Trial reportEBioMedicine2018
Acetylcholine Receptor Antibody Titers and Clinical Course after Influenza Vaccination in Patients with Myasthenia Gravis: A Double-Blind Randomized Controlled Trial (ProPATIent-Trial).
Trial report in EBioMedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03884777 (Incidence and Risk of Influenza in Myasthenic Patients Hospitalized in Intensive Care), which is not on this map. Cited by 10 papers.
What it found
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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.
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.
Incidence and Risk of Influenza in Myasthenic Patients Hospitalized in Intensive Care
Who cites it
10 citing papers in PubMed, 20 citations in OpenAlex.
- Myasthenia gravis and community-acquired pneumonia: therapeutic challenges.Frontiers in pharmacology · 2025Review
- Safety and neutralization antibody levels of inactivated SARS-CoV-2 vaccine in adult patients with Myasthenia Gravis: a prospective observational cohort study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Observational
- An observational study on the safety of COVID-19 vaccination in patients with myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023Observational
- SARS-CoV-2 vaccination and new-onset myasthenia gravis: A report of 7 cases and review of the literature.Neuromuscular disorders : NMD · 2022Review
- Vaccines and myasthenia gravis: a comprehensive review and retrospective study of SARS-CoV-2 vaccination in a large cohort of myasthenic patients.Journal of neurology · 2022Review
- Safety of inactivated SARS-CoV-2 vaccines in myasthenia gravis: A survey-based study.Frontiers in immunology · 2022Article
- Myasthenia Gravis Presenting after Administration of the mRNA-1273 Vaccine.European journal of case reports in internal medicine · 2022Article
- COVID-19 Vaccination in Patients with Myasthenia Gravis: A Single-Center Case Series.Vaccines · 2021Article
- Vaccination and Seasonality as Risk Factors for Development of Meningoencephalitis of Unknown Origin in 172 Dogs.Journal of veterinary internal medicineArticle
- To Be or Not To Be Vaccinated: That Is a Question in Myasthenia Gravis.Frontiers in immunologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt is a continuous matter of discussion whether immune activation by vaccination in general and Influenza vaccination in particular increases the risk for clinical deterioration of autoimmune diseases. This prospective study investigated the serological and clinical course of autoimmune Myasthenia gravis (MG) after a seasonal influenza vaccination.
methodsThis randomized, placebo-controlled, double-blind study enrolled MG patients with antibodies against acetylcholine-receptors (AChR-ab). They were allocated to receive seasonal influenza vaccine or placebo. The primary endpoint was the relative change of AChR-ab-titer over 12weeks. A relative increase of 20% was set as non-inferiority margin. Secondary endpoints were clinical changes in the modified Quantitative Myasthenia Gravis Score (QMG), increase of anti-influenza-ELISA-antibodies, and changes of treatment. The study is registered with Clinicaltrialsregister.eu, EudraCT number 2006-004374-27.
findings62 patients were included. Mean±standard deviation (median) in the vaccine and placebo group were AChR-ab-titer changes of -6.0%±23.3% (-4.0%) and -2.8%±22.0% (-0.5%) and QMG score changes of -0.08±0.27 (0.17) and 0.11±0.31 (0.00), respectively. The difference between groups (Hodges-Lehmann estimate with 95% CI) was - for the AChR-ab-titer change 4·0% [-13.3%, 4.5%] (p=0.28 for testing a difference, p<0.0001 for testing non-inferiority) and for the QMG change 0·00 [-0.17, 0.00] (p=0.79 for testing a difference). The occurrence of 74 adverse events (AE) was comparable between groups. The most common AE was flu-like symptoms. One serious AE (hospitalisation following gastrointestinal haemorrhage) in the verum group was not related to the vaccine.
interpretationInfluenza vaccination in MG is safe. Uprating the potential risk of a severe course of MG exacerbation during influenza infection compared to the 95% CI differences for the endpoints, vaccination is principally indicated in this patient population.
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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.