A phase I dose-escalation clinical trial of a peptide-based human papillomavirus therapeutic vaccine with candida skin test reagent as a novel vaccine adjuvant for treating women with biopsy-proven cervical intraepithelial neoplasia 2/3.

3032 Background: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. An investigational human papillomavirus (HPV) therapeutic vaccine, PepCan, consists of four current good manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. Methods: The study was a single-arm, single-institution, dose-escalation Phase I clinical trial, and patients with biopsy-proven CIN2/3 were eligible for vaccination. Four injections were administered intradermally every 3 weeks in limbs, and loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects were enrolled at each dose level, and dose escalation was allowed as long as less than two subjects demonstrated dose-limiting toxicities. Results: Six subjects at each of four dose levels (50, 100, 250, and 500 mcg per pepti...