A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.
研究概览
简要总结
This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.
详细描述
This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV.
The whole follow-up period for each participant will be 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 60 years.
- •African in China.
- •Able to understand the content of informed consent and willing to sign the informed consent
- •Able and willing to complete all the secluded study process during the whole study follow-up period (about 1 month).
- •A body mass index (BMI) 18.5-35.0 kg/m2
- •Hemoglobin ≥110g/L for female, and ≥120g/L for male.
- •White blood cells (WBC) 4.0-10.0×109 cells/L
- •Total lymphocyte Count 0.8-4.5×109 cells/L
- •Platelets 100-300×109 cells/L
- •Alanine aminotransferase (ALT) 0-40U/L
- •Serum creatinine 44-106μmol/L
- •Active partial thromboplastin time (APTT) 20-40 seconds
- •Prothrombin time (PT) 10-14 seconds
- •Negative in HIV diagnostic blood test
- •Axillary temperature ≤37.0°C on the day of enrollment
- •General good health as established by medical history and physical examination.
排除标准
- •Family history of seizure, epilepsy, brain or mental disease
- •Participant that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol.
- •Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
- •Any acute fever disease or infections in last 7 days
- •Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
- •Hereditary angioneurotic edema or acquired angioneurotic edema
- •Urticaria in last one year
- •Asplenia or functional asplenia
- •Platelet disorder or other bleeding disorder may cause injection contraindication
- •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 blood products in last 4 months
- •Prior administration of other research medicines in last 1 month
- •Prior administration of attenuated vaccine in last 1 month
- •Prior administration of inactivated vaccine in last 14 days
- •Current anti-tuberculosis prophylaxis or therapy
- •Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives
研究组 & 干预措施
High dose
After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).
干预措施: Ad5-EBOV (Biological)
low dose
30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).
干预措施: Ad5-EBOV (Biological)
结局指标
主要结局
A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.
时间窗: From March to July, 2015
次要结局
未报告次要终点
研究者
Lanjuan Li
Academy of Engineering
First Affiliated Hospital of Zhejiang University