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

This study is currently recruiting participants.
Verified December 2012 by GlaxoSmithKline
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: February 28, 2013
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to assess the impact of belimumab on immune response to both pneumococcal vaccine and tetanus toxoid in subjects with Systemic Lupus Erythematosus (SLE).


Condition Intervention Phase
Lupus Erythematosus, Systemic
 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:

Drug Information available for: Belimumab
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune Response to Tetanus Toxoid and Pneumococcal Vaccines [ Time Frame: 4 weeks after vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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). Tetanus toxoid and pneumococcal vaccinations are administered on the same day 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). Tetanus toxoid and pneumococcal vaccinations are administered on the same day 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 vaccinations against pneumococcus and tetanus toxoid. Patients will be randomized to receive vaccinations 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
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 levels of antibodies to tetanus toxoid and pneumococcal vaccine that are below protective levels.
  • 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 tetanus or 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.
  • Have human immunodeficiency virus (HIV) or test positive for hepatitis B or hepatitis C.
  • Have current drug or alcohol abuse or dependence.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597492

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, Arizona
GSK Investigational Site Recruiting
Paradise Valley, Arizona, United States, 85253
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
United States, Louisiana
GSK Investigational Site Not yet recruiting
Shreveport, Louisiana, United States, 71103
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
United States, Texas
GSK Investigational Site Not yet recruiting
Austin, Texas, United States, 78731
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Recruiting
Austin, Texas, United States, 78758
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Recruiting
Houston, Texas, United States, 77090
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( 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
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Antibodies
Vaccines
SLE
Tetanus Toxoid
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

ClinicalTrials.gov processed this record on May 23, 2013