2023-509178-44-00招募中4 期
Avian and seasonal influenza vaccine induced immune responses
Finnish Institute For Health And Welfare1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test
研究概览
简要总结
The main objective of this study is to evaluate the humoral and cell-mediated immune responses induced by the customized avian influenza vaccine, specifically against the H5N1 2.3.4.4b clade.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years
- •Belongs to the target group of the avian influenza vaccine
- •Is planning to receive at least one dose of the avian influenza vaccine
- •Is able to understand the given written and oral information
- •Has given written informed consent
- •Home address in Finland
- •Is able to give samples 3 weeks after each vaccine dose and preferably also participate in the follow-up at 6 and 12 months
- •Pregnant and lactating women can participate in the study
排除标准
- 未提供
结局指标
主要结局
Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test
Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test
次要结局
- Rate of seroconversion defined as the percentage of subjects with either a pre-vaccination MNT titer < 1:10 and a post vaccination MNT titer ≥ 1:80 or a pre-vaccination MNT titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
- Geometric mean titers at pre- and post-vaccination
- Detectable increase in T cell (CD4+ and CD8+) responses against H5N1 virus specific antigens in avian influenza virus vaccinated individuals
研究者
Hanna Nohynek
Scientific
Finnish Institute For Health And Welfare
研究点 (1)
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