AMA-VACC
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Siponimod
Sphingosine 1-phosphate receptor Edg-1 agonist
- Tozinameran
Spike glycoprotein vaccine antigen
- Elasomeran
Spike glycoprotein vaccine antigen
- COVID-19 mRNA Vaccine (nucleoside modified)
- COVID-19 mRNA vaccine (nucleoside-modified)
- COVID-19 Vaccine Janssen (Ad26.COV2.S)
- COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
Compared with
- Baseline disease modifying therapies (DMTs)
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
- Glatiramer acetate
Unknown
- Interferon beta-1b
Interferon alpha/beta receptor agonist
Results by group
Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS)
At 1 week after vaccination period (defined as 1 week after second dose of vaccine)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Siponimod - Continuous | 52.9 percentage of participants | 27.8–77 | 17 |
| Siponimod- Interrupted | 75.0 percentage of participants | 19.4–99.4 | 4 |
| DMT or no MS Treatment | 90.0 percentage of participants | 68.3–98.8 | 20 |
Siponimod - Continuous
Siponimod- Interrupted
DMT or no MS Treatment
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Siponimod Continuous | 17 | 1 (5.9%) | 0 |
| Siponimod Interrupted | 4 | 1 (25.0%) | 0 |
| DMT or No MS Treatment | 20 | 1 (5.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS)
At 1 week after vaccination period (defined as 1 week after second dose of vaccine)
Immune responseProportion of participants achieving seroconversion as defined by detection of SARS-CoV-2 serum functional antibodies one week after second dose of vaccine in participants treated concomitantly with siponimod and siponimod treatment break (yes/no)
Immune response
Other measures (3)
SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS)
Baseline; Week 1, Month 1 and Month 6 after second dose of vaccine; 1 month after booster (up to Month 12 after second dose of vaccine)
Immune responseNumber of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Baseline; Week 1, Month 1 and Month 6 after second dose of vaccine; 1 month after booster (up to Month 12 after second dose of vaccine)
Immune response• SARS-CoV-2 serum functional antibody levels one week, one month and six months after second dose of vaccine and additionally one month after an optional booster vaccination in participants treated concomitantly with siponimod versus siponimod treatment break versus first-line DMTs and in patients currently not on a DMT
Who could take part
Relapsing and progressive · 18 to 100
Inclusion Criteria: * Secondary Progressive Multiple Sclerosis (SPMS) diagnosis or with Relapsing Remitting Multiple Sclerosis (RRMS) at risk to develop SPMS (at the discretion of the treating physician) * on stable MS treatment (Siponimod, dimethylfumarate, glatirameracetate, interferon, teriflunomode) or no current treatment * no recent treatment changes Exclusion Criteria: * prior or current COVID-19 disease * SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study was to understand whether participants could mount an immune response to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or during a treatment break versus while on treatment with first-line DMTS or no current MS treatment..
Papers
Loading reviews and guidelines…
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History
Started
Apr 2021
Main results due
Sept 2021
Finished
Aug 2022
Results posted
May 2024
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