Abstract
Meeting abstracts The Phase II study, designated HPV-003 ([NCT01304524][1]), assessed the safety and efficacy of VGX-3100 in 167 women with biopsy-proven cervical intraepithelial neoplasia (CIN) 2 or CIN 3 and HPV-16 or -18. The randomized, placebo-controlled, double-blind study, was stratified by
Highlights
The Phase II study, designated HPV-003 (NCT01304524), assessed the safety and efficacy of VGX-3100 in 167 women with biopsy-proven cervical intraepithelial neoplasia (CIN) 2 or CIN 3 and HPV-16 or -18
The randomized, placebo-controlled, double-blind study, was stratified by age and severity of CIN and evaluated cervical tissue changes after three 6 mg intramuscular doses of the DNA vaccine VGX-3100 followed by electroporation (EP) with Inovio’s CELLECTRA® 2000 device at weeks 0, 4, and 12
Cervical tissue was examined before starting blinded treatment and ~9 months later
Summary
The Phase II study, designated HPV-003 (NCT01304524), assessed the safety and efficacy of VGX-3100 in 167 women with biopsy-proven cervical intraepithelial neoplasia (CIN) 2 or CIN 3 and HPV-16 or -18. DNA vaccine VGX-3100 with electroporation induces regression of cervical intraepithelial neoplasia 2/3 and clears HPV infection with robust T cell responses: results of a randomized, double-blind, placebo-controlled Phase II trial From Society for Immunotherapy of Cancer 29th Annual Meeting National Harbor, MD, USA.
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