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

Completed · Phase 4

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00536120

Run by

Biogen

People needed

60

Starts

2008-01-01

Expected to finish

2009-12-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• able to give written informed consent
• diagnosis of a relapsing form of MS and must fall within the therapeutic indication stated in the approved label for Tysabri
• aged 18-60 years, inclusive at the time of consent
• free of signs and symptoms suggestive of any serious opportunistic infection, based on medical history, physical examination, or laboratory testing
• must have a known history of tetanus toxoid immunization
• Major Exclusion Criteria:
• tetanus toxoid vaccination less than 2 years prior to Screening
• known hypersensitivity to tetanus-diphtheria vaccine or KLH or any other administered vaccinations or their components (such as thimerosal)
• known allergy to shellfish
• history of active tuberculosis or undergoing treatment for tuberculosis
• previous exposure to KLH or vaccines containing KLH components (e.g., cancer vaccines)
• known history of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection
• history of, or available abnormal laboratory results indicative of any significant disease
• history of malignancy
• history of organ transplantation (including anti-rejection therapy)
• history of severe allergic or anaphylactic reactions or known drug hypersensitivity
• a clinically significant infectious illness within 30 days prior to the Screening visit
• prior exposure to Tysabri, rituximab, any murine protein, or any therapeutic monoclonal antibody at any time
• receipt of intravenous (IV) or intramuscular (IM) immunoglobulin within 6 months of screening
• live virus, bacterial vaccines, or any other vaccines within 3 months of screening
• treatment with immunosuppressant medications within 6 months prior to screening
• treatment with cyclophosphamide within 1 year prior to screening
• treatment with immunomodulatory medications (interferon beta and glatiramer acetate) within 2 weeks prior to screening
• treatment with systemic corticosteroids within 4 weeks prior to screening
• treatment with any investigational product or approved therapy or vaccination for investigational use within 6 months prior to Screening

Where it is running

• Research Site 1 — Fullerton, California, United States
• Research Site — Centennial, Colorado, United States
• Research site — Farmington Hills, Michigan, United States
• Research Site — Patchogue, New York, United States
• Research Site 3 — Charlotte, North Carolina, United States
• Research Site 5 — Oklahoma City, Oklahoma, United States
• Research Site — Franklin, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site 2 — Seattle, Washington, United States
• Research Site 4 — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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