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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01597492
First received: May 8, 2012
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
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).

Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Belimumab plus Early Vaccination
Biological: Belimumab plus Late Vaccination
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination [ Time Frame: Four weeks after vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 79
Study Start Date: May 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab plus Early Vaccination
Belimumab plus Early Vaccination
Biological: Belimumab plus Early Vaccination
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.
Other Name: BENLYSTA™
Experimental: Belimumab plus Late Vaccination
Belimumab plus Late Vaccination
Biological: Belimumab plus Late Vaccination
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.
Other Name: BENLYSTA™

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597492

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35249
United States, Arizona
GSK Investigational Site
Paradise Valley, Arizona, United States, 85253
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
GSK Investigational Site
Cumberland, Maryland, United States, 21502
GSK Investigational Site
Hagerstown, Maryland, United States, 21740
United States, New York
GSK Investigational Site
New York, New York, United States, 10016
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Pennsylvania
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78731
GSK Investigational Site
Austin, Texas, United States, 78758
GSK Investigational Site
Houston, Texas, United States, 77090
United States, Vermont
GSK Investigational Site
Burlington, Vermont, United States, 05401
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98133
GSK Investigational Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01597492     History of Changes
Other Study ID Numbers: 115470  HGS1006-C1117 
Study First Received: May 8, 2012
Results First Received: April 28, 2016
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Antibodies
Vaccines
SLE
Immune System Diseases
Biological Therapy
Autoimmune Diseases
Pneumococcal Vaccines
Lupus
Immunoglobulins
Vaccination
Belimumab
Biological Agents
Immunization

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Belimumab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 25, 2016