Vaccination Response Following Administration of Ixekizumab to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations
研究概览
简要总结
The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females without compromised immune system
- •Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)
排除标准
- •Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists
- •Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
- •Have known allergy or hypersensitivity to any biologic therapy
- •Past vaccination allergy or Arthus-type hypersensitivity
- •Received a tetanus toxoid-containing vaccine within the last 5 years
- •Severe allergic reaction to Boostrix
- •Allergic to latex
- •Have been immunized with pneumococcal vaccine
- •Known hypogammaglobulinemia
- •History of Guillain-Barre Syndrome
- •Active infectious disease
- •Had a live vaccination within 1 year prior to screening, or intend to have a live vaccination during the course of the study
- •Evidence of a significant uncontrolled neuropsychiatric disorder -
- •Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self Report (16 Items) at screening
- •Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B
- •Had symptomatic herpes zoster within 3 months of screening
- •Women who are lactating
研究组 & 干预措施
Ixekizumab + Boostrix® + Pneumovax®23
Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.
Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
干预措施: Ixekizumab (Drug)
Ixekizumab + Boostrix® + Pneumovax®23
Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.
Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
干预措施: Boostrix® (Drug)
Ixekizumab + Boostrix® + Pneumovax®23
Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.
Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
干预措施: Pneumovax®23 (Drug)
Boostrix® + Pneumovax®23
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
干预措施: Boostrix® (Drug)
Boostrix® + Pneumovax®23
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
干预措施: Pneumovax®23 (Drug)
结局指标
主要结局
Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations
时间窗: Week 6
Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of \>=1.0 (International Unit (IU) and a \>=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is \<=1.0 at baseline OR a \>=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is \> 1.0 IU at baseline. Responder to the pneumococcal vaccine is defined as a \>=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against \>50% of the 23 serotypes.
次要结局
未报告次要终点