Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Pa
An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis.
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level | Difference in proportion -0.04 | -0.27–0.19 | 0.692 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
Compared with
- non-pegylated interferon
Given to everyone in the trial
- tetanus diphtheria toxoids vaccine
- 23-valent pneumococcal polysaccharide vaccine
- Neisseria meningitidis oligosaccharide conjugated to corynebacterium diphtheriae crm197
Immunostimulant|Oligosaccharide conjugated to Corynebacterium ciphtheriae CRM197 vaccine antigen
Results by group
Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Non-Pegylated IFN Treated Plus Vaccinations | 73 percentage of participants | 54–87 | 33 |
| Tecfidera Treated Plus Vaccinations | 68 percentage of participants | 51–82 | 38 |
Non-Pegylated IFN Treated Plus Vaccinations
Tecfidera Treated Plus Vaccinations
p = 0.692; Difference in proportion -0.04 (95% CI -0.27–0.19)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Non-Pegylated IFN Treated Plus Vaccinations | 33 | 0 (0.0%) | |
| Tecfidera Treated Plus Vaccinations | 38 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Other measures (15)
Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level
Up to Week 4 (Day 28) postvaccination
Ratio of Serum Tetanus Level at Day 28 to Prevaccination
Up to Week 4 (Day 28) postvaccination
Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination
Up to Week 4 (Day 28) postvaccination
Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination
Up to Week 4 (Day 28) postvaccination
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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].
Papers
Loading reviews and guidelines…
Related trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Phase 3 · Not yet recruiting
Still running
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Phase 3 · Not yet recruiting
Still running
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- Observational Study of Persistence on Bafiertam Treatment in Routine C
Stopped early
Stopped
- A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Scle
Phase 4 · Completed
No results found
- Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Di
Running, not recruiting
Still running
History
Started
Feb 2015
Main results due
May 2016
Finished
May 2016
Results posted
Jun 2017