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| ID | Type | Description | Link |
|---|---|---|---|
| HGS1006-C1117 | Other Identifier | Human Genome Sciences Inc. |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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).
All patients in this study will receive belimumab plus standard therapy for SLE and vaccination against pneumococcus. Patients will be randomized to receive pneumococcal vaccination either 4 weeks prior (early vaccination group) or 24 weeks after (late vaccination group) their first belimumab dose. Vaccine response will be assessed 4 weeks after vaccine administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab plus Early Vaccination | Experimental | Belimumab plus Early Vaccination |
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| Belimumab plus Late Vaccination | Experimental | Belimumab plus Late Vaccination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab plus Early Vaccination | Biological | Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 28, 42, 56, and every 28 days thereafter through Week 32 (9 doses). Pneumococcal vaccination is administered 4 weeks prior to the first dose of belimumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination | A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28. | Four weeks after vaccination |
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Key Inclusion Criteria:
Key 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):
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35249 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29336179 | Derived | Azoicai T, Antoniu S, Caruntu ID, Azoicai D, Antohe I, Gavrilovici C. Belimumab and antipneumococcal vaccination in patients with systemic lupus erythematosus. Expert Rev Clin Immunol. 2018 Mar;14(3):175-177. doi: 10.1080/1744666X.2018.1429269. Epub 2018 Jan 22. |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 79 participants were enrolled, of which 34 were randomised to the early cohort and 45 were randomized to the late cohort. All randomized participants received at least 1 dose of vaccine and/or belimumab and were included in the Intent-to-Treat (ITT) Population.
Eligible participants with systemic lupus erythematosus (SLE) were randomized in 7:9 ratio to receive pneumonococcal vaccination either 4 weeks prior (early cohort) or 24 weeks after (late cohort) their first belimumab dose of 10 milligram (mg)/kilogram (kg) intravenously (IV).
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab Plus Early Vaccination | Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Belimumab plus Late Vaccination | Biological | Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 0, 14, 28, and then every 28 days thereafter through Week 28 (9 doses). Pneumococcal vaccination is administered 24 weeks after the first dose of belimumab. |
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| Paradise Valley |
| Arizona |
| 85253 |
| United States |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Cumberland | Maryland | 21502 | United States |
| GSK Investigational Site | Hagerstown | Maryland | 21740 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Austin | Texas | 78731 | United States |
| GSK Investigational Site | Austin | Texas | 78758 | United States |
| GSK Investigational Site | Houston | Texas | 77090 | United States |
| GSK Investigational Site | Burlington | Vermont | 05401 | United States |
| GSK Investigational Site | Seattle | Washington | 98133 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| Belimumab Plus Late Vaccination |
Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab Plus Early Vaccination | Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE. |
| BG001 | Belimumab Plus Late Vaccination | Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination | A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28. | As-treated Population: all participants who received at least one dose of belimumab. All analyses of vaccine titers were performed on the As-treated Population. | Posted | Number | Participants | Four weeks after vaccination |
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Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 8 weeks following administration of the last dose of belimumab).
SAEs and non-serious AEs were reported for the ITT population, comprised of participants who were randomized to treatment, and received at least one dose of study medication. Treatment-emergent AEs were those that occurred on or after the first belimumab infusion, which was Week 4 for the early cohort and Week 0 for the late cohort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belimumab Plus Early Vaccination | Belimumab plus Early Vaccination | 4 | 34 | 21 | 34 | ||
| EG001 | Belimumab Plus Late Vaccination | Belimumab plus Late Vaccination | 3 | 45 | 32 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any event | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Pericarditis lupus | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
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| Glomerulonephritis proliferative | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Investigations | MedDRA 18.0 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 18.0 | Systematic Assessment |
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| Any event | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any event | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Bronchitis bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Any event | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Any event | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D007154 | Immune System Diseases |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
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| Male |
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| Black or African American |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Mixed Race |
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