A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab plus Early Vaccination; Belimumab plus Late Vaccination
Intervention description: 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 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.
Intervention MeSH terms: Belimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies; Vaccines; SLE; Immune System Diseases; Biological Therapy; Autoimmune Diseases; Pneumococcal Vaccines; Lupus; Immunoglobulins; Vaccination; Belimumab; Biological Agents; Immunization

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).
    

Eligibility 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.