Neuromuscular DiseasesCANNEMUSSNCT05353738
Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
An observational study of Neuromuscular Diseases and COVID-19, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases, COVID-19, Amyotrophy
- What is being tested?
- Blood sample for research of anti-xoprs netralizing anti spike and Questionnaire
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- Exclusion Criteria for patients with neuromuscular disease severe
- Person with symptomatic infection with SARS-CoV-2 proven by a positive PCR
- Person with Amyotrophic Lateral Sclerosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Vaccination Against COVID-19 by Screening for Neutralizing Antibodies in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
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.
Read the detailed description
COVID-19 is linked to SARS-CoV-2, a new coronavirus that can lead to death. Some neuromuscular patientsare considered at risk for various reasons: cardiomyopathy or rhythm and/or conduction disorder, ventilator insufficiency, severe motor disability with the need for human support for daily activities. Neuromuscular patients with severe amyotrophy are therefore at very high risk of severe forms of COVID-19. A still unpublished study of the French neuromuscular network FILNEMUS showed that in neuromuscular patients the risk of admission to ICU was 21.2% and the lethality rate 9.1%, well above the values observed in the general population. The prevention of COVID-19 is therefore key. Until now, in the MAS-YDK an extremely strict health protocol has been enacted to protect the residents: outings allowed only for medical appointments, 7-day quarantine for any resident returning from outside, routine systematic PCR of patients and caregivers, prohibition of visits by outsiders... This very stringent protocol has been very effective since no resident has presented any symptomatic COVID-19 but this was achieved at the cost of social isolation. Vaccination of both residents and staff is therefore the best avenue of hope for a return to a more normal life. Will vaccines using the muscle cell machinery be effective in amyotrophic patients? Vaccines are now available in France, including the Moderna COVID-19 vaccine which is based on mRNA technology. The genetic sequence it contains encodes the Spike protein (S) of the virus envelope, a protein which is key to the virus's penetration into the cells that it infects. The mRNA vaccine is injected intramuscularly and penetrates muscle fibers, which are cells producing proteins in very large quantities continuously, especially for the production of myofibrils involved in muscle contraction. Once inside the muscle fiber, the vaccine mNRA is translated by the muscle fiber machinery allowing a large amount of Spike protein (S) that will be presented to the immune system causing the vaccine response and in particular anti-S neutralizing antibodies (NAb). These anti-S NAbs work by disrupting the interaction between the virus's S protein and the ACE2 receptor (Angiotensin-Converting Enzyme 2), which usually serves as the "gateway" between the virus and the cell. A vaccination campaign is currently underway at the MAS-YDK with the Moderna vaccine. This population is therefore relatively homogeneous in terms of amyotrophy, lack of exposure to SARS-CoV-2 and vaccine protocol.
- Conditions
- Neuromuscular Diseases, COVID-19, Amyotrophy
- Being tested
- Blood sample for research of anti-xoprs netralizing anti spike, Questionnaire
- Keywords
- neuromuscular, Amyotrophy, mRNA vaccines, COVID-19, protein neutralization, S infection, vaccine Moderna
- Medical subject headings
- Neuromuscular Diseases, COVID-19, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for research of anti-xoprs netralizing anti spikeBiological
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).
QuestionnaireOther
Evaluation of vaccine efficacy in real life by filling out questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe neuromuscular disease | Patient with severe neuromuscular disease and having received vaccination with the Moderna vaccine Receives: 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 Receives: 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. Receives: Biological: Blood sample for research of anti-xoprs netralizing anti spike |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
Neutralization of infection of target cells expressing ACE-2 by a lentivirus expressing protein Sexpressing the protein S
Measured: 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
Neutralization of the interaction between the viral protein S and the cell receptor ACE-2 by the formation inhibition test of syncytia.
Neutralization of the infection of target cells expressing ACE-2 by a lentivirus expressing protein S
Measured: 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)
Neutralization of the interaction between the viral protein S and the cell receptor ACE-2 by the formation inhibition test of syncytia.
Neutralization of the infection of target cells expressing ACE-2 by a lentivirus expressing the S protein.
Measured: 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
Neutralization of the interaction between the viral proteins S delta and omicron and the cellular receptor by inhibition test of variant-adapted syncytia formation
Measured: Throughout study completion, an average 64 week
Assessing the effectiveness of vaccination in real life
- Frequency of COVID-19 cases confirmed by a PCR test or an antigen test that occurred at least 7 days after the second injection of the Moderna vaccine according to the protocol of usual follow-up of SAM YDK
Measured: Throughout study completion, an average 64 week
Compare the level of anti-Spike neutralizing antibodies
Compare the level of anti-Spike neutralizing antibodies of patients with severe disuse atrophy of MAS Yolaine from Kepper to that of a group of patients matched in sex and agewhose sera date from before the pandemic and constitute non-neutralizing negative controls.
