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

Cervical Intraepithelial Neoplasia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01880411
• Other study ID #: HBPEKVPI001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: June 13, 2013
• Last updated: June 14, 2013
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2013
• Source: HealthBanks Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Biological:
• PEK Fusion Protein Vaccine
PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HealthBanks Biotech Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events.		6 Months	Yes