Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
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.
1 other identifier
interventional
71
1 country
14
Brief 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) \[T cell-dependent neoantigen response\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2015
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedStudy Start
First participant enrolled
February 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2016
CompletedResults Posted
Study results publicly available
June 2, 2017
CompletedJune 2, 2017
April 1, 2017
1.2 years
March 25, 2014
May 1, 2017
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to Week 4 (Day 28) postvaccination
Secondary Outcomes (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
- +10 more secondary outcomes
Study Arms (2)
Non-Pegylated IFN Treated Plus Vaccinations
ACTIVE COMPARATORParticipants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
Tecfidera Treated Plus Vaccinations
EXPERIMENTALParticipants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (14)
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Thornton, Colorado, 80233, United States
Research Site
Fort Lauderdale, Florida, 33312, United States
Research Site
Sarasota, Florida, 34243, United States
Research Site
Indianapolis, Indiana, 46202, United States
Research Site
Lexington, Kentucky, 40513, United States
Research Site
Auburn, Maine, 04210, United States
Research Site
New York, New York, 10016, United States
Research Site
Charlotte, North Carolina, 28203, United States
Research Site
Akron, Ohio, 44320, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Dayton, Ohio, 45417, United States
Research Site
Round Rock, Texas, 78761, United States
Research Site
San Antonio, Texas, 78258, United States
Related Publications (1)
von Hehn C, Howard J, Liu S, Meka V, Pultz J, Mehta D, Prada C, Ray S, Edwards MR, Sheikh SI. Immune response to vaccines is maintained in patients treated with dimethyl fumarate. Neurol Neuroimmunol Neuroinflamm. 2017 Nov 15;5(1):e409. doi: 10.1212/NXI.0000000000000409. eCollection 2018 Jan.
PMID: 29159204DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2014
First Posted
March 27, 2014
Study Start
February 28, 2015
Primary Completion
May 2, 2016
Study Completion
May 2, 2016
Last Updated
June 2, 2017
Results First Posted
June 2, 2017
Record last verified: 2017-04