Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Humoral immunity against each present season's vaccine and circulating influenza strains
研究概览
简要总结
This is an investigator-initiated 10 year long open cohort observational study, aiming to increase the understanding of the humoral and cellular immunological mechanisms of vaccination against influenza, including effects of repeated vaccination, the duration of protection, immunity against circulating viruses, as well as factors affecting the immunological responses and immunity against other vaccine preventable infectious diseases among health care personnel.
详细描述
Influenza vaccination is given according to the normal routine of Hospital District of Helsinki and Uusimaa (HUS) occupational health care. Blood samples will be collected before vaccination, 5 weeks after vaccination and 6 months after vaccination. Both the same participants and also new participants will be recruited each year. The analysis will be mainly descriptive.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
研究组 & 干预措施
Influenza vaccine recipients
Health care workers vaccinated by their occupational health care according to the routine praxis.
干预措施: influenza vaccine (Biological)
结局指标
主要结局
Humoral immunity against each present season's vaccine and circulating influenza strains
时间窗: 10 years
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
次要结局
- Cellular immunity against current and previous seasons' vaccine and circulating influenza strains(10 years)
- Humoral immunity against previous seasons' vaccine and circulating influenza strains(10 years)
- Effect of repeated vaccination against influenza(10 years)