Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling

Overview

About this study

The purpose of this study is to provide novel information describing how immune responses to inactivated influenza A/H1N1 vaccine are generated. 

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:

  • Has the subject given written informed consent?
  • Is the subject in good health?
  • Is the subject between the ages of 50 and 74 years?
  • Is the subject able to follow study procedures?
  • Is the subject expected to be available for the duration of the study?
  • Does the subject agree NOT to donate blood during the length of the study or in the 56 days after the last blood draw?
  • If the subject has any medical conditions, are those conditions stable—where stable is defined as not requiring either a significant change in therapy or a hospitalization in the last 12 weeks?

Exclusion Criteria:

  • Has subject received this year’s 2010-2011 influenza vaccine outside of this study?
  • Has the subject had a severe reaction that was associated with the influenza vaccine?
  • Is subject allergic to egg proteins (egg or egg products) and chicken proteins?
  • Does the subject have a history of Guillain-Barré syndrome?
  • Does the subject have trouble with blood draws?
  • Does the subject have a known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (e.g., for cancer, HIV, or autoimmune disease?
  • Has the subject received systemic corticosteroids for treatment of an acute illness in the last 30 days?
  • Does the subject have a serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigators opinion precludes the subject from participating in the study?
  • Has the subject received any blood products, including immunoglobulin, within 6 months of study enrollment?
  • Is the subject receiving anticoagulant therapy or have a history of bleeding diathesis that would contraindicate intramuscular (IM) injection? Note: antiplatelet drugs such as aspirin and clopidrogel are permitted.
  • Does the subject intend to receive any other investigational vaccine or agent during the course of the study?
  • If the flu season has begun, has subject been diagnosed with the flu or flu like illness or had flu-like symptoms this season?
  • Does subject have any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives?

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

Richard Kennedy, Ph.D.

Closed for enrollment

Contact information:

Scott Feeder M.S., CCRP

(507) 255-1975

Feeder.Scott@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20492437

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