title: 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.
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.
authors: Gyneco-obstetric Hospital Ramon Gonzalez Coro, Havana 10400, Cuba.
authors: Ana M
authors: AM
authors: Solares
authors: Idania
authors: I
authors: Baladron
authors: Thelvia
authors: T
authors: Ramos
authors: Carmen
authors: C
authors: Valenzuela
authors: Zaida
authors: Z
authors: Borbon
authors: Sonia
authors: S
authors: Fanjull
authors: Leonardo
authors: L
authors: Gonzalez
authors: Dagnelia
authors: D
authors: Castillo
authors: Julio
authors: J
authors: Esmir
authors: Milaid
authors: M
authors: Granadillo
authors: Aileen
authors: A
authors: Batte
authors: Alberto
authors: A
authors: Cintado
authors: Mayte
authors: M
authors: Ale
authors: Maria E
authors: ME
authors: Fernandez de Cossio
authors: Annia
authors: A
authors: Ferrer
authors: Isis
authors: I
authors: Torrens
authors: Pedro
authors: P
authors: Lopez-Saura