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NCT Number: NCT03323112

Immune Responses in Health Care Personnel

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.

Recruiting

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital District of Helsinki and Uusimaa

Helsinki, Finland

Location status: Recruiting

Location contact

Veli-Jukka Anttila, MD, Docent

CONTACT

[email protected]

+358 50 4271512

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

influenza vaccine

Biological

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

Primary outcomes

  1. Humoral immunity against each present season's vaccine and circulating influenza strains

    Time frame: 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

Secondary outcomes

  1. Humoral immunity against previous seasons' vaccine and circulating influenza strains

    Time frame: 10 years

    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

  2. Cellular immunity against current and previous seasons' vaccine and circulating influenza strains

    Time frame: 10 years

    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

  3. Effect of repeated vaccination against influenza

    Time frame: 10 years

    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

  1. Factors affecting humoral and/or cellular immune responses to influenza viruses or vaccination

    Time frame: 10 years

    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

  2. Immunity against other microbes causing vaccine preventable diseases among health care workers

    Time frame: 10 years

    Assessment of humoral and cellular immunity to microbes other than influenza virus causing vaccine preventable diseases

  3. Developing methods to measure immunity against vaccine preventable diseases

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Nohynek, MD, PhD

CONTACT

[email protected]

+358 29 524 8246

Merit Melin, PhD

CONTACT

[email protected]

+358 29 524 8903

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Hospital District of Helsinki and Uusimaa

Registry information

Official study title

Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2017
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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