This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The data of this study will support the labels for ozanimod in multiple sclerosis (MS) because the effect of ozanimod on the vaccination response of MS participants is of interest to participants and prescribers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Tdap
PPSV23
Seasonal influenza vaccine
Stanford University
Palo Alto, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Hartford Healthcare CT
Southington, Connecticut, United States
University of Florida Health
Gainesville, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Serologic response to tetanus toxoid criteria are as follows - if pre vaccination antibody titer is ≤0.10 IU/mL, post-vaccination level ≥0.40 IU/mL; if pre-vaccination antibody titer is \>0.10 IU/mL and ≤2.7 IU/mL, at least a 4-fold increase in titer; if pre-vaccination antibody titer is\>2.7 IU/mL, at least a 2-fold increase in titer.
Time frame: Day 28
Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \>= 0.1 International Units per milliliter (IU/mL).
Time frame: Day 28
Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)
Serological response to PPSV23 was defined as the percentage of participants with a ≥2-fold increase in anti-pneumococcal polysaccharide vaccine titer in \>5 of the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F
Time frame: Day 28
Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)
Serological protection against PPSV23 was defined as the percentage of participants with Anti-pneumococcal polysaccharide IgG concentration \>= 1.3 μg/mL in the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F associated with increased risk of invasive and/or severe disease, including death.
Time frame: Day 28
Number of Participants With Adverse Events
Adverse events include events with onset date on or after the study medication first dose date until end of study visit after the vaccine administration. Serious AEs was defined as is any AE occurring at any dose of vaccination from Day 1 to the end of the study that results in death, Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of death from the AE), Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.
Time frame: Day 1 to Day 28
Number of Participants With Abnormalities in Blood Chemistry Parameters
Blood samples were collected to assess laboratory parameters
Time frame: Day 1 to Day 28
Number of Participants With Abnormalities in Blood Hematology Parameters
Blood samples were collected to assess laboratory parameters
Time frame: Day 1 to Day 28
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Albumin
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to assess laboratory parameters.
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Hematocrit
Blood samples were collected to assess laboratory parameters. Participants with baseline and post-baseline data available at the specified timepoint are included in the analysis.
Time frame: Baseline (Day 1) and End of Study (Day 28)
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Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
Port Orange, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
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Northbrook, Illinois, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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