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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01880411
Recruitment Status : Unknown
Verified June 2013 by HealthBanks Biotech Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
HealthBanks Biotech Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Biological: PEK Fusion Protein Vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Number of participants with adverse events. [ Time Frame: 6 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01880411

Sponsors and Collaborators
HealthBanks Biotech Co., Ltd.
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Principal Investigator: Christina S Chu, MD University of Pennsylvania

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Responsible Party: HealthBanks Biotech Co., Ltd. Identifier: NCT01880411    
Other Study ID Numbers: HBPEKVPI001
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by HealthBanks Biotech Co., Ltd.:
PEK fusion protein Healthbanks
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs