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OpenTrials
Completed

NCT Number: NCT02097849

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants 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].

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Key information

Conditions

Relapsing Forms of Multiple Sclerosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dimethyl fumarate

Drug

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

Other names: DMF, BG00012, Tecfidera

tetanus diphtheria toxoids vaccine

Biological

Administered as described in the treatment arm

Other names: Td, Tenivac

23-valent pneumococcal polysaccharide vaccine

Biological

Administered as described in the treatment arm

Other names: Pneumovax 23, PPSV23

meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)

Biological

Administered as described in the treatment arm

Other names: MCV4, Menveo

non-pegylated interferon

Drug

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

Other names: IFN

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2014
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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