Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: vaccine pneumococcal meningococcal tetanus diphtheria immune response
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 71
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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 arm 2: 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

Interventions: intervention 1: dimethyl fumarate intervention 2: tetanus diphtheria toxoids vaccine intervention 3: 23-valent pneumococcal polysaccharide vaccine intervention 4: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) intervention 5: non-pegylated interferon
Intervention descriptions: intervention 1: Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera. intervention 2: Administered as described in the treatment arm intervention 3: Administered as described in the treatment arm intervention 4: Administered as described in the treatment arm intervention 5: Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.

Protocol document: