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

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Brief Title

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

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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of participants with adverse events.


Condition

Cervical Intraepithelial Neoplasia

Intervention

PEK Fusion Protein Vaccine

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

15

Start Date

June 2013

Completion Date

June 2014

Primary Completion Date

January 2014

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.
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Christina S Chu, MD, , 



Administrative Informations


NCT ID

NCT01880411

Organization ID

HBPEKVPI001


Responsible Party

Sponsor

Study Sponsor

HealthBanks Biotech Co., Ltd.


Study Sponsor

Christina S Chu, MD, Principal Investigator, University of Pennsylvania


Verification Date

June 2013