A Study to Evaluate the Immune Response of Healthy Individuals for the 2017-2018 Seasonal Flu Vaccine

Overview

About this study

The purpose of this study is to evaluate the immune response of healthy individuals to the 2017-2018 seasonal flu vaccine.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is 19 - 79 years of age.
  • Willingness and ability to provide informed consent.
  • Subject is able to participate fully in all aspects of the study.
  • Generally healthly, as determined by study investigators, and not meeting any of the exclusion criteria listed below.
  • Is eligible for the 2017-2018 and/or 2018-2019 seasonal influenza vaccine.

Exclusion Criteria: 

  • Subject has received this year’s influenza vaccine (2017-2018 or 2018-2019 season; as relevant to each particular season) outside of this study.
  • Subject has a history of severe adverse reaction associated with an influenza vaccine.
  • Subject is allergic to egg proteins and chicken proteins.
  • Subject has a history of Guillain-Barre syndrome.
  • Subject has a known or suspected immunodeficiency.
  • Subject is on a medication that directly affects the outcome, i.e., treatment with immunosuppressive therapy including:
    • cytotoxic agents or systemic corticosteroids,  systemic corticosteroids for treatment of an acute illness in the last 30 days;
    • a blood product (including immunoglobulin) within 6 months prior to enrollment in the study;
    • anticoagulant therapy (not including anti-platelet drugs such as aspirin and clopidogrel) that would contraindicate intramuscular injection.
  • Subject has had a recent (within 6 months) myocardial infarction, fracture, cancer or unplanned hospitalisation.
  • Subject weighs ≤ 110 lbs.
  • Subject has donated blood in the past 56 days or plans to donate blood at time of study or within 8 weeks after their participation in the study ends weeks after their participation in the study ends.
  • Pregnancy (as determined by history or self-report).
  • Trying to conceive at time of study or for 28 days after vaccination.
  • Transgender women/men will be excluded due to the potential effect of this status on the immune response.
  • Note that individuals with stable chronic disease (HTN that is well controlled, T2DM with A1C < 8, CHF if NYHA class I or II) can be included.

 

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amir Sadighi Akha, M.D., D.Phil.

Closed for enrollment

Contact information:

Lisa Hines

(507)266-1710

Hines.Lisa@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20357698

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