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Multiple Sclerosis Immune Responses to COVID-19 Vaccinations to Be Evaluated in COVER-MS Project Substudy

SAP Partner | <b>National MS Society</b>

The substudy of the COVER-MS Project includes 300 patients with multiple sclerosis and will harness Quest Diagnostic’s national network of more than 2100 patient centers to provide periodic blood samples of immune responses to COVID-19 vaccines.

Through a new collaborative effort, a group of investigators will assess immune response to COVID-19 vaccinations in patients with multiple sclerosis (MS), with the goal to learn how the number and timing of vaccine doses effects antibody levels and duration in the disease.1

The research project is a substudy of the larger COVER-MS Project, and was announced in a new partnership between Accelerated Cure Project (ACP), Quest Diagnostics, and the National Multiple Sclerosis Society. Behind the project is ACP’s iConquerMS People-Powered Research Network, for which members will have input on research questions for the study. In total, the study will gather patient-reported survey data on 300 participants from the original 1600-person study.

"Understanding the immune response to the COVID-19 vaccine doses in a longer-term study in people with MS will provide tremendous insights into not only optimal vaccine dosing for this population, but it will shed light on how vaccines may affect people with immune disorders or who are taking immunomodulatory therapies," Bruce Bebo, PhD, executive vice president, Research, National MS Society, said in a statement.1 "We have had a long and productive collaboration with Accelerated Cure Project and its iConquerMS network and we're looking forward to working with them and with Quest Diagnostics on this important project."

SARS-CoV-2 serological immunoglobulin antibody and T-cell testing used to determine COVID-19 antibody response will be provided by Quest, in addition to a decentralized clinical trial model. Here, Quest’s national network of more than 2100 patient service centers will enable participants to conveniently provide periodic blood samples. Additionally, the collaboration between the groups will provide proof-of-concept for a model of decentralized biological studies that are convenient, easy, and economical for researchers and participants alike.

Michael Racke, MD, medical director, Neurology, Quest Diagnostics, said in a statement, "We are thrilled to contribute our expertise in neuroimmunology and COVID-19 to this important research effort focused on yielding insight into the unique COVID-19 disease risks facing patients with MS. Quest's national network of patient service centers will enable the research team to ease the process of recruiting and retaining participants, surmounting a major challenge of clinical trials and other scientific research."1

Previously, in early January 2022, initial findings from COVER-MS were published. All told, COVD-19 vaccine reactogenicity profiles and the associated factors were similar between patients with MS and the general population. In that retrospective analysis, investigators intended to generate real-world MS-specific vaccine safety information, particularly in the context of specific disease-modifying therapies (DMTs).2

A total of 719 patients with MS from iConquerMS were included in the initial report. Of them, 64% reported experiencing a reaction after their first vaccination shot, most of which were pain at injection site (54%), fatigue (34%), headache (28%), and malaise (21%). An additional 17% reported a severe reaction. Younger age, being female, prior COVID-19 infection, and receiving the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vs BNT162b2 (Pfizer-BioNTech) vaccines were associated with reactions after the first vaccine dose.

Similar relationships were observed for severe reaction, including higher odds of reactions among those with MS with more physical impairment and lower odds of reactions for those with MS on an alpha4-integrin blocker or sphingosine-1-phosphate (S1P) receptor modulator. Second vaccination shots led to reactions in 74% of the 442 patients with MS who opted for it; however, the reaction profiles were similar to those reported after the first shot. Notably, young patients with MS and those who receive the mRNA-1273 (Moderna) vs BNT162b2 vaccine reported higher reactogenicity after the second shot, whereas those on a S1P receptor modulator or fumarate were significantly less likely to report a reaction.

"As a person with MS who is treated with an immunomodulator that may affect antibody formation, I want to know how well the COVID-19 vaccines promote antibody development and how long they last compared with people who don't have MS," Phyllis Klein, PhD, RN, cochair of the COVER-MS steering committee, said in a statement.1 "Knowing this could tell us if we need to change intervals between boosters and perhaps eventually help determine the optimal booster dosing for people with MS."

REFERENCES
1. Accelerated Cure Project, Quest Diagnostics and the National Multiple Sclerosis Society form research collaboration to evaluate COVID-19 vaccine efficacy in patients with multiple sclerosis. News release. Accelerated Cure Project for MS. September 1, 2022. Accessed September 6, 2022. https://www.prnewswire.com/news-releases/accelerated-cure-project-quest-diagnostics-and-the-national-multiple-sclerosis-society-form-research-collaboration-to-evaluate-covid-19-vaccine-efficacy-in-patients-with-multiple-sclerosis-301616710.html
2. Briggs FB, Mateen FJ, Schmidt H, et al. COVID-19 vaccination reactogenicity in persons with multiple sclerosis. Neurol Neuroimmunol Inflamm. 2022;9(1):e1104. doi:10.1212/NXI.0000000000001104.