NCT00536120

The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \[KLH\]) and a recall antigen (tetanus toxoid \[Td\]), and to evaluate the effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BG00002 (natalizumab)
BIOLOGICAL	keyhole limpet hemocyanin (KLH)	KLH 1 mg administered subcutaneously (SC) in accordance with the Immucothel investigator's brochure.
BIOLOGICAL	tetanus diphtheria toxoid vaccine (Td)	Td administered in accordance with the manufacturer's prescribing information.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2007-09-27
• Last updated: 2017-02-15
• Results posted: 2011-07-29

Locations

10 sites across 1 country: United States