Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)
AMA-VACC
An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod)
2 other identifiers
interventional
41
1 country
10
Brief 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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2021
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2022
CompletedResults Posted
Study results publicly available
May 17, 2024
CompletedJune 20, 2024
June 1, 2024
5 months
March 8, 2021
August 1, 2023
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS)
Participants who had detectable SARS-CoV-2 serum functional antibodies one week after second dose of vaccine.
At 1 week after vaccination period (defined as 1 week after second dose of vaccine)
Secondary Outcomes (2)
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)
Number 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)
Study Arms (3)
Siponimod - continuous
EXPERIMENTALContinuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
Siponimod- interrupted
EXPERIMENTALSiponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
Comparator
ACTIVE COMPARATORBaseline DMTs or no treatment during SARS-CoV-2 mRNA vaccination
Interventions
taken orally once per day (dose depends on CYP2C9 genotype)
DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC
Administerd according to the respective EU SmPC at the discretion of the treating physician independent of AMA-VACC. If suggested by local regulations and performed as part of clinical routine any type of booster/refresher vaccination (e.g. mRNA, vector, peptide) was allowed in this study.
Administerd according to the respective EU SmPC at the discretion of the treating physician independent of AMA-VACC. If suggested by local regulations and performed as part of clinical routine any type of booster/refresher vaccination (e.g. mRNA, vector, peptide) was allowed in this study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prior or current COVID-19 disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Novartis Investigative Site
Mittweida, Saxony, 09648, Germany
Novartis Investigative Site
Bogen, 94327, Germany
Novartis Investigative Site
Chemnitz, 09117, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Düsseldorf, 40211, Germany
Novartis Investigative Site
Neuburg an der Donau, 86633, Germany
Novartis Investigative Site
Pforzheim, 75172, Germany
Novartis Investigative Site
Regensburg, 93059, Germany
Novartis Investigative Site
Rülzheim, 76761, Germany
Novartis Investigative Site
Ulm, 89073, Germany
Related Publications (1)
Ziemssen T, Groth M, Rauser B, Bopp T. Assessing the immune response to SARS-CoV-2 mRNA vaccines in siponimod-treated patients: a nonrandomized controlled clinical trial (AMA-VACC). Ther Adv Neurol Disord. 2022 Nov 8;15:17562864221135305. doi: 10.1177/17562864221135305. eCollection 2022.
PMID: 36381503DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 11, 2021
Study Start
April 19, 2021
Primary Completion
September 6, 2021
Study Completion
August 15, 2022
Last Updated
June 20, 2024
Results First Posted
May 17, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.