PACTR201509001259869尚未招募未知
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
Ministry of Health & Sanitation0 个研究点目标入组 500 人开始时间: 2015年9月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 50 Year(s)（—）
- 性别
- All
入选标准
- •1. Aged between 18 and 50 years
- •2. Able to understand the content of informed consent and signed the informed consent
- •3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
- •4. Negative in HIV diagnostic blood test on the day of enrollment
- •5. Axillaty temperature ?37.0°C on the day of enrollment
- •6. Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
- •7. General good health as established by medical history and physical examination.
排除标准
- •1. Infected by Ebola virus (inquiry)
- •2. Vaccination with other Ebola vaccine (inquiry)
- •3. HIV infection or other serious immunodeficiency disease (inquiry)
- •4. Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
- •5. Family history of brain or mental disease
- •6.Woman who is pregnant or breast-feeding
- •7. Any acute fever disease or infections in last 7 days
- •8. Major congenital defects or not well-controlled chronic illness
- •9. Asplenia or functional asplenia
- •10. Platelet disorder or other bleeding disorder
- •11. Faint at the sight of blood or needles.
- •12. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
- •13. Prior administration of other research medicines in last 1 month
- •14. Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives
研究者
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