Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein Vaccine

HealthBanks Biotech

Status and phase

Unknown

Phase 1

Conditions

Cervical Intraepithelial Neoplasia

Treatments

Biological: PEK Fusion Protein Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01880411

HBPEKVPI001

Details and patient eligibility

About

Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.

PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response.

Enrollment

15 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.