Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein Vaccine
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Number of participants with adverse events. [ Time Frame: 6 Months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01880411
|Principal Investigator:||Christina S Chu, MD||University of Pennsylvania|