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Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)

NCT04792567

CompletedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Secondary Progressive Multiple Sclerosis

Interventions: BAF312, Baseline disease modifying therapies (DMTs), BNT162, mRNA-1273

Countries: Germany

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..

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (10)

Mittweida, Saxony, Germany
Bogen, Germany
Chemnitz, Germany
Dresden, Germany
Düsseldorf, Germany
Neuburg an der Donau, Germany
Pforzheim, Germany
Regensburg, Germany
Rülzheim, Germany
Ulm, Germany