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11-026-1
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Evaluation of Inflammatory Response to Influenza Vaccination in Sickle Cell Disease.
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Dr. Biree Andemariam
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This study will evaluate the response of humans with sickle cell disease to routine vaccinations, specifically immunization for the influenza virus. It succeeds a pilot/feasibility study that was conducted and confirmed that appropriate specimens could be collected from human subjects with sickle cell disease and healthy controls and that the necessary assays could be run to examine inflammatory markers and components of the immune system present in the blood of subjects. The aim of this study is to utilize blood samples obtained from both individuals with sickle cell disease and healthy volunteers in order to determine whether SCD individuals exist at baseline in a state of heightened inflammation as compared to the healthy volunteers. The study will then evaluate whether sickle cell patients have an enhanced inflammatory response to the influenza vaccine as compared to healthy individuals through an equivocal analysis from a blood
draw 4-6 weeks post-vaccination. In summary this study will consist of two separate blood draws, a pre-vaccination blood draw within 4 weeks of influenza vaccine administration and a post-vaccination blood draw within 4-6 weeks after immunization for the influenza vaccine.
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Blood - Sickle Cell Disease
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Healthy controls:
1.) 18 years of age or older
2.) No previous diagnosis of sickle cell disease or sickle cell trait
3.) No previous diagnosis of any other blood disorder
4.) No vaccination within past three months
5.) No current medications
6.) No current prescription steroids or steroid use within past six months
7.) Plan on receiving flu vaccine within the next four weeks
Sickle Cell subjects:
1.) 18 years of age or older
2.) No vaccination within past three months
3.) No hospitalization within the past month
4.) No current prescription steroids or steroid use within past six months
5.) Plan on receiving flu vaccine within the next four weeks
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Sasia-Marie Jones. Telephone: Not available. Email:sajones@uchc.edu
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Enrolling/recruiting. For current recruitment status, recruitment will occur in Fall of 2011
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