Immune Response to SARS-CoV-2 mRNA Vaccines in an Open-Label Multicenter Study in Participants with Relapsing Multiple Sclerosis Treated with Ofatumumab
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design, Participants, and Treatments
2.2. Outcomes and Assessments
2.3. Administrative Procedures
2.4. Statistical Methods
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable * |
Cohort 1 Vaccination Prior to Treatment |
Cohort 2 Vaccination during Stable Treatment |
Cohort 3 Vaccination during IFN/GA/DMF/TF/ No DMT |
---|---|---|---|
N | 6 | 5 | 20 |
Age, years | 32.5 (8.1) | 32.4 (7.7) | 48.6 (12.9) |
Sex, female, n (%) | 5 (83.3) | 4 (80.0) | 16 (80.0) |
Time since diagnosis, years | 2.7 (4.9) | 1.5 (1.9) | 13.99 (10.43) |
Number of prior DMTs | 1.0 | 0.4 | 1.6 |
Number of DMTs prior to ofatumumab, n (%) | |||
0 | 4 (66.7) | 3 (60.0) | n.a. |
≥1 | 2 (33.3) a | 2 (40.0) b | n.a. |
Variable * |
Cohort 1 Vaccination Prior to Treatment |
Cohort 2 Vaccination during Stable Treatment |
Cohort 3 Vaccination during IFN/GA/DMF/TF/No DMT |
---|---|---|---|
N | 6 | 5 | 20 |
Vaccination, n (%) | |||
1st (BioNTech/Pfizer | Moderna) | 5 (83.3) | 1 (16.7) | 5 (100.0) | 0 (0) | 19 (95.0) | 1 (5.0) |
2nd (BioNTech/Pfizer | Moderna) | 5 (83.3) | 1 (16.7) | 5 (100.0) | 0 (0) | 19 (95.0) | 1 (5.0) |
Vaccination time interval, mean (SD) | |||
1st to 2nd vaccination, weeks/days | 3.0 (0.1) weeks | 3.4 (0.6) weeks | 36.8 (9.0) days |
Adverse Events, n (%) | Cohort 1 Vaccination Prior to Treatment (n = 6) | Cohort 2 Vaccination during Stable Treatment (N = 5) |
---|---|---|
Adverse events (AEs) | 6 (100.0) | 5 (100.0) |
General disorders and administration site conditions | 5 (83.3) | 3 (60.0) |
Nervous system disorders | 5 (83.3) | 4 (80.0) |
Musculoskeletal and connective tissue disorders | 1 (16.7) | 2 (40.0) |
Blood and lymphatic system disorders | 1 (16.7) | 0 (0.0) |
Infections and infestations | 3 (50.0) | 4 (80.0) |
Ear and labyrinth disorders | 0 (0.0) | 0 (0.0) |
Gastrointestinal disorders | 0 (0.0) | 1 (20.0) |
Injury, poisoning, and procedural complications | 0 (0.0) | 0 (0.0) |
Metabolism and nutrition disorders | 1 (16.7) | 0 (0.0) |
Psychiatric disorders | 0 (0.0) | 0 (0.0) |
Reproductive system and breast disorders | 0 (0.0) | 0 (0.0) |
Respiratory, thoracic and mediastinal disorders | 2 (33.3) | 1 (20.0) |
Skin and subcutaneous tissue disorders | 0 (0.0) | 1 (20.0) |
Vascular disorders | 0 (0.0) | 0 (0.0) |
Not coded | 0 (0.0) | 0 (0.0) |
AEs related to DMTs | 2 (33.3) | 3 (60.0) |
AEs related to SARS-CoV-2 vaccine | 3 (50.0) | 2 (40.0) |
AEs leading to permanent discontinuation of study medication | 0 (0.0) | 0 (0.0) |
AEs leading to temporary interruption of study medication | 0 (0.0) | 1 (20.0) |
Serious adverse events | 0 (0.0) | 1 (20.0) |
MS relapse | 0 (0.0) | 1 (20.0) |
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Ziemssen, T.; Groth, M.; Ettle, B.; Bopp, T. Immune Response to SARS-CoV-2 mRNA Vaccines in an Open-Label Multicenter Study in Participants with Relapsing Multiple Sclerosis Treated with Ofatumumab. Vaccines 2022, 10, 2167. https://doi.org/10.3390/vaccines10122167
Ziemssen T, Groth M, Ettle B, Bopp T. Immune Response to SARS-CoV-2 mRNA Vaccines in an Open-Label Multicenter Study in Participants with Relapsing Multiple Sclerosis Treated with Ofatumumab. Vaccines. 2022; 10(12):2167. https://doi.org/10.3390/vaccines10122167
Chicago/Turabian StyleZiemssen, Tjalf, Marie Groth, Benjamin Ettle, and Tobias Bopp. 2022. "Immune Response to SARS-CoV-2 mRNA Vaccines in an Open-Label Multicenter Study in Participants with Relapsing Multiple Sclerosis Treated with Ofatumumab" Vaccines 10, no. 12: 2167. https://doi.org/10.3390/vaccines10122167
APA StyleZiemssen, T., Groth, M., Ettle, B., & Bopp, T. (2022). Immune Response to SARS-CoV-2 mRNA Vaccines in an Open-Label Multicenter Study in Participants with Relapsing Multiple Sclerosis Treated with Ofatumumab. Vaccines, 10(12), 2167. https://doi.org/10.3390/vaccines10122167