A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Study in Healthy Subjects to Determine the Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74
研究概览
简要总结
The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo. Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine series, assess change in anti-hepatitis B surface antibodies and assess the safety and tolerability of a single 750-mg IV dose of vedolizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vedolizumab 750 mg
Vedolizumab 750 mg, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
干预措施: Vedolizumab (Drug)
Vedolizumab 750 mg
Vedolizumab 750 mg, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
干预措施: Hepatitis B vaccine (Biological)
Vedolizumab 750 mg
Vedolizumab 750 mg, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
干预措施: Oral cholera vaccine (Biological)
Placebo
Vedolizumab placebo-matching, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
干预措施: Placebo (Drug)
Placebo
Vedolizumab placebo-matching, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
干预措施: Hepatitis B vaccine (Biological)
Placebo
Vedolizumab placebo-matching, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
干预措施: Oral cholera vaccine (Biological)
结局指标
主要结局
Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74
时间窗: Day 74
Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.
次要结局
- Number of Participants With Adverse Events (AEs)(From the first dose of study medication through Day 127)
- Percentage of Participants With an Immune Response to Oral Cholera Vaccine(Baseline and Day 74)
- Anti-Hepatitis B Surface Antibody Over Time(Baseline and Days 18, 32, 60 and 74)