Phase 4
Completed N=60
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Source: ClinicalTrials.gov NCT00536120 ↗Enrolled (actual)
60
Serious AEs
8.3%
Results posted
Jul 2011
Primary outcomePrimary: Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination — 89; 83 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination |
89; 83 | — |
| PRIMARY Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination |
94; 100 | — |
| SECONDARY Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy |
39.6; 35.7; 51.8; 68.7; 135.2 | — |
| SECONDARY Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy |
52.4; 48.2; 67.1; 73.5; 164.8 | — |
| SECONDARY Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6 |
9.9; 72.7; 80.5 | — |
| SECONDARY Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6 |
633.7; 419.5; 434.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00536120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.