Last updated: 11/07/2018 09:32:56

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects with Systemic Lupus Erythematosus (SLE)

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GSK study ID
115470
See study documents
Clinicaltrials.gov ID
NCT01597492
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (belimumab; HGS1006) on Vaccine Responses in Subjects with Systemic Lupus Erythematosus (SLE)
Trial description: The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of participants with positive antibody responses to at least one of the 23 pneumococcal vaccine serotypes 4 weeks post-vaccination

Timeframe: Four weeks after vaccination

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Belimumab plus Early Vaccination
  • Biological/vaccine: Belimumab plus Late Vaccination
    • Enrollment:
    79
    Primary completion date:
    2015-24-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chatham W, Chadha A, Fettiplace J, Kleoudis C, Bass D, Roth D, Gordon D. A randomized, open-label study to investigate the effect of belimumab on pneumococcal vaccination in patients with active, autoantibody-positive systemic lupus erythematosus. Lupus. 2017;26(14):1483-1490
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    GlaxoSmithKline
    Study date(s)
    May 2012 to September 2015
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
    • Active SLE disease.
    • Pregnant or nursing.
    • Have received any prior treatment with belimumab.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
    • Active SLE disease.
    • Autoantibody-positive.
    • Have antibodies with titers >1.0 microgram (mcg)/mL to no more than 9 of the 23 serotypes present in the pneumococcal vaccine.
    • Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
    Exclusion criteria:
    • Pregnant or nursing.
    • Have received any prior treatment with belimumab.
    • Have received a live vaccine within the past 30 days.
    • Have received a pneumococcal vaccination with the past 5 years.
    • Have a history of severe allergic reaction to a vaccine, contrast agents (such as those used for x-rays and CT scans), or biological medicines.
    • Have required management of an infection or have had infections that keep coming back within the past 60 days.

      • Hepatitis B: Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HB surface antigen (HBsAg) and anti-HB core antibody (anti-HBc):

      • Subjects positive for HBsAg are excluded.
      • Subjects negative for HBsAg but positive for anti-HBc, regardless of anti-HBs antibody status, are excluded.
    • Hepatitis C: Positive test for Hepatitis C antibody.
    • Known human immunodeficiency virus (HIV) infection.
    • Have current drug or alcohol abuse or dependence.
    • Have a Grade 3/4 immunoglobulin (Ig)G deficiency (IgG level <400 milligrams [mg]/ deciliter [dL]) or IgA deficiency (IgA level <10 mg/dL).
    • Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or suicidal ideation with some intent to act in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78731
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71103
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98133
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99204
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78758
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 15 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-24-09
    Actual study completion date
    2015-24-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    IPD for this study will be made available via the Clinical Study Data Request site.
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