Table of Contents
ISRN Obstetrics and Gynecology
Volume 2011 (2011), Article ID 292951, 9 pages
http://dx.doi.org/10.5402/2011/292951
Clinical Study

Safety and Immunogenicity of a Human Papillomavirus Peptide Vaccine (CIGB-228) in Women with High-Grade Cervical Intraepithelial Neoplasia: First-in-Human, Proof-of-Concept Trial

1Gyneco-obstetric Hospital Ramon Gonzalez Coro, Havana 10400, Cuba
2Clinical Trials Division, Center for Biological Research, Havana 6996, Cuba
3Gyneco-obstetric Hospital Mariana Grajales, Santa Clara 50100, Cuba
4General Hospital Carlos Manuel de Céspedes, Bayamo 85100, Cuba
5Department of Cancer, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Havana 10600, Cuba
6Department of Genomics, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba

Received 5 January 2011; Accepted 26 January 2011

Academic Editors: R. M. Austin and K. Chan

Copyright © 2011 Ana M. Solares et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. CIGB-228 is a novel therapeutic vaccine consisting of HLA-restricted HPV16 E7 epitope adjuvated with VSSP. This trial was designed to evaluate the toxicity, safety, immunogenicity, HPV clearance, and lesion regression. Methods. Seven women were entered. All were HLA-A2 positive, had biopsy-proven high-grade CIN, histologically positive for HPV16, and beared persistent postbiopsy lesions visible by digital colposcopy. HLA-A2 women with biopsy-proven high-grade CIN, HPV16-positive, and beared persistent postbiopsy lesions visible by digital colposcopy were vaccinated. One weekly injections of CIGB-228 vaccine was given for four weeks. Then, loop electrosurgical excision procedure (LEEP) of the transformation zone was performed. Study subjects were followed for 1 year after LEEP. Results. No toxicity beyond grade 1 was observed during and after the four vaccinations. Five of seven women had complete and partial regression. Cellular immune response was seen in all patients. HPV was cleared in three of the patients with complete response. Conclusion. CIGB-228 vaccination was well tolerated and capable to induce IFN 𝛾 -associated T-cell response in women with high-grade CIN. In several patients, lesion regression and HPV clearance were observed.