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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 16
- 主要终点
- Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Belimumab plus Late Vaccination
Belimumab plus Late Vaccination
干预措施: Belimumab plus Late Vaccination (Biological)
Belimumab plus Early Vaccination
Belimumab plus Early Vaccination
干预措施: Belimumab plus Early Vaccination (Biological)
结局指标
主要结局
Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
时间窗: Four weeks after 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.
次要结局
未报告次要终点