Phase 4 N=41 Treatment

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

Secondary Progressive Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT04792567 ↗

Enrolled (actual)

Serious AEs

7.3%

Results posted

May 2024

Primary outcome: Primary: Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS) — 52.9; 75.0; 90.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: BAF312 (Drug); Baseline disease modifying therapies (DMTs) (Drug); BNT162 (Biological); mRNA-1273 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Sep 2021

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	—

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..

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04792567). 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.