Immune Responses in Health Care Personnel

ConditionInfluenza
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorFinnish Institute for Health and Welfare

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • influenza vaccine

    Biological/Vaccine

    Vaccine for prevention of influenza. Vaccines change by influenza season.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Influenza vaccine recipients1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
10 years

Secondary outcomes

1

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

Time frame
10 years
2

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

Time frame
10 years
3

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

Time frame
10 years

Other outcomes

1

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

Time frame
10 years
2

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

Time frame
10 years
3

Developing methods to measure immunity against vaccine preventable diseases

developing laboratory methodologies to assess immunity to influenza and other microbes causing vaccine preventable diseases

Time frame
10 years

Sponsors and contacts

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Finnish Institute for Health and Welfare

Lead sponsor

Hospital District of Helsinki and Uusimaa

Collaborator