Phase II Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers
研究概览
简要总结
The purpose of this study is to evaluate immune response and safety of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, Thailand in healthy Thais.
详细描述
It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as being tested in phase I.
150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. All will be separated in 4 batches; Batch 1: 36 participants (24 vaccinees and 12 placebos) Batch 2: 38 participants (25 vaccinees and 13 placebos) Batch 3: 38 participants (25 vaccinees and 13 placebos) Batch 4: 38 participants (26 vaccinees and 12 placebos)
Each batch will be admitted in the isolation ward for 5 days after each immunization mainly for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 28 days apart. Total follow up is 60 day.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-49 years old
- •Having Thai ID card or equivalent
- •Are seronegative to the specific H5 influenza virus determined by antibody titer less than 1:40 by HAI test to the corresponding antigen.
- •Anti HIV - Negative
- •All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value)
- •Able to read and write and sign written informed consent.
排除标准
- •Known history of egg allergy
- •Having had recently influenza infection confirmed as H5
- •History of bronchial asthma
- •History of chronic lung diseases
- •History of chronic rhinitis
- •History of immunodeficiency state
- •History of immunosuppression
- •History of heavy smoking (more than 5 rolls per day)
- •History of alcoholic (pure drink 200 ml per day)
- •Acute infectious and noninfectious diseases (within 2 weeks)
- •Exacerbation of chronic diseases or cancer or HIV positives
- •Anamnestic leukocytosis, hepatitis B and C positives
- •The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
- •Participation in other research study or stop participant less than 1 month
- •Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
- •Any concomitant medication with Aspirin
- •Poultry workers
研究组 & 干预措施
A/17/turkey/Turkey/05/133 (H5N2)
100 participants will be admitted in the isolation ward for 5 days after each immunization mainly for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 28 days apart and will be followed for the total of 60 days.
干预措施: Avian Flu Vaccine (Biological)
Placebo
50 participants will be admitted in the isolation ward for 5 days after each administered placebo mainly for safety assessment. Two doses placebo will be given by intranasal route 28 days apart and will be followed for the total of 60 days.
干预措施: Avian Flu Vaccine (Biological)
结局指标
主要结局
Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers
时间窗: within 60 days after screening
次要结局
未报告次要终点
研究者
Punnee Pitisuttithum
Professor
Mahidol University