A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Occurrence of solicited adverse reactions after vaccination
研究概览
简要总结
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
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
- 8 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 50 years
- •Able to understand the content of informed consent and signed the informed consent
- •Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
- •Negative in HIV diagnostic blood test on day of enrollment
- •Axillary temperature ≤37.0°C on the day of enrollment
- •Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
- •General good health as established by medical history and physical examination.
排除标准
- •Infected by Ebola virus (inquiry)
- •Vaccination with other Ebola vaccine (inquiry)
- •HIV infection or other serious immunodeficiency disease (inquiry)
- •Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
- •Family history of brain or mental disease
- •Woman who is pregnant or breast-feeding
- •Any acute fever disease or infections in last 7 days
- •Major congenital defects or not well-controlled chronic illness
- •Asplenia or functional asplenia
- •Platelet disorder or other bleeding disorder
- •Faint at the sight of blood or needles.
- •Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
- •Prior administration of other research medicines in last 1 month
- •Prior administration of attenuated vaccine(s) in the last one month
- •Prior administration of inactivated vaccine(s) in the last 14 days
- •Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives
研究组 & 干预措施
Group C
(0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
干预措施: Placebo (Biological)
Group B
(4×10^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10^10vp/vial), total dose of 8×10^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
干预措施: Ebola Vaccine (Biological)
Group A
(4×10^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10^10 vp/vial), one shot in each arm, total dose of 1.6×10^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
干预措施: Ebola Vaccine (Biological)
结局指标
主要结局
Occurrence of solicited adverse reactions after vaccination
时间窗: 7 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
时间窗: 168 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
时间窗: 14 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
时间窗: 28 days after vaccination
次要结局
- Occurrence of serious adverse reaction during the whole follow-up period(6 months)
- Neutralizing antibody titers response to human Ad5(168 days after vaccination)
- Occurrence of unsolicited adverse reactions after vaccination(28 days after vaccination)
- Post-vaccination Rate of infected with HIV(6 months)
- Neutralizing antibody titers response to human Ad5(14 days after vaccination)
- Neutralizing antibody titers response to human Ad5(28 days after vaccination)