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

Relapsing Forms of Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097849
• Other study ID #: 109MS307
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2014
• Last updated: August 23, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Must have a confirmed diagnosis of RRMS 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 IgG 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

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
• 23-valent pneumococcal polysaccharide vaccine
Administered as described in the treatment arm
• 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.

Locations

Country	Name	City	State
United States	Research Site	Akron	Ohio
United States	Research Site	Auburn	Maine
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Ft. Lauderdale	Florida
United States	Research Site	Gilbert	Arizona
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Lexington	Kentucky
United States	Research Site	New York	New York
United States	Research Site	Round Rock	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a =2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels from pre-vaccination to 4 weeks after Td vaccination.		Up to week 4 post vaccination	No
Secondary	Proportion of participants with a =4-fold rise in anti-tetanus serum IgG levels from pre-vaccination to 4 weeks after Td vaccination.		Up to week 4 post vaccination	No
Secondary	Proportion of participants with a =2-fold and a =4-fold rise in anti-pneumococcal serum IgG levels against serotypes 3 and 8 from pre-vaccination to 4 weeks after PPSV23 vaccination.		Up to week 4 post vaccination	No
Secondary	Proportion of participants with a =2-fold and a =4-fold rise in anti-meningococcal serum IgG levels against serotype C From pre-vaccination to 4 weeks after MCV4 vaccination.		Up to week 4 post vaccination	No
Secondary	The geometric mean titer ratios from pre-vaccination to 4 weeks after Td, PPSV23, and MCV4 vaccinations.		Up to week 4 post vaccination	No
Secondary	Number of participants experiencing adverse events (AEs)		Day 1 to Week 4	Yes
Secondary	Number of participants experiencing serious adverse events (SAEs).		Screening to Week 4	Yes