Phase 1 Safety Study of Recombinant Influenza Vaccine for Prevention

This is a multi-center, open-label, dose escalating study in which up to 320 healthy
subjects age 18-40 years will be administered VAX2012Q at one of up to 7 dose levels.
VAX2012Q vaccine will be formulated at the clinical site ("field mix") from the four
components (VAX128C, VAX181, VAX173 and VAX172) in diluent to produce ten doses in a
multi-dose vial for use within 12 hours of preparation. The dose will be prepared from
appropriate dilutions from the monovalent drug product vials. Data for safety and
immunogenicity will be collected after each dose with safety being assessed after each dose
level and immune response, after dose levels 4 and 6. Reactogenicity and safety labs through
Day 1 will be reviewed by the Safety Monitoring Committee (SMC) prior to enrolling in the
next dose level.

Inclusion Criteria:

- Males and females aged 18-40 years of age at the time of vaccination in good health
as determined by medical history, physical exam, laboratory assessments and the
clinical judgment of the Principal Investigator

- Able to provide informed consent indicating that they understand the purpose of this
study and are willing to adhere to the procedures described in this protocol

- If the subject is a female of childbearing potential, she must use adequate
contraceptive precautions (e.g., intrauterine contraceptive device, oral
contraceptives or other equivalent hormonal contraception) for 2 months prior to
vaccination and continue to use such precautions for a minimum of three months after
vaccination. She must also have a negative urine pregnancy test within 24 hours prior
to receiving study vaccine. Women at least one year post-menopausal or surgically
sterile will not be considered of childbearing potential.

- Willing to receive the unlicensed vaccine given as an IM injection

- Willing to provide multiple blood specimens collected by venipuncture

Exclusion Criteria:

- Use of any investigational or non-registered drug or vaccine product within 30 days
preceding the administration of the study vaccine or planned use within the first six
weeks of the study period

- Has received any licensed or other investigational influenza vaccine within 3 months
prior to enrollment in this study or expected receipt of any influenza vaccination
before the Day 21 blood collection

- History of excessive alcohol use, drug abuse or significant psychiatric illness

- Tobacco use within 3 months of enrollment and throughout first 6 months of the study

- Has a chronic illness (e.g., liver or kidney disease), receiving a concomitant
therapy or have any other condition that could interfere with the subject's
participation in the study or in the interpretation of the study results

- Clinically significant abnormal liver function tests at screening

- Positive serology for HBsAg, HCV or HIV antibodies

- Pregnant or lactating female

- 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 minor skin cancers, which are allowed unless located at the
vaccination site

- Persons with impaired immune responsiveness (of any cause), including diabetes
mellitus and autoimmune disorders

- Persons presently receiving or having a recent history of receiving (within the past
six months) 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 (oral or injectable). Inhaled and
topical corticosteroids are allowed.

- Persons with a history of severe allergic reaction after previous vaccinations or
hypersensitivity to any seasonal influenza vaccine component

- Persons with a history of Guillain-Barré Syndrome

- Receipt of blood or blood products 8 weeks prior to vaccination or planned
administration during the three week study period following vaccination

- Donation of blood or blood products within 8 weeks prior to vaccination or during the
three week study period following

- An oral temperature >100.4° or acute disease within 72 hours prior to vaccination,
defined as the presence of a moderate or severe illness (as determined by the
investigator through medical history and physical examination; for example, those
requiring an absence from work) with or without fever.

- Body Mass Index >29.9

- Any disorder of coagulation

- A clinical diagnosis of influenza within the previous 12 months

- Any other condition or circumstance which, in the opinion of the Principal
Investigator, poses an unacceptable risk for participation in the study