Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults

Exclusion Criteria

• •Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
• •1. Requiring a new medical or surgical treatment within one month prior to study vaccine administration;
• •2. Requiring a change in medication dosage in one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
• •3. Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to study vaccine administration;
• •* Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting;
• •* Any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease;
• •* Presence of any febrile illness, oral temperature of \> 38.0˚C (100.4˚F) within 24 hours prior to randomization. Such subjects may be re-evaluated for randomization after resolution of illness;
• •* History of autoimmune disease;
• •* Administration of any vaccine (including any other influenza vaccine) within a 30 day period prior to study enrollment, or planned administration within the period from the first vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis of a tetanus and diphtheria toxoids adsorbed for adult use (Td) will be allowed provided the vaccine is not administered within two weeks prior to study vaccine administration. Receipt of any other emergency immunizations (e.g. rabies) will result in a case-by-case review by the medical monitor of continued participation;
• •* Use of any investigational or non-marketed product within 30 days prior to study enrollment or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study;
• •* Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of first study vaccine administration, or any other cytotoxic or immunosuppressant drug within three months of vaccination.
• •* Use of any immune globulin product
• •* Use of high dose inhaled steroids or oral and parenteral high dose steroid medications. Nasal steroids are allowed. Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin \[eg\</= 325 mg/day (1 regular adult aspirin) or \</= 81 mg/day (1 baby aspirin)\], and without a clinically apparent bleeding tendency are eligible;
• •* History of allergy to any of the constituents of H1 VLP (H1N1) study vaccine, or the phosphate buffer;
• •* History of allergy to egg-based vaccines such as allergy or hypersensitivity to egg proteins.
• •* History of severe allergic reactions or anaphylaxis or severe asthma;
• •* History of tobacco allergy;
• •* History of anti-histaminics used continuously for 4 weeks or more at any time in the past year, prior to randomization;
• •* Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
• •* Have received a blood transfusion within 90 days prior to vaccination;
• •* If female, either known pregnancy or urine beta-human chorionic gonadotropin (ß-hCG) test results consistent with pregnancy during the screening period and prior to study vaccine administration on Day 0;
• •* Female subjects who are lactating;
• •* Any vital sign abnormalities: systolic blood pressure, diastolic blood pressure, resting pulse rate or not well controlled and according to the Investigator's opinion;
• •* Cancer or treatment for cancer within 3 years of study vaccine administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible.
• •* Subject with a history of Gillian Barre Syndrome