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Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial
Cornelia L Trimble ,
Matthew P Morrow ,
Kimberly A Kraynyak ,
Xuefei Shen ,
Michael Dallas ,
Jian Yan ,
Lance Edwards ,
R Lamar Parker ,
Lynette Denny ,
Mary Giffear ,
Ami Shah Brown ,
Kathleen Marcozzi-Pierce ,
Divya Shah ,
Anna M Slager ,
Albert J Sylvester ,
Amir Khan ,
Kate E Broderick ,
Robert J Juba ,
Timothy A Herring ,
Jean Boyer ,
Jessica Lee ,
Niranjan Y Sardesai ,
David B Weiner ,
Mark L Bagarazzi
November 2015
November 2015
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Abstract
Despite preventive vaccines for oncogenic human papillomaviruses (HPVs), cervical
intraepithelial neoplasia (CIN) is common, and current treatments are ablative and
can lead to long-term reproductive morbidity. We assessed whether VGX-3100, synthetic
plasmids targeting HPV-16 and HPV-18 E6 and E7 proteins, delivered by electroporation,
would cause histopathological regression in women with CIN2/3.