NCT03485144已完成2 期
A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan
Medigen Vaccine Biologics Corp.1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年12月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
研究概览
简要总结
The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female between 20 and 70 years of age
- •Good general health as determined by physical examination, laboratory screening, and review of medical history
- •Available for the duration of the study
- •Willingness to sign the informed consent document
- •Female of childbearing potential willing to use effective contraception for the duration of the trial
排除标准
- •Females currently pregnant, as determined by positive β- human choriogonadotropin (HCG) test, and/or breast-feeding.
- •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- •Behavioral, cognitive, or psychiatric disease
- •Below lower limit of normal for absolute neutrophil count
- •Any significant alcohol or drug abuse in the past 12 months
- •History of a severe allergic reaction or anaphylaxis
- •Self-reported systemic hypersensitivity to any of the vaccine components
- •Severe asthma
- •Known HIV, Hepatitis B or hepatitis C
- •Any known immunodeficiency syndrome
- •Use of anticoagulant medications
- •Receive chronic administration of immunosuppressant drugs within 6 months prior to the administration of the study vaccine
- •Use of any investigational product within 30 days before study vaccination or at any time during the study
- •Receive administration of immunoglobulins and/or any blood products within 12 months preceding the administration of the study vaccine or at any time during the study
- •Fever or suspected fever within 72 hours prior to vaccination or tympanic temperature greater than 38°C on the day of vaccination
- •Receive administration of any licensed live attenuated vaccines within 30 days preceding the administration of the study vaccine and ending 30 days after
- •Receive administration of any licensed inactivated vaccines within 14 days preceding the administration of the study vaccine and ending 14 days after
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
研究组 & 干预措施
Placebo for TV003
Placebo Comparator
Placebo
干预措施: Placebo for TV003 (Biological)
TV003
Experimental
Live Attenuated Virus Vaccine-TetraVax-DV
干预措施: TV003 (Biological)
结局指标
主要结局
Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
时间窗: Up to Day 90 after vaccination
Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination.
次要结局
- Immunogenicity of TetraVax-DV assessed by response rates(Up to Day 90 after vaccination)
- Duration of immunogenicity of TetraVax-DV assessed by PRNT50(Up to Day 365 after vaccination)
- Frequency of viremia following vaccination(Up to Day 15 after vaccination)
- Quantity of viremia following vaccination(Up to Day 15 after vaccination)
- Duration of viremia following vaccination(Up to Day 15 after vaccination)
- Determine the number of vaccinees with recoverable dengue virus.(Up to Day 15 after vaccination)
- Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.(Up to Day 7 after vaccination.)
- Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.(Up to Day 21 after vaccination.)
- Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.(Up to Day 365 after vaccination.)
研究者
研究点 (1)
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