Observatory of the Efficacy and Safety of Vaccination Against SARS-CoV-2 in Neuromuscular Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,388
- 试验地点
- 1
- 主要终点
- the frequency of serious adverse reactions (SAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with one of the following neuromuscular diseases:
- •Autoimmune myasthenia gravis, Lambert-Eaton syndrome
- •Congenital myasthenic syndromes
- •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
- •Patient over 18 years old
- •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
- •Patients having been informed of the study and having expressed their agreement
排除标准
- •Patient under legal protection, curatorship or tutorship
结局指标
主要结局
the frequency of serious adverse reactions (SAEs)
时间窗: at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
the frequency of serious adverse reactions (SAEs) in the population of neuromuscular patients vaccinated against COVID19 Serious adverse reaction or event (Article R1123-46 of the Public Health Code and ICH-E2B guideline) Any adverse reaction or event that: * results in death, * endangers the life of the participant, * requires hospitalisation or prolongation of hospitalisation, * causes an inability or significant or long-term disability, * results in an abnormality or congenital malformation, * or any event considered to be medically serious, and with respect to the drug, regardless of the dose administered. The expression "life-threatening" is reserved for an immediate life threat at the time of the adverse event.
the frequency of unexpected adverse reactions (SUSARs)
时间窗: at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).
Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator's brochure or is not listed at the specificity or severity that has been observed; or, if an investigator's brochure is not required or available, is not consistent with the risk information
次要结局
- the frequency of serious adverse reactions (SAEs) at 5 months(at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- vaccination's global safety : Frequency of Adverse Effects (AEs)(at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- Risk of worsening autoimmune myasthenia gravis after vaccination(at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- Frequency of hospitalizations for myasthenic crisis(at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- effectiveness of the vaccination(at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of serious adverse reactions (SAEs) at 3 months(at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- Frequency of worsening of the autonomy of the patients evaluated with the MG-ADL(at 1 month after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of serious adverse reactions (SAEs) at 2 months(at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of serious adverse reactions (SAEs) at 4 months(at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of serious adverse reactions (SAEs) at 6 months(at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of unexpected adverse reactions (SUSARs) at 2 months(at 2 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of unexpected adverse reactions (SUSARs) at 3 months(at 3 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of unexepected adverse reactions (SUSARs) at 5 months(at 5 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of unexpected adverse reactions (SUSARs) at 4 months(at 4 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)
- the frequency of unexpected adverse reactions (SUSARs) at 6 months(at 6 months after the end of the vaccination against SARS-CoV-2 (after the 2nd injection for the majority of vaccines).)