Evaluation of Priming Effects by Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on the Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.
研究概览
简要总结
This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects
详细描述
It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine (produced by Microgen Russia) which will be given to healthy adult volunteers who participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University in February to May 2013.
A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and 20 received placebo (control group) in the previous study will be asked to return to the clinic to receive a single dose of an inactivated H5 influenza vaccine.
Total foloww up is 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2
- •Age 18-49 years old
- •Having Thai ID card or equivalent
- •Anti HIV - Negative
- •All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
- •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
- •Receiving other vaccination against H5N1
- •History of bronchial asthma
- •History of chronic lung diseases
- •History of chronic rhinitis
- •History of immunodeficiency state
- •History of immunosuppression< 6 months prior to immunization
- •History of heavy smoking (more than 5 packs per day)
- •History of alcoholic (pure drink 200 ml per day)
- •Acute infectious and noninfectious diseases (within 2 weeks)
- •HIV 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
- •Poultry workers
研究组 & 干预措施
OrniFlu® inactivated vaccine
干预措施: OrniFlu® inactivated vaccine (Biological)
结局指标
主要结局
Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.
时间窗: 12 Months
次要结局
- Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.(12 Month)
研究者
Punnee Pitisuttithum
Professor
Mahidol University