About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Health care professionals affiliated by HUS
Trial design
Cohort
Prospective
Treatments tested in this trial
influenza vaccine
Biological/VaccineVaccine for prevention of influenza. Vaccines change by influenza season.
Treatment groups
Trial outcomes
Primary outcomes
Humoral immunity against each present season's vaccine and circulating influenza strains
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
Secondary outcomes
Humoral immunity against previous seasons' vaccine and circulating influenza strains
To assess the presence and titer of antibodies to circulating influenza strains and vaccine virus strains of previous seasons from pre- and post-vaccination serum samples
Cellular immunity against current and previous seasons' vaccine and circulating influenza strains
The cellular immune responses to circulating influenza viruses and vaccine strains of the current and previous seasons from pre- and post-vaccination peripheral blood mononuclear cells (PBMCs) and cell culture supernatants
Effect of repeated vaccination against influenza
The effect of the number of previous influenza vaccinations on the quality and quantity of Humoral and cellular immunity to circulating influenza strains and vaccine strains of the current and previous seasons
Other outcomes
Factors affecting humoral and/or cellular immune responses to influenza viruses or vaccination
Exploration of biological or chemical factors that are/will be known or suspected to affect the humoral and/or cellular immune responses to influenza viruses or vaccination
Immunity against other microbes causing vaccine preventable diseases among health care workers
Assessment of humoral and cellular immunity to microbes other than influenza virus causing vaccine preventable diseases
Developing methods to measure immunity against vaccine preventable diseases
developing laboratory methodologies to assess immunity to influenza and other microbes causing vaccine preventable diseases
Sponsors and contacts
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Finnish Institute for Health and Welfare
Lead sponsor
Hospital District of Helsinki and Uusimaa
Collaborator