NCT01880411

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: HealthBanks Biotech Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	PEK Fusion Protein Vaccine	PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-01-01
• Completion: 2014-06-01
• First posted: 2013-06-19
• Last updated: 2013-06-19