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

NCT01597492 | Completed Phase 4 Results

• 2 other identifiers: 115470HGS1006-C1117
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 15

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Antibodies; Vaccines; SLE; Immune System Diseases; Biological Therapy; Autoimmune Diseases; Pneumococcal Vaccines; Lupus; Immunoglobulins; Vaccination; Belimumab; Biological Agents; Immunization

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Belimumab plus Early Vaccination

EXPERIMENTAL

Belimumab plus Early Vaccination

Biological: Belimumab plus Early Vaccination

Belimumab plus Late Vaccination

EXPERIMENTAL

Belimumab plus Late Vaccination

Biological: Belimumab plus Late Vaccination

Interventions

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.

Also known as: BENLYSTA™

Belimumab plus Early Vaccination

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.

Also known as: BENLYSTA™

Belimumab plus Late Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Human Genome Sciences Inc., a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (15)

GSK Investigational Site

Birmingham, Alabama, 35249, United States

Location

GSK Investigational Site

Paradise Valley, Arizona, 85253, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71103, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

Cumberland, Maryland, 21502, United States

Location

GSK Investigational Site

Hagerstown, Maryland, 21740, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

Location

GSK Investigational Site

Toledo, Ohio, 43623, United States

Location

GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

GSK Investigational Site

Austin, Texas, 78731, United States

Location

GSK Investigational Site

Austin, Texas, 78758, United States

Location

GSK Investigational Site

Houston, Texas, 77090, United States

Location

GSK Investigational Site

Burlington, Vermont, 05401, United States

Location

GSK Investigational Site

Seattle, Washington, 98133, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 29336179 DERIVED

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Immune System Diseases; Autoimmune Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 14, 2012
• Study Start: May 31, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 24, 2015
• Last Updated: August 16, 2018
• Results First Posted: July 25, 2016

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.

Locations

US (15)