Immune Responses in Health Care Personnel

NCT03323112 | Recruiting

• 1 other identifier: FinFLU_HCPimmu_2017THL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

influenza; vaccination; health care workers; immune responses; humoral immunity; cellular immunity

Outcome Measures

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

  10 years

Secondary Outcomes (3)

• Humoral immunity against previous seasons' vaccine and circulating influenza strains

  10 years

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

  10 years

• Effect of repeated vaccination against influenza

  10 years

Other Outcomes (3)

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

  10 years

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

  10 years

• Developing methods to measure immunity against vaccine preventable diseases

  10 years

Study Arms (1)

Influenza vaccine recipients

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

Biological: influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

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

Influenza vaccine recipients

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Health care professionals affiliated by HUS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• Hospital District of Helsinki and Uusimaa: collaborator

Study Sites (1)

The Hospital District of Helsinki and Uusimaa

Helsinki, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, PBMC

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hanna Nohynek, MD, PhD

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Nohynek, MD, PhD

CONTACT

+358 29 524 8246; hanna.nohynek@thl.fi

Merit Melin, PhD

CONTACT

+358 29 524 8903; merit.melin@thl.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 26, 2017
• Study Start: October 18, 2017
• Primary Completion (Estimated): October 14, 2027
• Study Completion (Estimated): October 14, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)