NCT04736147已完成1 期
A Phase 1 Open-label Study to Assess the Immunogenicity, Safety, and Reactogenicity of JNJ-64300535, a DNA Vaccine Administered by Electroporation-mediated Intramuscular Injection, in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens
研究概览
简要总结
The purpose of this study is to evaluate the cellular immunogenicity of 3 monthly electroporation-mediated intramuscular (IM) injections of JNJ-64300535 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must sign an informed consent form (ICF) indicating that he understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- •Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Must be healthy as confirmed by medical history, physical examination, and vital signs performed at screening
排除标准
- •Weight of less than (<) 50 kilograms (kg) and a body mass index (BMI) <19.0 or greater than (>) 29.9 kilogram per meter square (kg/m^2) at screening
- •History of Human Immunodeficiency Virus (HIV) infection or a positive HIV antibody test at screening
- •History of HBV infection, measured by the presence of HBsAg and/or anti-HBc antibodies
- •History of seizure disorders unless seizure free for >5 years
- •Has a non-removable active electronic stimulation device
结局指标
主要结局
Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens
时间窗: Up to Day 67
Percentage of participants responding against HBV Core or Pol vaccine antigens will be reported.
次要结局
- Number of Participants With Solicited Systematic Adverse Events(Up to Day 64)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters(Up to Day 225)
- Number of Participants With Clinically Significant Abnormalities in Physical Examination(Up to Day 225)
- Number of Participants With Serious Adverse Events (SAEs)(Up to Day 225)
- Number of Participants With Solicited Local Adverse Events (AEs)(Up to Day 64)
- Number of Participants With Unsolicited Adverse Events(Up to Day 225)
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Up to Day 225)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)(Up to Day 113)
- Percentage of Participants With a Positive T-cell Response Against HBV Core or Pol Vaccine Antigens(Up to Day 225)
- Magnitude of the T-cell Responses Against HBV Core or Pol Vaccine Antigens(Up to Day 225)
- Number of Cytokines of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) T-cell Responses Against HBV Core or Pol Vaccine Antigens(Up to Day 225)
- Breadth of the T-cell Responses Against HBV Core or Pol Vaccine Antigens(Up to Day 225)
- Frequency of Intramuscular TriGrid Delivery System version 2.0 (TDS-IM v2.0) Device Faulty Conditions(Up to Day 57)
研究者
研究点 (2)
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