Phase 4
Completed N=41
Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)
Source: ClinicalTrials.gov NCT04792567 ↗Enrolled (actual)
41
Serious AEs
7.3%
Results posted
May 2024
Primary outcomePrimary: Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS) — 52.9; 75.0; 90.0 percentage of participants
◆ Published Evidence
Emerging
7citations · ~2 / year
Assessing the immune response to SARS-CoV-2 mRNA vaccines in siponimod-treated patients: a nonrandomized controlled clinical trial (AMA-VACC).
Summary
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..
Linked Publications
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Assessing the immune response to SARS-CoV-2 mRNA vaccines in siponimod-treated patients: a nonrandomized controlled clinical trial (AMA-VACC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS) |
52.9; 75.0; 90.0 | — |
| SECONDARY SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS) |
-3.8; -0.3; -2.6; 38.1; 64.0; 82.6 | — |
| SECONDARY Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS |
0; 0; 1; 10; 3; 19 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04792567) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.