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Solares AM, Baladron I, Ramos T, et al. 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. ISRN Obstet Gynecol. 2011;2011:292951doi: 10.5402/2011/292951.
Solares, A. M., Baladron, I., Ramos, T., Valenzuela, C., Borbon, Z., Fanjull, S., Gonzalez, L., Castillo, D., Esmir, J., Granadillo, M., Batte, A., Cintado, A., Ale, M., Fernandez de Cossio, M. E., Ferrer, A., Torrens, I., & Lopez-Saura, P. (2011). 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. ISRN obstetrics and gynecology, 2011292951. https://doi.org/10.5402/2011/292951
Solares, Ana M, et al. "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." ISRN obstetrics and gynecology vol. 2011 (2011): 292951. doi: https://doi.org/10.5402/2011/292951
Solares AM, Baladron I, Ramos T, Valenzuela C, Borbon Z, Fanjull S, Gonzalez L, Castillo D, Esmir J, Granadillo M, Batte A, Cintado A, Ale M, Fernandez de Cossio ME, Ferrer A, Torrens I, Lopez-Saura P. 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. ISRN Obstet Gynecol. 2011;2011:292951. doi: 10.5402/2011/292951. Epub 2011 Mar 24. PMID: 21748025; PMCID: PMC3118643.
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ISRN Obstet Gynecol. 2011;2011:292951. doi: 10.5402/2011/292951. Epub 2011 Mar 24.

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.

ISRN obstetrics and gynecology

Ana M Solares, Idania Baladron, Thelvia Ramos, Carmen Valenzuela, Zaida Borbon, Sonia Fanjull, Leonardo Gonzalez, Dagnelia Castillo, Julio Esmir, Milaid Granadillo, Aileen Batte, Alberto Cintado, Mayte Ale, Maria E Fernandez de Cossio, Annia Ferrer, Isis Torrens, Pedro Lopez-Saura

Affiliations

  1. Gyneco-obstetric Hospital Ramon Gonzalez Coro, Havana 10400, Cuba.

PMID: 21748025 PMCID: PMC3118643 DOI: 10.5402/2011/292951

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 IFNγ-associated T-cell response in women with high-grade CIN. In several patients, lesion regression and HPV clearance were observed.

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