Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

Biogen

Status and phase: Completed; Phase 2

Conditions: Relapsing Forms of Multiple Sclerosis

Treatments: Drug: non-pegylated interferon; Biological: tetanus diphtheria toxoids vaccine; Drug: dimethyl fumarate; Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent); Biological: 23-valent pneumococcal polysaccharide vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097849

109MS307

Details and patient eligibility

About

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].

Enrollment: 71 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Non-Pegylated IFN Treated Plus Vaccinations

Active Comparator group

Description:

Participants 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

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)

Biological: tetanus diphtheria toxoids vaccine

Drug: non-pegylated interferon

Tecfidera Treated Plus Vaccinations

Experimental group

Description:

Participants 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

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)

Drug: dimethyl fumarate

Biological: tetanus diphtheria toxoids vaccine