Measured: Throughout study completion, an average 64 week
Compare the neutralization techniques
Compare the neutralization techniques developed for MAS YDK patients to some patient sera recently hospitalized with omicron variant infection, such as positive controls for this variant.
Measured: Throughout study completion, an average 64 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guilhem SOLE, Dr, Principal investigator, Université Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353738
- Sponsor's protocol ID
- CHUBX 2021/13
- Acronym
- CANNEMUSS
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Vaccination Against COVID-19 by Screening for Neutralizing Antibodies in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
- ClinicalTrials.gov ID
- NCT05353738
- Acronym / sponsor ID
- CANNEMUSS / CHUBX 2021/13
- Conditions
- Neuromuscular Diseases, COVID-19, Amyotrophy
- Keywords
- neuromuscular, Amyotrophy, mRNA vaccines, COVID-19, protein neutralization, S infection, vaccine Moderna
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
COVID-19 is linked to SARS-CoV-2, a new coronavirus that can lead to death. Some neuromuscular patientsare considered at risk for various reasons: cardiomyopathy or rhythm and/or conduction disorder, ventilator insufficiency, severe motor disability with the need for human support for daily activities. Neuromuscular patients with severe amyotrophy are therefore at very high risk of severe forms of COVID-19. A still unpublished study of the French neuromuscular network FILNEMUS showed that in neuromuscular patients the risk of admission to ICU was 21.2% and the lethality rate 9.1%, well above the values observed in the general population. The prevention of COVID-19 is therefore key. Until now, in the MAS-YDK an extremely strict health protocol has been enacted to protect the residents: outings allowed only for medical appointments, 7-day quarantine for any resident returning from outside, routine systematic PCR of patients and caregivers, prohibition of visits by outsiders... This very stringent protocol has been very effective since no resident has presented any symptomatic COVID-19 but this was achieved at the cost of social isolation. Vaccination of both residents and staff is therefore the best avenue of hope for a return to a more normal life. Will vaccines using the muscle cell machinery be effective in amyotrophic patients? Vaccines are now available in France, including the Moderna COVID-19 vaccine which is based on mRNA technology. The genetic sequence it contains encodes the Spike protein (S) of the virus envelope, a protein which is key to the virus's penetration into the cells that it infects. The mRNA vaccine is injected intramuscularly and penetrates muscle fibers, which are cells producing proteins in very large quantities continuously, especially for the production of myofibrils involved in muscle contraction. Once inside the muscle fiber, the vaccine mNRA is translated by the muscle fiber machinery allowing a large amount of Spike protein (S) that will be presented to the immune system causing the vaccine response and in particular anti-S neutralizing antibodies (NAb). These anti-S NAbs work by disrupting the interaction between the virus's S protein and the ACE2 receptor (Angiotensin-Converting Enzyme 2), which usually serves as the "gateway" between the virus and the cell. A vaccination campaign is currently underway at the MAS-YDK with the Moderna vaccine. This population is therefore relatively homogeneous in terms of amyotrophy, lack of exposure to SARS-CoV-2 and vaccine protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with severe neuromuscular disease | – | Biological: Blood sample for research of anti-xoprs netralizing anti spike, Other: QuestionnairePatient with severe neuromuscular disease and having received vaccination with the Moderna vaccine |
| Patients groupe témoins négatif | – | Biological: Blood sample for research of anti-xoprs netralizing anti spikePatient having had a blood sample taken as part of the treatment for virological analysis before anti-COVID 19 vaccination |
| Patients groupe témoins positif | – | Biological: Blood sample for research of anti-xoprs netralizing anti spikePatient having had a blood sample taken as part of the treatment for virological analysis following infection with the omicron variant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample for research of anti-xoprs netralizing anti spikeThe 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). | Biological | Patients groupe témoins négatif, Patients groupe témoins positif, Patients with severe neuromuscular disease |
| QuestionnaireEvaluation of vaccine efficacy in real life by filling out questionnaires | Other | Patients with severe neuromuscular disease |
Primary outcome
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.
Time frame: 6 weeks after the second injection of the Moderna vaccine
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.
7 secondary outcomes
Confirm the presence of anti-Spike neutralizing antibodies, 6 weeks after the second injection of the Moderna vaccine against COVID-19 by another technique:
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Throughout study completion, an average 64 week
Assessing the effectiveness of vaccination in real life
Time frame: Throughout study completion, an average 64 week
Compare the level of anti-Spike neutralizing antibodies
Time frame: Throughout study completion, an average 64 week
Compare the neutralization techniques
Time frame: Throughout study completion, an average 64 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilhem SOLE, Dr principal investigator
Université Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and COVID-19, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 weeks after the second injection of the Moderna vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.