H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers

Inclusion Criteria:

- Males and females 18 to 49 years of age.

- Must be in good general health as confirmed by a medical history and physical exam,
vital signs, and screening laboratories conducted no more than 30 days prior to study
injection administration.

- Female subjects of childbearing potential, regardless of birth control history, must
have a negative serum pregnancy test at screening, a negative urine pregnancy test on
the day of each study injection, must not be breast-feeding or lactating, and are
required to consistently use one of the following methods of contraception through
the first three months of the study: hormonal (e.g. oral, transdermal, intravaginal,
implant, or injection); double barrier (i.e., condom, diaphragm with spermicide);
intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum);
abstinence (as confirmed by the investigator); or bilateral tubal ligation (if no
conception post-procedure). These precautions are necessary due to unknown effects
that H5-VLP + GLA AF or H5-VLP alone might have in a fetus or newborn infant. The
subject must have no plan to become pregnant during the first three months of the
study period. Females who are post-menopausal (no spotting at all) for at least one
(1) year will not require a pregnancy test.

- The following screening laboratory blood tests must have values within the normal
ranges (as provided by each clinical site) or not clinically significant as
determined by the Principal Investigator (or designated sub-investigator) and Medical
Monitor (all test results must be within 30 days prior to first study injection):
sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine,
fasting glucose, fasting lipid panel, total WBC count, hemoglobin, and platelet
count.

- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface
antigen (HBsAg), and hepatitis C virus (HCV) antibody.

- Negative urine test for recreational drugs and alcohol per Clinical Research Unit
standards.

- Urinalysis not clinically significant as determined by the study clinician.

- In the opinion of the Investigator, must show comprehension of the study
requirements, competence and willingness to provide written, informed consent for
participation after reading the informed consent form. The subject must have adequate
opportunity to discuss the study with an Investigator or qualified designee.

- Must be capable of completing a study memory aid in English.

- Must be able and willing to attend all evaluation visits, be reachable by telephone
on a consistent basis by the study site personnel, and have a permanent address.

Exclusion Criteria:

- Previous exposure to H5N1 vaccines or experimental products containing GLA-AF.

- History of allergy to any of the constituents of H5-VLP (H5N1) + Alhydrogel (aluminum
hydroxide) vaccine.

- Participation in another experimental protocol or receipt of any investigational or
non-registered products within the past 3 months or planned use during the study
period. Subjects may not participate in any other drug study while participating in
this study.

- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as
prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy
drugs or radiation) within the past 6 months.

- Received a blood transfusion or immunoglobulin within the past 3 months.

- Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month.

- Poor venous access.

- Administration of any vaccine (including any other influenza vaccine) within a 30 day
period prior to study enrollment, or planned administration of any vaccines within
the period from the first study injection up to blood sampling at Day 42 or within 30
days prior to blood sampling at Day 189. 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 injection
administration. Receipt of any other emergency immunizations (e.g. rabies) will
result in a case-by-case review of continued participation.

- History of autoimmune disease or other causes of immunosuppressive states.

- Any confirmed or suspected immunosuppressive condition or immunodeficiency including
history of human immunodeficiency virus (HIV) infection or presence of
lymphoproliferative disease.

- History or evidence of any acute or chronic illness (including cardiovascular,
pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, or renal
disorders, controlled hypertension), or use of medication that, in the opinion of the
Principal Investigator (or designated sub-investigator), may interfere with the
evaluation of the safety or immunogenicity of the vaccine.

- Cancer or treatment for cancer within 3 years of study injection 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.

- Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric
illness. "Uncontrolled" is defined as:

- Requiring a new medical or surgical treatment within one month prior to study
vaccine administration

- Requiring a change in medication dosage in one month prior to test article
administration due to uncontrolled symptoms or drug toxicity (elective dosage
adjustments in stable subjects are acceptable), or

- Hospitalization or an event fulfilling the definition of a serious adverse event
within one month prior to test article administration

- Rash, tattoos or any other dermatological condition that could adversely affect the
vaccine injection site or interfere with its evaluation.

- BMI <18 or >30 kg/m2.

- Hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg).

- Resting pulse rate <40 bpm or >100 bpm.

- Any medical or neuropsychiatric condition which, in the Investigator's opinion, would
render the subject incompetent to provide informed consent or unable to provide valid
safety observations and reporting.

- Known or suspected alcohol or drug abuse within the past 6 months.

- Chronic smoker (> 20 pack years).

- History of allergy to tobacco or eggs.

- Subjects with a history of previous anaphylaxis or severe allergic reaction to
vaccines, or unknown allergens.

- Subjects who are unlikely to cooperate with the requirements of the study protocol.