An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101

Inclusion Criteria:

1. Written informed consent prior to initiation of any study-related procedures;

2. Nonlactating female between the ages of 21 to 65 years, inclusive;

3. Non-childbearing potential (defined as surgically sterile or at least 2 years
postmenopausal) or practicing effective contraception (defined as 2 concurrent methods
of contraception, 1 of which is a barrier method) and agrees to continue using
effective contraception throughout the duration of the study;

4. Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG)
test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit
2 (and at subsequent vaccination visits);

5. Pap test documenting atypical squamous cells of undetermined significance
(ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous
intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL)
within 4 months prior to screening Visit 1;

6. History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy,
within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects
will not be eligible);

7. For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire
lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;

8. Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg,
Hybrid Capture II [Qiagen]);

9. Good health with adequate hematologic, renal, hepatic, and cardiac function, as
determined by the Investigator, based upon medical history, physical examination, and
laboratory test results at the screening visit (Visit 1):

- Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥
100,000/ µL;

- Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);

- Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for
AEs [CTCAE] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0
mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.

- Normal Cardiac function: as assessed by history and physical exam.

Exclusion Criteria:

1. Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on
cervical biopsy;

2. Previous history of cancer, other than adequately treated basal cell or Stage 1
squamous cell carcinoma of the skin;

3. Current recognized immunodeficiency disease, including infection with HIV, cellular
immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or
congenital immunodeficiencies.

4. Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological
response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte
colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior
to administration of the first study vaccination;

5. Serious, concomitant disorder, including active systemic infection requiring
treatment, in the opinion of the investigator;

6. Currently receiving or has received treatment with systemic steroids in the following
dosages within 30 days prior to administration of the first study vaccination.

- Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or
equivalent

- Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent for 2
or more short courses of > 3 days

- Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid
therapy is acceptable;

7. Other condition or prior therapy that, in the opinion of the Investigator, compromises
the subject's welfare or may confound study results;

8. Participation in another investigational study concurrently or use of another
investigational drug within 6 months prior to administration of the first study
vaccination;

9. Previously enrolled in this study.