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RecruitingNCT03323112Updated Aug 20, 2025

Immune Responses in Health Care Personnel

An observational study in Influenza, sponsored by Finnish Institute for Health and Welfare. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Finnish Institute for Health and Welfare · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Influenza

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Keywords

  • influenza
  • vaccination
  • health care workers
  • immune responses
  • humoral immunity
  • cellular immunity
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Health care professionals affiliated by HUS

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Influenza vaccine recipients

    Health care workers vaccinated by their occupational health care according to the routine praxis.

    Biological: influenza vaccine

Interventions

  • Biologicalinfluenza vaccine

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

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • The Hospital District of Helsinki and Uusimaa
    Helsinki, Finland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03323112
Lead sponsor
Finnish Institute for Health and Welfare
Collaborators
Hospital District of Helsinki and Uusimaa
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Oct 18, 2017
Primary completion
Oct 14, 2027 (estimated)
Completion
Oct 14, 2027 (estimated)
Last update
Aug 20, 2025

Study contacts

Hanna Nohynek, MD, PhD
Contact
hanna.nohynek@thl.fi
+358 29 524 8246
Merit Melin, PhD
Contact
merit.melin@thl.fi
+358 29 524 8903
Hanna Nohynek, MD, PhD
principal investigator · Finnish Institute for Health and Welfare

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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