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)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2015-24-09
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.
- 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.
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):
Trial location(s)
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98133
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43623
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35249
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Paradise Valley, Arizona, United States, 85253
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Maryland, United States, 21502
Status
Study Complete
Location
GSK Investigational Site
Hagerstown, Maryland, United States, 21740
Status
Study Complete
Location
GSK Investigational Site
Burlington, Vermont, United States, 05401
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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