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

NCT02097849 ↗

Phase 2 Completed 71 enrolled Biogen

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2015-02-28
Primary completion: 2016-05-02
Completion: 2016-05-02

Outcome

Missed primary endpoint

registry p = 0.692; Difference in proportion -0.04 (95% CI -0.27 to 0.19) NCT02097849 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	23-valent pneumococcal polysaccharide vaccine	Vaccine	0.5 ml	Intramuscular
Subject	dimethyl fumarate	Unknown	240 mg	—
Subject	meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)	Vaccine	0.5 ml	Intramuscular
Comparator	non-pegylated interferon	Unknown	—	—
Subject	tetanus diphtheria toxoids vaccine	Vaccine	0.5 ml	Intramuscular