Immune Responses in Health Care Personnel

Influenza Clinical Trial

Official title:

Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323112
• Other study ID #: FinFLU_HCPimmu_2017THL
• Status: Recruiting
• Start date: October 18, 2017
• Est. completion date: October 14, 2027

Study information

• Verified date: September 2023
• Source: Finnish Institute for Health and Welfare
• Contact: Hanna Nohynek, MD, PhD
• Phone: +358 29 524 8246
• Email: hanna.nohynek[@]thl.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 14, 2027
• Est. primary completion date: October 14, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• influenza vaccine
Vaccine for prevention of influenza. Vaccines change by influenza season.

Locations

Country	Name	City	State
Finland	The Hospital District of Helsinki and Uusimaa	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Finnish Institute for Health and Welfare	Hospital District of Helsinki and Uusimaa

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	10 years
Other	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	10 years
Other	Developing methods to measure immunity against vaccine preventable diseases	developing laboratory methodologies to assess immunity to influenza and other microbes causing vaccine preventable diseases	10 years
Primary	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	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	10 years
Secondary	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	10 years
Secondary	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	10 years