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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Belimumab plus Early Vaccination
Belimumab plus Late Vaccination
Sponsored by
Human Genome Sciences Inc., a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Antibodies, Vaccines, SLE, Immune System Diseases, Biological Therapy, Autoimmune Diseases, Pneumococcal Vaccines, Lupus, Immunoglobulins, Vaccination, Belimumab, Biological Agents, Immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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.

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):

    • 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Belimumab plus Early Vaccination

Belimumab plus Late Vaccination

Arm Description

Belimumab plus Early Vaccination

Belimumab plus Late Vaccination

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2012
Last Updated
July 20, 2018
Sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01597492
Brief Title
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 31, 2012 (Actual)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 24, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Antibodies, Vaccines, SLE, Immune System Diseases, Biological Therapy, Autoimmune Diseases, Pneumococcal Vaccines, Lupus, Immunoglobulins, Vaccination, Belimumab, Biological Agents, Immunization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belimumab plus Early Vaccination
Arm Type
Experimental
Arm Description
Belimumab plus Early Vaccination
Arm Title
Belimumab plus Late Vaccination
Arm Type
Experimental
Arm Description
Belimumab plus Late Vaccination
Intervention Type
Biological
Intervention Name(s)
Belimumab plus Early Vaccination
Other Intervention Name(s)
BENLYSTA™
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Belimumab plus Late Vaccination
Other Intervention Name(s)
BENLYSTA™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
Description
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.
Time Frame
Four weeks after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. 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): 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
GSK Investigational Site
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
GSK Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
GSK Investigational Site
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
GSK Investigational Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
GSK Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
GSK Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
GSK Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
GSK Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://clinicalstudydatarequest.com
Citations:
PubMed Identifier
29336179
Citation
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.
Results Reference
derived
Links:
URL
https://clinicalstudydatarequest.com
Description
IPD for this study will be made available via the Clinical Study Data Request site.

Learn more about this trial

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

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