Clinical trial NCT01597492: A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Keywords: Antibodies
Vaccines
SLE
Immune System Diseases
Biological Therapy
Autoimmune Diseases
Pneumococcal Vaccines
Lupus
Immunoglobulins
Vaccination
Belimumab
Biological Agents
Immunization
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2012-05-14
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

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.

Primary outcomes:
measure: Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
timeFrame: Four weeks after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Paradise Valley
country: United States
facility: GSK Investigational Site
state: Arizona
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Cumberland
country: United States
facility: GSK Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: GSK Investigational Site
state: Maryland
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Duncansville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.