Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy

NCT05353738 | Completed

• 1 other identifier: CHUBX 2021/13
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Des vaccins sont désormais disponibles en France, dont le vaccin Moderna COVID-19 qui est basé sur la technologie des ARNm. La séquence génétique qu'il contient code pour la protéine Spike (S) de l'enveloppe virale, protéine clé de la pénétration du virus dans les cellules qu'il infecte. Le vaccin ARNm est injecté par voie intramusculaire et pénètre dans les fibres musculaires, qui sont des cellules produisant des protéines en très grande quantité en continu, notamment pour la production de myofibrilles impliquées dans la contraction musculaire. Une fois à l'intérieur de la fibre musculaire, l'ARNm vaccinal est traduit par la machinerie de la fibre musculaire permettant une grande quantité de protéine Spike (S) qui sera présentée au système immunitaire provoquant la réponse vaccinale et notamment les anticorps neutralisants anti-S (NAb). Ces NAb anti-S agissent en perturbant l'interaction entre la protéine S du virus et le récepteur ACE2 (Angiotensin-Converting Enzyme 2), qui sert généralement de " passerelle " entre le virus et la cellule. Une campagne de vaccination est actuellement en cours au MAS-YDK avec le vaccin Moderna. Cette population est donc relativement homogène en termes d'amyotrophie, de non exposition au SARS-CoV-2 et de protocole vaccinal.

Conditions

Neuromuscular Diseases; COVID-19; Amyotrophy

Keywords

neuromuscular; Amyotrophy; mRNA vaccines; COVID-19; protein neutralization; S infection; vaccine Moderna

Outcome Measures

Primary Outcomes (1)

• Look for the presence of antibodies anti-Spike neutralizers, 6 weeks after the second injection of the vaccine Moderna against COVID-19 in patients with severe amyotrophy in MAS Yolaine de Kepper.

  The presence of Ac causing the neutralization of the interaction between the viral protein S and the receptor ACE-2 cells by the syncytia formation inhibition assay.

  6 weeks after the second injection of the Moderna vaccine

Secondary Outcomes (7)

• Confirm the presence of anti-Spike neutralizing antibodies, 6 weeks after the second injection of the Moderna vaccine against COVID-19 by another technique:

  6 week after the second injection of Moderna vaccine

• Look for the presence of anti-Spike neutralizing antibodies, 24 weeks after the second injection of the Moderna vaccine against COVID-19

  24 week after the second injection of the Moderna vaccine against

• Look for the presence of neutralizing antibodies to Spike, 52 or 64 weeks after the second injection of the Moderna vaccine against COVID-19 (i.e. approximately 6 months or 9 months after the 3rd dose of reminder)

  52 or 64 week after the second injection of the Moderna vaccine

• Look for the presence of neutralizing antibodies directed against most recent delta and omicron variants, at all times of study

  Throughout study completion, an average 64 week

• Assessing the effectiveness of vaccination in real life

  Throughout study completion, an average 64 week

Study Arms (3)

Patients with severe neuromuscular disease

Patient with severe neuromuscular disease and having received vaccination with the Moderna vaccine

Biological: Blood sample for research of anti-xoprs netralizing anti spike; Other: Questionnaire

Patients groupe témoins négatif

Patient having had a blood sample taken as part of the treatment for virological analysis before anti-COVID 19 vaccination

Biological: Blood sample for research of anti-xoprs netralizing anti spike

Patients groupe témoins positif

Patient having had a blood sample taken as part of the treatment for virological analysis following infection with the omicron variant.

Biological: Blood sample for research of anti-xoprs netralizing anti spike

Interventions

Blood sample for research of anti-xoprs netralizing anti spike BIOLOGICAL

The evaluation of the ex vivo efficacy of the Moderna vaccine by the search for anti Spike AcN at 6,24, 40 and 52 or 64 weeks after the second injection of the vaccine. The effectiveness of vaccination of CANNEMUSS patients will be evaluated by comparing the antibodies anti-S neutralizers from patients in the CANNEMUSS study to those from patients whose sample was carried out before the pandemic (negative control group) and those of patients infected with the omicron virus (positive control group).

Patients groupe témoins négatif; Patients groupe témoins positif; Patients with severe neuromuscular disease

Questionnaire OTHER

Evaluation of vaccine efficacy in real life by filling out questionnaires

Patients with severe neuromuscular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe neuromuscular disease and patient (groupe temoins) having had a blood sample taken as part of the treatment for virological analysis

You may qualify if:

• \- For patients with severe neuromuscular disease:
• Adult over 18
• Person with a defined severe neuromuscular pathology by a modified Rankin score ≥ 4
• Person supported at the YDK pole
• Person who has received vaccination with the Moderna vaccine, in the quadriceps or deltoid
• Non-objection of the patient and/or his legal representative to the participation in the study
• For patients in the negative control group :
• Non-objection of the patient to the storage and use in the framework of the CANNEMUSS study of these blood samples from the routine care.
• Patient having had a blood sample taken as part of the treatment for virological analysis before anti-COVID 19 vaccination.
• Patient matched in sex and age to a patient included in the study CANNEMUSS.
• For patients in the positive control group :
• Non-objection of the patient to the storage and use in the framework of the CANNEMUSS study of these blood samples from the routine care.
• Patient having had a blood sample taken as part of the treatment for virological analysis following infection with the omicron variant.

You may not qualify if:

• Person with symptomatic infection with SARS-CoV-2 proven by a positive PCR
• Person with Amyotrophic Lateral Sclerosis

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux

Bordeaux, 33 000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample at 6 weeks (+/- 4 days) after the second injection of the Moderna vaccine, at 24 weeks (+/- 1 week), at 40 weeks (+/- 1 week) and at 52 or 64weeks (+/- 12 weeks) after the second injection

MeSH Terms

Conditions

Neuromuscular Diseases; COVID-19; Muscular Atrophy

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guilhem SOLE, Dr

  Université Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 29, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

FR (1)