Phase I 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
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate safety and reactogenicity of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, in Thailand to previously healthy Thais.
详细描述
It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A phase II study is planned to be conducted following review of results of this phase.
Phase I: It is a double blind randomized placebo controlled trial involving 24 participants age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted in the isolation ward for 10-14 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 21 days apart. Each group of 4 participants will be immunized at a time at 30-60 mins interval. All participants will be followed 21 days after each immunization. Total follow up is 60 day.
研究设计
- 研究类型
- Interventional
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
- •The volunteers who have family members with immunodeficiency
- •Poultry workers
- •Have undertaken international travel within the one week prior to immunization
研究者
Punnee Pitisuttithum
Professor
Mahidol University