Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.
Administered as described in the treatment arm
Administered as described in the treatment arm
Administered as described in the treatment arm
Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.
Research Site
Gilbert, Arizona, United States
Research Site
Thornton, Colorado, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Lexington, Kentucky, United States
Research Site
Auburn, Maine, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Akron, Ohio, United States
...and 4 more locations
Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level
Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level
Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level
Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Ratio of Serum Tetanus Level at Day 28 to Prevaccination
Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination
Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination
Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination
Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.
Time frame: Up to Week 4 (Day 28) postvaccination
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
Time frame: Day 1 to Week 4
Number of Participants With Shifts From Baseline in Hematology
Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.
Time frame: Screening to Week 4
Number of Participants With Shifts From Baseline in Blood Chemistry
Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.
Time frame: Screening to Week 4
Number of Participants With Abnormalities in Vital Signs
Temperature increase: \> 38 celcius (C) or ≥ 1 C increase from baseline. Pulse increase: \> 120 beats per minute (bpm) or \> 20 bpm increase from baseline. Pulse decrease: \< 50 bpm or \> 20 bpm decrease from baseline. Systolic blood pressure (SBP) increase: \> 180 millimeters of mercury (mmHg) or \> 40 mmHg from baseline. SBP decrease: \< 90 mmHg or \> 30 mmHg decrease from baseline. Diastolic blood pressure (DBP) increase: \> 105 mmHg or \> 30 mmHg increase from baseline. DBP decrease: \< 50 mmHg or \> 20 mmHg decrease from baseline.
Time frame: Screening to Week 4
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