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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.
Details
| Lead sponsor | HealthBanks Biotech Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 15 |
| Start date | 2013-06 |
| Completion | 2014-06 |
Conditions
- Cervical Intraepithelial Neoplasia
Interventions
- PEK Fusion Protein Vaccine
Primary outcomes
- Number of participants with adverse events. — 6 Months