A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GI-13020 at Various Dose Levels and Regimens in Healthy Adults.

HBV specific T cell responses have been shown to have a positive association with infection
status in patients with chronic HBV, with the weakest T cell responses in patients with
untreated chronic active infection and the strongest T cell responses in patients who have
achieved seroconversion or cure (4). We have generated a Tarmogen expressing well conserved
regions of the HBV X, S, and core antigens (GI-13020). GI-13020 is immunogenic in murine
models and has also been used to stimulate human immune cell samples ex vivo to elicit HBV
specific T cell responses which could predict the immune responses in patients dosed with
GI-13020. GI-13020 will be evaluated in this healthy volunteer study to assess its safety,
tolerability, and ability to elicit HBV specific T cell responses. In the future GI-13020
could be used in combination with HBV antivirals, such as tenofovir disoproxil fumarate, in
an attempt to improve HBsAg seroconversion (cure) rates in patients with chronic HBV
infection.

Inclusion Criteria:

- Signed, written, informed consent from the subject before any study-specific
procedures are performed.

- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.

- If female, negative pregnancy test and for women of childbearing potential
willingness to use reliable method of birth control during the study and for 30 days
after the last dose of study medication (see section 8.1.3 for required birth
control).

- Male or female aged ≥ 18 years at the time of first dose.

- Negative scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.

Exclusion Criteria:

- Hospitalization in the last 6 months.

- No medicine adjustments in the last 6 months.

- History of anaphylaxis from any cause.

- History of HBV infection as evidenced by detection of HBV Surface and Core antigens.

- History of vaccination with HBV prophylactic vaccine or positive for antibody to HBV
Surface and Core.

- Known exposure to HBV within the past 6 weeks.

- Increased AFP at screening.

- History of HCV infection or positive HCV antibody, Herpes zoster, shingles or any
other chronic viral infection.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.

- Known history of human immunodeficiency virus (HIV) infection or positive HIV
antibody test at screening.

- History of demyelinating disease such as Guillain-Barre Syndrome.

- History of Bell's Palsy.

- Immunosuppression as a result of underlying illness or treatment.

- History of cancer within the last 5 years with the exception of localized basal or
squamous cell carcinoma or Stage 1A cervical cancer.

- History of Crohn's disease or ulcerative colitis.

- History of autoimmune disease.

- History of organ transplantation.

- Concurrent and chronic therapy with immunosuppressive drugs including systemic
corticosteroids.

- Receipt of investigational drugs or vaccines within 30 days or 5 half lives,
whichever is longer, prior to first injection with the study drug.

- Receipt of immunoglobulin or other blood products within 3 months prior to
enrollment.

- Receipt of allergy shots within the preceding 7 days or expected to receive allergy
shots during the study and 7 days following completion of study.

- Receipt of biologics.

- Negative histamine response on scratch test at screening.

- High risk for noncompliance with the protocol.

- Alcohol and/or IV drug abuse within the past year.

- Positive urine drug test at screen visit.