NCT02097849

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.
BIOLOGICAL	tetanus diphtheria toxoids vaccine	Administered as described in the treatment arm
BIOLOGICAL	23-valent pneumococcal polysaccharide vaccine	Administered as described in the treatment arm
BIOLOGICAL	meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)	Administered as described in the treatment arm
DRUG	non-pegylated interferon	Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.

Timeline

• Start date: 2015-02-28
• Primary completion: 2016-05-02
• Completion: 2016-05-02
• First posted: 2014-03-27
• Last updated: 2017-06-02
• Results posted: 2017-06-02

Locations

14 sites across 1 country: United States