.
ANCOVAX study group
Istituto delle Scienze Neurologiche di Bologna · ITUniversity of Bologna · ITAzienda USL di Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAssessing the safety of SARS-CoV-2 mRNA vaccines and the effect of immunotherapies on the seroconversion rate in patients with autoimmune neurological conditions (ANC) is relevant to clinical practice. Our aim was to assess the antibody response to and safety of SARS-CoV-2 mRNA vaccines in ANC.

methodsThis longitudinal study included ANC patients vaccinated with two doses of BNT162b2 or mRNA-1273 between March and August 2021. Side effects were assessed 2-10 days after each dose. Neurological status and anti-spike receptor binding domain antibody levels were evaluated before vaccination and 4 weeks after the second dose. Healthcare-workers served as controls for antibody levels.

resultsWe included 300 ANC patients (median age 52, IQR 40-65), and 347 healthcare-workers (median age 45, IQR 34-54). mRNA-1273 vaccine was associated with an increased risk of both local (OR 2.52 95% CI 1.45-4.39, p = 0.001) and systemic reactions (OR 2.51% CI 1.49-4.23, p = 0.001). The incidence of relapse was not different before and after vaccine (Incidence rate ratio 0.72, 95% CI 0.29-1.83). Anti-SARS-CoV-2 IgG were detected in 268 (89.9%) patients and in all controls (p < 0.0001). BNT162b2 vaccine (OR 8.84 95% CI 2.32-33.65, p = 0.001), anti-CD20 mAb (OR 0.004 95% CI 0.0007-0.026, p < 0.0001) and fingolimod (OR 0.036 95% CI 0.002-0.628, p = 0·023) were associated with an increased risk of not developing anti-SARS-CoV-2 IgG.

conclusionSARS-CoV-2 mRNA vaccines were safe in a large group of ANC patients. Anti-CD20 and fingolimod treatment, as well as vaccination with the BNT162b2 vaccine, led to a reduced humoral response. These findings could inform vaccine policies in ANC patients undergoing immunotherapy.

Indexed as

Autoimmune Diseases of the Nervous SystemCOVID-19COVID-19 VaccinesImmunity, Humoral2019-nCoV Vaccine mRNA-1273AdultAgedAntibodies, ViralBNT162 VaccineFingolimod HydrochlorideHumansImmunoglobulin GLongitudinal StudiesMiddle AgedSARS-CoV-22019-nCoV Vaccine mRNA-1273Antibodies, ViralBNT162 VaccineCOVID-19 VaccinesFingolimod HydrochlorideImmunoglobulin GAutoimmune neurological disordersHumoral responseImmune therapyMultiple sclerosisSars-Cov2-mRNA vaccine

Identifiers

PMID35503375
PMCPMC9063626
OpenAlexW4225314973

What OpenQuestion holds

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Registered trials

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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.