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Immune Responses in Health Care Personnel

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ClinicalTrials.gov Identifier: NCT03323112
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Hospital District of Helsinki and Uusimaa
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland

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. 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. The analysis will be mainly descriptive.

Condition or disease Intervention/treatment
Influenza Biological: influenza vaccine

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Immune Responses to Influenza Vaccinations and Viruses Among Health Care Personnel
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : October 14, 2027
Estimated Study Completion Date : October 14, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Influenza vaccine recipients
Health care workers vaccinated by their occupational health care according to the routine praxis.
Biological: influenza vaccine
Vaccine for prevention of influenza. Vaccines change by influenza season.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
Blood samples, PBMC


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health care professionals affiliated by HUS
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323112


Contacts
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Contact: Hanna Nohynek, MD, PhD +358 29 524 8246 hanna.nohynek@thl.fi
Contact: Ritva Syrjänen, MD, PhD +358 29 524 7918 ritva.syrjanen@thl.fi

Locations
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Finland
The Hospital District of Helsinki and Uusimaa Recruiting
Helsinki, Finland
Contact: Veli-Jukka Anttila, MD, Docent    +358 50 4271512    veli-jukka.anttila@hus.fi   
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Hospital District of Helsinki and Uusimaa
Investigators
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Principal Investigator: Hanna Nohynek, MD, PhD National Institute for Health and Welfare, Finland

Additional Information:

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Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT03323112     History of Changes
Other Study ID Numbers: FinFLU_HCPimmu_2017THL
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute for Health and Welfare, Finland:
influenza
vaccination
health care workers
immune responses
humoral immunity
cellular immunity
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs