Clinical trial NCT02097849: Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: vaccine
pneumococcal
meningococcal
tetanus diphtheria
immune response
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) \[T cell-dependent neoantigen response\].


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.

Primary outcomes:
measure: Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
Secondary outcomes:
measure: Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Ratio of Serum Tetanus Level at Day 28 to Prevaccination
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination
timeFrame: Up to Week 4 (Day 28) postvaccination
measure: Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
timeFrame: Day 1 to Week 4
measure: Number of Participants With Shifts From Baseline in Hematology
timeFrame: Screening to Week 4
measure: Number of Participants With Shifts From Baseline in Blood Chemistry
timeFrame: Screening to Week 4
measure: Number of Participants With Abnormalities in Vital Signs
timeFrame: Screening to Week 4
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Thornton
country: United States
facility: Research Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Auburn
country: United States
facility: Research Site
state: Maine
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.