The Effects of TYSABRI Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Although TYSABRI has been studied in clinical trials, and has been approved by the FDA for the treatment of MS, no information is available on the effects of vaccination (immunization against disease, such as measles or tetanus) in patients who receive TYSABRI. This study is designed to determine the effects of TYSABRI treatment on vaccinations in people. In order to do this, some people will receive 6 doses of TYSABRI before being vaccinated, and some people will receive only the vaccinations (no treatment for MS will be given for approximately 3 months).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
|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|
- Proportion of KLH Responders at Day 28 [ Time Frame: 28 days after immunization ] [ Designated as safety issue: Yes ]KLH responders were defined as those participants who had at least a two-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.
- Proportion of Tetanus Responders at Day 28 [ Time Frame: 28 days after immunization ] [ Designated as safety issue: Yes ]Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.
|Study Start Date:||January 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Group 1 subjects will receive 9 monthly doses of TYSABRI 300 mg IV, and will then receive vaccinations with neoantigen and recall antigen at specified timepoints following the 7th dose.
Biological: TYSABRI (natalizumab)
TYSABRI 300 mg IV once every 4 weeks,to be administered over 1 hour, with a 1-hour observation period to follow the infusion
No Intervention: 2
Group 2 subjects will receive only vaccinations with neoantigen and recall antigen at specified timepoints. They will not receive any treatment for their MS.
The purpose of the study is to see whether TYSABRI affects the ability of your immune system to respond to a vaccination that you have had before (tetanus), and to a new vaccination, keyhole limpet hemocyanin (KLH), which most people have not had before. KLH is often used to study the immune system. This study will measure levels of antibodies that the body makes to tetanus and KLH after each vaccination. This study will also see whether TYSABRI affects the immune cells in the blood that fight infection (white cells and lymphocytes).
Subjects will be randomly assigned to a treatment group. This is done so that each group has a similar number and mix of people. Each group will have 23 people.
Each subject will have an equal chance of being placed in either group.
- Group 1 will receive TYSABRI and vaccinations.
- Group 2 will receive vaccinations only (no MS treatment will be given for approximately 3 months).
This is an open-label study, which means that you and your doctor will know what treatment group you are assigned to. Both Group 1 and Group 2 will receive the same vaccinations:
- Tetanus (1 vaccination)
- KLH (3 vaccinations, 14 days apart)
Subjects assigned to Group 1 will come to the clinic for about 10 clinic visits over a 9-month period. Additional clinic visits may be required if neurological symptoms worsen.
Subjects assigned to Group 2 will come to the clinic for 4 clinic visits over a 3-month period. Group 2 subjects will receive vaccinations only, and will not receive treatment for their MS during this study.
|United States, California|
|Research Site 1|
|Fullerton, California, United States, 92835|
|United States, Colorado|
|Centennial, Colorado, United States, 80112|
|United States, Michigan|
|Farmington Hills, Michigan, United States, 48334|
|United States, New York|
|Patchogue, New York, United States, 11772|
|United States, North Carolina|
|Research Site 3|
|Charlotte, North Carolina, United States, 28207|
|United States, Oklahoma|
|Research Site 5|
|Oklahoma City, Oklahoma, United States, 73130|
|United States, Tennessee|
|Franklin, Tennessee, United States, 37064|
|United States, Texas|
|Dallas, Texas, United States, 75214|
|United States, Washington|
|Research Site 2|
|Seattle, Washington, United States, 98122|
|United States, West Virginia|
|Research Site 4|
|Charleston, West Virginia, United States, 25301|