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

Systemic Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597492
• Other study ID #: 115470
• Secondary ID: HGS1006-C1117
• Status: Completed
• Phase: Phase 4
• Start date: May 31, 2012
• Est. completion date: September 24, 2015

Study information

• Verified date: July 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 24, 2015
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Burlington	Vermont
United States	GSK Investigational Site	Cumberland	Maryland
United States	GSK Investigational Site	Duncansville	Pennsylvania
United States	GSK Investigational Site	Hagerstown	Maryland
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Paradise Valley	Arizona
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Four weeks after vaccination

External Links

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