2024-515372-12-00招募中4 期
Immune responses to influenza vaccinations and viruses among health care personnel
Finnish Institute For Health And Welfare1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年8月27日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Humoral immunity to influenza virus strains included in the vaccines of the current and past seasons as well as circulating influenza strains will be assessed from the serum samples with traditional hemagglutination inhibition (HI). Microneutralization or neutralization test (NT) may also be used.
研究概览
简要总结
To assess the presence and titer of antibodies against circulating influenza virus strains and vaccine strains of the current season from pre- and post-vaccination serum samples.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female individuals aged 18 to 64 years
- •Members of health care or laboratory personnel in HUS having decided to take the seasonal influenza vaccination by the routine occupational health care service
- •General good health as established by or volunteer’s own statement
- •Written informed consent
- •Presumably able and willing to participate in the study during the starting influenza season
排除标准
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Administration (longer than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months before the vaccination; oral corticosteroids in dosages of 20 mg/day or more prednisolone or equivalent are excluded; inhaled or topical steroids are allowed.
- •Pregnancy or lactation
- •Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever)
- •Contraindication for influenza vaccination
- •Any other criteria which, in the investigator’s or dedicated study staff member’s opinion, would compromise the ability of a subject to participate in the study, a subject’s well-being, or the outcome of the study
- •Exclusion criteria for participation in the subgroup giving together 3 times 60 ml blood for analyses of cellular immunity: weight less than 50 kg or diagnosed or suspected anaemia
结局指标
主要结局
Humoral immunity to influenza virus strains included in the vaccines of the current and past seasons as well as circulating influenza strains will be assessed from the serum samples with traditional hemagglutination inhibition (HI). Microneutralization or neutralization test (NT) may also be used.
Humoral immunity to influenza virus strains included in the vaccines of the current and past seasons as well as circulating influenza strains will be assessed from the serum samples with traditional hemagglutination inhibition (HI). Microneutralization or neutralization test (NT) may also be used.
次要结局
- Cellular immunity will be assessed from thawed PBMC samples after stimulation with circulating influenza virus and vaccine antigens in cell culture.
- Cytokine (IFN-gamma and others) responses will be assessed e.g. by measuring the concentration of secreted cytokines in the cell culture media with Luminex technology.
- mRNA expression of cytokines and other factors (e.g. inflammatory mediators and transcription factors) can be measured from specific cell populations enriched with magnetic cell separation or sorted with FACSAria flow cytometer.
研究者
Merit Melin
Scientific
Finnish Institute For Health And Welfare
研究点 (1)
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