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

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.