Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Drug: PlaceboBiological: Seasonal influenza vaccineBiological: Tetanus toxoid vaccine
- Registration Number
- NCT01199861
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- Must have relapsing MS
- Must have lifetime tetanus vaccination
- Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
- Patients with a type of MS that is not relapsing
- Patients with history of chronic immune disease
- Certain cancers
- Diabetic patients with certain eye disorders
- Patients who are on certain immunosuppressive medications or heart medications
- Patients with certain heart conditions
- Patients with certain lung conditions
- Patients who have already received the 2010/2011 seasonal influenza vaccine
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Placebo Seasonal influenza vaccine Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Fingolimod Seasonal influenza vaccine Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Fingolimod Tetanus toxoid vaccine Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Placebo Tetanus toxoid vaccine Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Fingolimod Fingolimod Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
- Primary Outcome Measures
Name Time Method Immune Response 3 Weeks After Seasonal Influenza Vaccination Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9) Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
* Seroconversion: The pre-vaccination antibody titer measurement was \<1:10 and the post-vaccination measurement is ≥1:40.
* Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) From first dose of study drug until 45 days after the last dose of study drug (130 days). Relationship to study drug was determined by the investigator (suspected/not suspected).
A serious AE is defined as an event which fulfills one of the following criteria:
* is fatal or life-threatening;
* results in persistent or significant disability/incapacity;
* constitutes a congenital anomaly/birth defect;
* requires inpatient hospitalization or prolongation of existing hospitalization;
* is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above.Immune Response 3 Weeks After Tetanus Toxoid Booster Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9) Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:
1. Seroconversion: The pre-vaccination antibody titer measurement was \<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.Immune Response 6 Weeks After Seasonal Influenza Vaccination Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12). Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
* Seroconversion: The pre-vaccination antibody titer measurement was \<1:10 and the post-vaccination measurement is ≥1:40.
* Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12). Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.
Immune Response 6 Weeks After Tetanus Toxoid Booster Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12) Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:
1. Seroconversion: The pre-vaccination antibody titer measurement was \<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9). Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.
Trial Locations
- Locations (2)
Novartis Investigational Site
🇨🇭Basel, Switzerland
Novartis Investigative Site
🇬🇧Stoke-on-Trent, United Kingdom