A Phase I, Prospective, Randomized, Open Label, Observer-Blind, Single Center Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Produced in Madin-Darby Canine Kidney (MDCK) Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Signs and symptoms unsolicited by vaccination
研究概览
简要总结
The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.
详细描述
Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and has a high mortality rate. Experts warn that the next influenza pandemic is imminent and could be severe and prevention and control will depend on the rapid production and worldwide distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These purified inactivated vaccine antigens were safe and could induce immune responses in animal studies. Moreover, when formulated in aluminum phosphate a stronger response was generated even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further investigations are necessary before their human safety and immunogenicity can be established. This human phase I clinical study, therefore, evaluates the safety and immunogenicity of adjuvanted H5N1 virion influenza vaccine.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥20 and ≤60 years of age
- •In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- •Willing and able to comply with all required study visits and follow-up required by this protocol
- •Must provide written informed consent
排除标准
- •Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine
- •Had any influenza vaccine within 6 months
- •Administered with any vaccine within 30 days
- •A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease
- •Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months
- •Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity
- •Any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- •Receiving immunoglobulins and/or any blood products within the three months
- •Acute disease at the time of enrolment
- •Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance
- •Breast feeding or pregnant women
结局指标
主要结局
Signs and symptoms unsolicited by vaccination
时间窗: A 21-day follow-up period after each vaccine administration
Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.
Signs and symptoms solicited by vaccination
时间窗: A 7-day follow-up period after each vaccine administration
Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.
Occurrence of adverse events and serious adverse events
时间窗: Up to 180 days after the first vaccine administration
Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.
次要结局
- Serum antibody titers to H5N1 virus(Day 42)