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2024年8月27日

概览

阶段: 4 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Finnish Institute For Health And Welfare
入组人数: 1500
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.
状态: 尚未招募
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

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.

注册库

euclinicaltrials.eu

开始日期

2024年8月27日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

研究者

发起方

Finnish Institute For Health And Welfare

责任方

Principal Investigator

主要研究者

Merit Melin

Scientific

Finnish Institute For Health And Welfare

入排标准

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.

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.