Phase 2
N=71
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Relapsing Forms of Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02097849 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level — 73; 68 percentage of participants — p=0.692
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dimethyl fumarate (Drug); tetanus diphtheria toxoids vaccine (Biological); 23-valent pneumococcal polysaccharide vaccine (Biological); meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (Biological); non-pegylated interferon (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level |
73; 68 | 0.692 |
| SECONDARY Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level |
61; 42 | 0.120 |
| SECONDARY Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level |
79; 66 | 0.225 |
| SECONDARY Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level |
70; 47 | 0.057 |
| SECONDARY Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level |
88; 95 | 0.300 |
| SECONDARY Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level |
85; 82 | 0.714 |
| SECONDARY Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level |
53; 53 | 0.967 |
| SECONDARY Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level |
38; 37 | 0.955 |
| SECONDARY Ratio of Serum Tetanus Level at Day 28 to Prevaccination |
6.128; 4.463 | — |
| SECONDARY Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination |
9.667; 4.741 | — |
| SECONDARY Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination |
27.000; 13.845 | — |
| SECONDARY Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination |
3.300; 3.408 | — |
| SECONDARY Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs |
18; 16; 9; 7; 2; 0 | — |
| SECONDARY Number of Participants With Shifts From Baseline in Hematology |
1; 0; 0; 0; 2; 1 | — |
| SECONDARY Number of Participants With Shifts From Baseline in Blood Chemistry |
0; 0; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Signs |
0; 0; 1; 1; 0; 0 | — |
Summary
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].
Eligibility Criteria
Key Inclusion Criteria
- Must have a confirmed diagnosis of relapsing remitting MS per the 2010 McDonald criteria.
- Must have a known tetanus immunization history with most recent tetanus vaccination given 2 to 15 years prior to Screening and an anti-tetanus serum immunoglobulin titer at Screening that is less than or equal to one-half the upper limit of detection for the assay.
- Must have been on a stable approved dose of Tecfidera (240 mg twice daily [BID]) [Group 1] for ≥6 months or on a stable approved dose of a non-pegylated IFN (e.g., Avonex, Betaseron, Rebif, Extavia) [Group 2] for ≥3 months prior to Day 1.
Key Exclusion Criteria
- Clinical relapse requiring treatment within 30 days prior to Day 1.
- Pneumococcal vaccination within 5 years prior to Screening.
- Previous exposure to meningococcal vaccines.
- Known hypersensitivity to Td, PPSV23, or MCV4 or their components.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02097849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.