Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49

INCLUSION

• Male or female aged 18 - 49 years
• Give written informed consent
• Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
• Females should not be pregnant and not lactating and fulfill one of the following criteria: At least one year post-menopausal;Surgically sterile;Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after vaccination
• Willing to use another reliable form of contraception approved by the Investigator for study duration and until 28 days after vaccination.
• Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits
• Willing to receive the unlicensed (VAX161) vaccine given as an i.m. injection.
• Willing to provide multiple blood specimens collected by venipuncture.

EXCLUSION

• Persons who have a psychiatric illness, a chronic illness, or who are taking a concomitant therapy or have any other condition that would interfere with the subject's participation in the study or interpretation of the study results.
• Persons with clinically significant abnormal liver function tests at screening.
• Positive serology for HBsAg, HCV or HIV antibodies.
• Persons having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
• Persons with impaired immune responsiveness, including diabetes mellitus.
• Persons presently receiving or having a recent history of receiving any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids.
• Persons who have received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during 42 day study period following vaccination, including licensed influenza vaccines.
• history of anaphylactic type reaction to injected vaccines.
• history of drug or chemical abuse in the year prior to screening.
• history of Guillain-Barré Syndrome.
• have received, or plan to receive, any investigational product or non-registered drug within 30 days prior to vaccination and during the 42 day study period after vaccination.
• Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the 42 day study period following vaccination.
• Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.
• Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever, or a fever > 100.4° F orally.
• significant cardiovascular disease e.g., New York Heart Association (NYHA) Class 3 or 4 congestive heart failure; myocardial infarction within the past six months; unstable angina, coronary angioplasty within the past six months; uncontrolled ventricular cardiac arrhythmias; resting heart rate (HR) >100 beats per minute (bpm).
• history of chronic obstructive pulmonary disease or history of other lung disease.
• Any condition that, in the opinion of the investigator, might interfere with study objectives.
• Previously received an H5 or avian influenza vaccine, including VAX161.
• Persons with a BMI ≥40