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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Biological: PEK Fusion Protein Vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEK Fusion Protein Vaccine; PEK Fusion Protein Vaccine Injection 0.1mg, 0.3mg and 1.2mg One injection at one week intervals	Biological: PEK Fusion Protein Vaccine; PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events.	6 Months

Collaborators and Investigators

• Sponsor: HealthBanks Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: June 14, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 14, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: PEK fusion protein Healthbanks
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: HBPEKVPI001