Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood

Ki vehet részt

• 2-49-year-old male and female patients undergoing tonsillectomy for obstructive sleep apnea or other non-infectious indication
• Willing and able to complete the informed consent process
• Availability for follow-up for the planned duration of the study
• Acceptable medical history by review of inclusion/exclusion criteria

Ki nem vehet részt

• Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
• Life-threatening reactions to previous influenza vaccinations
• Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
• Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
• Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator
• Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol
• Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit (~ 14 days after study vaccination)
• Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 14 days after study enrollment)
• Use of investigational agents within 30 days prior to enrollment or planned use during the study
• Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG
• History of immunodeficiency (including HIV infection)
• Hospitalization in the past year for congestive heart failure or emphysema
• Chronic Hepatitis B or C
• Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia)
• History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
• A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
• Need for allergy immunization (that cannot be postponed) until after the last study visit
• History of Guillain-Barre# syndrome
• Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol
• Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol
• Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit
• Asthma (contraindication for receipt of LAIV4)
• Participants in close contact with anyone who has a severely weakened immune system
• Receipt of blood or blood products within the past 6 months or planned used during the study
• Pregnant or breastfeeding woman