Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
研究概览
简要总结
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
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 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained.
- •Aged ≥18 to <49 years.
- •In good general health.
- •Available for the study duration, including all planned follow-up visits.
- •Females must have negative pregnancy test and be using adequate form of contraception
排除标准
- •Clinically significant abnormalities on laboratory and vital sign assessments.
- •Anaphylaxis or other serious adverse reactions
- •Administration of another vaccine within 30 days of study treatment period.
- •Physical examination indicating any significant medical condition.
- •Intention to travel out of the area prior to the study visit on Day
- •Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
- •Pregnancy.
- •Excessive alcohol consumption, drug abuse.
- •Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
研究组 & 干预措施
ChimeriVax™-JE
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
干预措施: ChimeriVax™-JE vaccine (Biological)
JE-VAX®
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
干预措施: JE-VAX® vaccine (Biological)
结局指标
主要结局
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
时间窗: Day 0 (pre-vaccination) and up to Day 56 post-vaccination
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
时间窗: Day 0 up to Day 56 post-vaccination
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
时间窗: Day 0 (Pre-vaccination) and up to Month 12 After First Dose
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. \[Seropositive status can be 'Yes' or 'No'\]
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
时间窗: Day 0 (pre-vaccination) up to month 12 post-vaccination
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
时间窗: Day 0 up to Day 6 post-vaccination
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
次要结局
未报告次要终点