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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00536120
• Date of registration: 25/09/2007
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
• Scientific 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
• Date of first enrolment: January 2008
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00536120
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: BG00002 (natalizumab)

Biological: keyhole limpet hemocyanin (KLH)

Biological: tetanus diphtheria toxoid vaccine (Td)

Primary Outcome(s)

Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination [Time Frame: 28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)]

Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination [Time Frame: 28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)]

Secondary Outcome(s)

Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6 [Time Frame: Month 0 (Baseline), Month 3, and Month 6]

Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy [Time Frame: Month 0 (Baseline), Month 3]

Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6 [Time Frame: Month 0 (Baseline), Month 3, and Month 6]

Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy [Time Frame: Month 0 (Baseline), Month 6]

Secondary ID(s)

101MS404

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/07/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00536120