Disease: Multiple Sclerosis
Type of study: Observational trial
Coordinating investigator: Hilde M. Torgauten
Study director: Øivind Torkildsen
Background: Previous studies have shown that vaccination in general is safe for MS-patients. Vaccination is not a risk factor for developing MS, and do not represent a risk for further disease activity or disease progression. Nevertheless, live vaccines are not recommended for patients that receive diseasemodifying therapies.
Vaccination response and immunity is another challenge related to vaccination of MS-patients receiving disease-modifying therapies. These medications have immunomodulatory or immunosuppressive effects and may therefore influence the immune response to various vaccines. Although limited data are available, we have previously shown that interferon-beta therapies do not influence the vaccination response, while fingolimod, and especially mitoxantrone, may influence the humoral vaccination responses. Other studies have shown that rituximab, ocrelizumab, alemtuzumab and teriflunomide, but not dimethyl fumarate, seem to reduce vaccine responses. Based on these limited data on vaccine response in MS patients receiving disease-modifying therapies, and the challenge of COVID-19 vaccination, the MS group have performed a study on efficacy and safety of COVID-19 vaccines in MS-patients.
The objective is to evaluate the efficacy and safety of COVID-19 vaccines in MS-patients with and without disease-modifying therapies, compared to healthy population controls not receiving immunotherapy.
Design: This is a prospective observational trial evaluating vaccination responses of COVID-19 vaccines in MS-patients receiving different diseasemodifying therapies.
Primary endpoint: Humoral vaccine response and clinical efficacy of COVID-19 vaccine.
This is a collaborative project, chaired by Professor Rebecca Cox at the Influenza Centre at the University of Bergen. Other participants include researchers at Oslo University Hospital, University of Oslo, and Sørlandet Hospital Trust, as well as the Norwegian MS Registry.
Status: Patients have been recruited for participation at Haukeland University Hospital, Oslo University Hospital and Sørlandet Hospital Trust, as well as through the Norwegian MS Registry.
Results so far have shown that rituximab and fingolimod reduce the humoral vaccination response to COVID-19 vaccines, and that booster vaccines improve this vaccine response (PMID: 35072702; PMID: 34670844). Further studies of COVID-19 vaccination in rituximab treated patients have shown that, despite reduced humoral vaccination response, the vaccine is clinically effective in reducing severe
Covid-19 disease (manuscript submitted).
Participating centres
- Haukeland University Hospital, Bergen
- Oslo University Hospital, Oslo
- Sørlandet Hospital, Kristiansand
Funding
- The Research Council of Norway, Neuro-SysMed
- The Regional Health Authority of Western Norway
- Haukeland University Hospital
- Oslo University Hospital
- Sørlandet Hospital, Kristiansand
- The University of Bergen
- The Norwegian MS Registry
- The Kjell Alme Legacy, Bergen