The Effects of Tysabri Treatment on Vaccination Response and Lymphocyt
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
- Keyhole limpet hemocyanin
- tetanus diphtheria toxoid vaccine (Td)
Results by group
Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination
28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Tysabri Plus Vaccinations | 89 percentage of participants | 19 | |
| Vaccinations Only | 83 percentage of participants | 23 |
Tysabri Plus Vaccinations
Vaccinations Only
Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination
28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Tysabri Plus Vaccinations | 94 percentage of participants | 16 | |
| Vaccinations Only | 100 percentage of participants | 24 |
Tysabri Plus Vaccinations
Vaccinations Only
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Tysabri Plus Vaccinations | 30 | 3 (10.0%) | |
| Vaccinations Only | 30 | 2 (6.7%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination
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
28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)
Other measures (4)
Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy
Month 0 (Baseline), Month 3
Immune responseMean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy
Month 0 (Baseline), Month 6
Immune responseMean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6
Month 0 (Baseline), Month 3, and Month 6
Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6
Month 0 (Baseline), Month 3, and Month 6
Who could take part
Relapsing MS · 18 to 60
Show the full 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- A Study Utilising Data From European Union (EU) National Multiple Scle
Running, not recruiting
Still running
- A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated M
Stopped early
Stopped
- A Study to Investigate the Radiological Onset of Action After Treatmen
Phase 4 · Stopped early
Stopped
- The 'Wearing Off' Effect of DMT
Completed
No results found
- A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacody
Phase 3 · Stopped early
Stopped: not working
History
Started
Jan 2008
Main results due
Nov 2009
Finished
Dec 2009
Results posted
Jul 2011