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

NCT ID: NCT01880411

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEK Fusion Protein Vaccine

PEK Fusion Protein Vaccine Injection 0.1mg, 0.3mg and 1.2mg One injection at one week intervals

Group Type: EXPERIMENTAL

PEK Fusion Protein Vaccine

Intervention Type: BIOLOGICAL

PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant

Interventions

PEK Fusion Protein Vaccine

PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HealthBanks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina S Chu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Other Identifiers

HBPEKVPI001

Identifier Type: -

Identifier Source: org_study_id