AzTrials
AzTrials

Relapsing Forms of Multiple SclerosisPhase 2NCT02097849

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

A Phase 2 study testing dimethyl fumarate, tetanus diphtheria toxoids vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Relapsing Forms of Multiple Sclerosis, run by Biogen at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Forms of Multiple Sclerosis
What is being tested?
dimethyl fumarate, tetanus diphtheria toxoids vaccine and 23-valent pneumococcal polysaccharide vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
14 sitesUnited States
Study dates
28 Feb 2015to 2 May 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Research Site

    Akron, Ohio, 44320

  • Research Site

    Auburn, Maine, 04210

  • Research Site

    Charlotte, North Carolina, 28203

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Dayton, Ohio, 45417

  • Research Site

    Fort Lauderdale, Florida, 33312

  • Research Site

    Gilbert, Arizona, 85234

  • Research Site

    Indianapolis, Indiana, 46202

  • Research Site

    Lexington, Kentucky, 40513

  • Research Site

    New York, New York, 10016

  • Research Site

    Round Rock, Texas, 78761

  • Research Site

    San Antonio, Texas, 78258

  • Research Site

    Sarasota, Florida, 34243

  • Research Site

    Thornton, Colorado, 80233

Other trials in United States

About this study

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.

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].

Being tested
dimethyl fumarate, tetanus diphtheria toxoids vaccine, 23-valent pneumococcal polysaccharide vaccine, meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent), non-pegylated interferon
Keywords
vaccine, pneumococcal, meningococcal, tetanus diphtheria, immune response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dimethyl fumarateDrug

    Also called DMF, BG00012, Tecfidera

    Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.

  • tetanus diphtheria toxoids vaccineBiological

    Also called Td, Tenivac

    Administered as described in the treatment arm

  • 23-valent pneumococcal polysaccharide vaccineBiological

    Also called Pneumovax 23, PPSV23

    Administered as described in the treatment arm

  • meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)Biological

    Also called MCV4, Menveo

    Administered as described in the treatment arm

  • non-pegylated interferonDrug

    Also called IFN

    Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.

Study groups in NCT02097849
Study groupRoleWhat they receive
Non-Pegylated IFN Treated Plus VaccinationsActive comparatorParticipants 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
Receives: Biological: tetanus diphtheria toxoids vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent); Drug: non-pegylated interferon
Tecfidera Treated Plus VaccinationsExperimentalParticipants 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
Receives: Drug: dimethyl fumarate; Biological: tetanus diphtheria toxoids vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

Secondary outcomes (15)

  1. Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level

    Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.

    Measured: Up to Week 4 (Day 28) postvaccination

  2. Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

  3. Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

  4. Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

  5. Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

  6. Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

  7. Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level

    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.

    Measured: Up to Week 4 (Day 28) postvaccination

  8. Ratio of Serum Tetanus Level at Day 28 to Prevaccination

    Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.

    Measured: Up to Week 4 (Day 28) postvaccination

  9. Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination

    Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.

    Measured: Up to Week 4 (Day 28) postvaccination

  10. Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination

    Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.

    Measured: Up to Week 4 (Day 28) postvaccination

  11. Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination

    Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.

    Measured: Up to Week 4 (Day 28) postvaccination

  12. Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs

    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.

    Measured: Day 1 to Week 4

  13. Number of Participants With Shifts From Baseline in Hematology

    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.

    Measured: Screening to Week 4

  14. Number of Participants With Shifts From Baseline in Blood Chemistry

    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.

    Measured: Screening to Week 4

  15. Number of Participants With Abnormalities in Vital Signs

    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.

    Measured: Screening to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2014 (estimated)
  2. Study start28 Feb 2015
  3. Primary completion2 May 2016
  4. Study completion2 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02097849
Sponsor's protocol ID
109MS307
Status last verified
Apr 2017
First submitted
25 Mar 2014
Last updated
2 Jun 2017
Data monitoring committee
No

Publications

  • von Hehn C, Howard J, Liu S, Meka V, Pultz J, Mehta D, Prada C, Ray S, Edwards MR, Sheikh SI. Immune response to vaccines is maintained in patients treated with dimethyl fumarate. Neurol Neuroimmunol Neuroinflamm. 2017 Nov 15;5(1):e409. doi: 10.1212/NXI.0000000000000409. eCollection 2018 Jan.

    PubMed 29159204

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dimethyl fumarate, tetanus diphtheria toxoids vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Relapsing Forms of Multiple Sclerosis, run by Biogen at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level (time frame: Up to Week 4 (Day 28) postvaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02097849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in