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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: BG00002 (natalizumab) (Biological); keyhole limpet hemocyanin (KLH) (Biological); tetanus diphtheria toxoid vaccine (Td) (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

The primary objectives of this study were: to evaluate the effect of TysabriŽ (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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination

Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination

Secondary outcome:

Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy

Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy

Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6

Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

- women who are breastfeeding, pregnant, or planning to become pregnant during the

study

- female subjects who are not postmenopausal for at least 1 year, surgically sterile

(does not include tubal ligation), or willing to practice effective contraception during the study

Locations and Contacts

Research Site 1, Fullerton, California 92835, United States

Research Site, Centennial, Colorado 80112, United States

Research site, Farmington Hills, Michigan 48334, United States

Research Site, Patchogue, New York 11772, United States

Research Site 3, Charlotte, North Carolina 28207, United States

Research Site 5, Oklahoma City, Oklahoma 73130, United States

Research Site, Franklin, Tennessee 37064, United States

Research Site, Dallas, Texas 75214, United States

Research Site 2, Seattle, Washington 98122, United States

Research Site 4, Charleston, West Virginia 25301, United States

Additional Information

Starting date: January 2008
Last updated: March 27, 2014

Page last updated: August 23, 2015

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