Clinical trial NCT03323112: Immune Responses in Health Care Personnel
Official title: Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza
Keywords: influenza
vaccination
health care workers
immune responses
humoral immunity
cellular immunity
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Hospital District of Helsinki and Uusimaa
First posted: 2017-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care professionals affiliated by HUS

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Humoral immunity against each present season's vaccine and circulating influenza strains
timeFrame: 10 years
Secondary outcomes:
measure: Humoral immunity against previous seasons' vaccine and circulating influenza strains
timeFrame: 10 years
measure: Cellular immunity against current and previous seasons' vaccine and circulating influenza strains
timeFrame: 10 years
measure: Effect of repeated vaccination against influenza
timeFrame: 10 years
Other outcomes:
measure: Factors affecting humoral and/or cellular immune responses to influenza viruses or vaccination
timeFrame: 10 years
measure: Immunity against other microbes causing vaccine preventable diseases among health care workers
timeFrame: 10 years
measure: Developing methods to measure immunity against vaccine preventable diseases
timeFrame: 10 years
Locations:
city: Helsinki
country: Finland
facility: The Hospital District of Helsinki and Uusimaa
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Hanna Nohynek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: