Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
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| ClinicalTrials.gov Identifier: NCT02097849 |
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Recruitment Status :
Completed
First Posted : March 27, 2014
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
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Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
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Brief Summary:
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN).
Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T cell-dependent neoantigen response].
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate Biological: tetanus diphtheria toxoids vaccine Biological: 23-valent pneumococcal polysaccharide vaccine Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) Drug: non-pegylated interferon | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 71 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis. |
| Actual Study Start Date : | February 28, 2015 |
| Actual Primary Completion Date : | May 2, 2016 |
| Actual Study Completion Date : | May 2, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Non-Pegylated IFN Treated Plus Vaccinations
Participants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL |
Biological: tetanus diphtheria toxoids vaccine
Administered as described in the treatment arm
Other Names:
Biological: 23-valent pneumococcal polysaccharide vaccine Administered as described in the treatment arm
Other Names:
Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) Administered as described in the treatment arm
Other Names:
Drug: non-pegylated interferon Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.
Other Name: IFN |
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Experimental: Tecfidera Treated Plus Vaccinations
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL |
Drug: dimethyl fumarate
Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.
Other Names:
Biological: tetanus diphtheria toxoids vaccine Administered as described in the treatment arm
Other Names:
Biological: 23-valent pneumococcal polysaccharide vaccine Administered as described in the treatment arm
Other Names:
Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) Administered as described in the treatment arm
Other Names:
|
Primary Outcome Measures :
- Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.
Secondary Outcome Measures :
- Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.
- Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
- Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
- Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
- Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
- Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.
- Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.
- Ratio of Serum Tetanus Level at Day 28 to Prevaccination [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.
- Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.
- Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.
- Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination [ Time Frame: Up to Week 4 (Day 28) postvaccination ]Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.
- Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs [ Time Frame: Day 1 to Week 4 ]An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
- Number of Participants With Shifts From Baseline in Hematology [ Time Frame: Screening to Week 4 ]Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.
- Number of Participants With Shifts From Baseline in Blood Chemistry [ Time Frame: Screening to Week 4 ]Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.
- Number of Participants With Abnormalities in Vital Signs [ Time Frame: Screening to Week 4 ]Temperature increase: > 38 celcius (C) or ≥ 1 C increase from baseline. Pulse increase: > 120 beats per minute (bpm) or > 20 bpm increase from baseline. Pulse decrease: < 50 bpm or > 20 bpm decrease from baseline. Systolic blood pressure (SBP) increase: > 180 millimeters of mercury (mmHg) or > 40 mmHg from baseline. SBP decrease: < 90 mmHg or > 30 mmHg decrease from baseline. Diastolic blood pressure (DBP) increase: > 105 mmHg or > 30 mmHg increase from baseline. DBP decrease: < 50 mmHg or > 20 mmHg decrease from baseline.
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Must have a confirmed diagnosis of relapsing remitting MS per the 2010 McDonald criteria.
- Must have a known tetanus immunization history with most recent tetanus vaccination given 2 to 15 years prior to Screening and an anti-tetanus serum immunoglobulin titer at Screening that is less than or equal to one-half the upper limit of detection for the assay.
- Must have been on a stable approved dose of Tecfidera (240 mg twice daily [BID]) [Group 1] for ≥6 months or on a stable approved dose of a non-pegylated IFN (e.g., Avonex, Betaseron, Rebif, Extavia) [Group 2] for ≥3 months prior to Day 1.
Key Exclusion Criteria:
- Clinical relapse requiring treatment within 30 days prior to Day 1.
- Pneumococcal vaccination within 5 years prior to Screening.
- Previous exposure to meningococcal vaccines.
- Known hypersensitivity to Td, PPSV23, or MCV4 or their components.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097849
Locations
| United States, Arizona | |
| Research Site | |
| Gilbert, Arizona, United States, 85234 | |
| United States, Colorado | |
| Research Site | |
| Thornton, Colorado, United States, 80233 | |
| United States, Florida | |
| Research Site | |
| Fort Lauderdale, Florida, United States, 33312 | |
| Research Site | |
| Sarasota, Florida, United States, 34243 | |
| United States, Indiana | |
| Research Site | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kentucky | |
| Research Site | |
| Lexington, Kentucky, United States, 40513 | |
| United States, Maine | |
| Research Site | |
| Auburn, Maine, United States, 04210 | |
| United States, New York | |
| Research Site | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Research Site | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Research Site | |
| Akron, Ohio, United States, 44320 | |
| Research Site | |
| Cleveland, Ohio, United States, 44195 | |
| Research Site | |
| Dayton, Ohio, United States, 45417 | |
| United States, Texas | |
| Research Site | |
| Round Rock, Texas, United States, 78761 | |
| Research Site | |
| San Antonio, Texas, United States, 78258 | |
Sponsors and Collaborators
Biogen
Investigators
| Study Director: | Medical Director | Biogen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT02097849 |
| Other Study ID Numbers: |
109MS307 |
| First Posted: | March 27, 2014 Key Record Dates |
| Results First Posted: | June 2, 2017 |
| Last Update Posted: | June 2, 2017 |
| Last Verified: | April 2017 |
Keywords provided by Biogen:
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vaccine pneumococcal meningococcal tetanus diphtheria immune response |
Additional relevant MeSH terms:
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons |
Dimethyl Fumarate Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Antiviral Agents Anti-Infective Agents Dermatologic Agents Immunosuppressive Agents |