Efficacy and Safety of Vaccination Against COVID-19 in Neuromuscular Patients

NCT ID: NCT05311904

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1388 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2023-02-03

Brief Summary

The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and in severe cases and long hospital stays, the disability of some neuromuscular patients may worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as myasthenia gravis can worsen after an infection such as COVID-19.

Thanks to an unprecedented research effort, vaccines are now available and others still in development. The first studies published in medical journals are reassuring about the efficacy and safety of these vaccines. However, they have been studied in the general population and we do not yet have specific information in neuromuscular patients.

This is the reason why the Va-C-NEMUS observatory was launched.

Detailed Description

Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is eagerly awaited by patients and their healthcare teams. An unprecedented research effort has made it possible to create vaccines in a very short time when no vaccine directed against a coronavirus has existed until now. Some of these vaccines are based on proven technologies while others such as RNA vaccines are very innovative. The results of the phase III studies of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the European Medicines Agency. The data on the individuals enrolled in these trials are still not very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data from 4 different trials. In two of them the patients had to be in "good health". In any case, we do not know the pathologies presented by patients outside the usual risk factors for the severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No data on neuromuscular patients are currently known. The vaccination campaign began in France in January 2021. The first neuromuscular patients should be vaccinated soon depending on their comorbidities, but many questions arise in these patients both in terms of safety and efficacy.

Conditions

Neuromuscular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Survey

1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient with one of the following neuromuscular diseases:

• Autoimmune myasthenia gravis, Lambert-Eaton syndrome
• Congenital myasthenic syndromes
• Myositis
• Inflammatory neuropathies
• Hereditary neuropathies (Charcot-Marie-Tooth disease, etc.)
• Amyloid neuropathies
• Spinal atrophies
• Myotonic dystrophies type 1 (Steinert disease) and 2 (PROMM)
• Duchenne and Becker muscular dystrophies
• Muscular dystrophies of the girdles
• Pump disease
• Congenital myopathies
• Congenital muscular dystrophies
• Metabolic myopathies
• Other myopathies with confirmed genetic diagnosis

2. Patient over 18 years old

3. Patient having understood that the follow-up of a possible side effect of the vaccination or of a COVID-19 must be carried out by his usual doctor (s) and not by the observatory team Va-C-NEMUS

4. Patients having been informed of the study and having expressed their agreement

Exclusion Criteria

1. Patient under legal protection, curatorship or tutorship

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guilhem SOLE, MD

Role: PRINCIPAL_INVESTIGATOR

Université Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2020/68

Identifier Type: -

Identifier Source: org_study_id