Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine (PEK + GPI-0100) in Patients With LSIL or HSIL
Inclusion Criteria:
- Female age 18 to 45 years
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- LSIL or HSIL on Papanicolaou (PAP) smear within the prior 6-8 weeks
- Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count)
and urinalysis, as judged by Grade 0-1 as per National Cancer Institute Common
Toxicity Criteria (NCI-CTC) performed up to 30 days prior to administration of study
treatment.
- Body mass index (BMI) ≤32 kg/m2
- Women of child-bearing potential (WOCBP) agree to use two forms of medically
effective contraception (e.g. hormonal contraception, intrauterine device, barrier
method, spermicide, etc…) during the study and for at least 12 weeks following the
completion of treatment. Patients agree to inform the investigator immediately if
they become pregnant during the study or within 12 weeks following completion of
treatment and to provide information about the pregnancy, delivery and health of the
infant until the age of one month.
- Able and willing to comply with all study procedures
Exclusion Criteria:
- Active infection with herpes simplex virus (HSV)
- Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus
(HCV), or Hepatitis B surface antigen (HBsa)
- Pregnant or breast-feeding
- History of any prior cervical surgical treatment
- History of any active autoimmune disease or current medical condition requiring the
use of systemic or topical corticosteroids (excluding steroid containing eye drops or
inhaled steroids) or other immunosuppressive agents within 4 weeks prior to
enrollment
- History of cancer (excluding basal cell carcinoma of the skin)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Administration of any blood product within 3 months of enrollment
- Administration of any vaccine within 6 weeks of enrollment
- Active infection requiring antimicrobial treatment
- Participation in any study with an investigational compound or device within 30 days
prior to signing informed consent
- Any hematologic disorder involving platelets or clotting abnormalities or any
condition requiring treatment with transfusions, anticoagulants or platelet
inhibitors
- Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study protocol
- Any condition which, in the opinion of the investigator, would limit the evaluation
of the patient.