Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy men and women ages 18-50 years
Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use)
Willing and able to provide written informed consent
Able to speak and understand English
Women of childbearing potential must have a negative serum pregnancy test.
Influenza vaccination within 6 months prior to screening date
Symptoms of respiratory infection during the 14 days prior to screening
Temperature >38.3o C during the period spanning 72 hours prior to screening and the time of immunization.
History of allergy to egg, influenza vaccine or vaccine ingredients
History of Guillain-Barre syndrome
History of Bell's palsy
Tonsillectomy, adenoidectomy or prior surgery to the paranasal sinus cavity.
Physician diagnosis of or personal history of allergic or chronic rhinitis
Physician diagnosis of or personal history of asthma
Acute sinusitis within 30 days prior to screening
Use of antibiotics within 14 days prior to screening
Requirement for use of nasal corticosteroids for the period beginning 30 days prior to screening through final study visit
Requirement for use of antihistamines (systemic, intranasal or intraocular) for the period beginning 72 hours prior to screening through final study visit
Use of immunomodulating drugs or systemic corticosteroids within 6 months prior to screening (includes but is not limited to azathioprine, methotrexate, mycophenolate mofetil, tumor necrosis factor inhibitors, cyclosporine, tacrolimus)
Past or present history of allergen immunotherapy to within the last 10 years.
Students or employees who are under direct supervision by any of the investigators in this protocol are not eligible to participate.
Subjects who abuse alcohol or illicit substances will be excluded.
Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements.
Other investigational medication use within 30 days of screening.