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
Joint Authors
Ferrer, Annia
Torrens, Isis
Fanjull, Sonia
Ramos, Thelvia
Gonzalez, Leonardo
Baladron, Idania
Borbon, Zaida
Granadillo, Milaid
Solares, Ana M.
Batte, Aileen
Ale, Mayte
Castillo, Dagnelia
Lopez-Saura, Pedro
Valenzuela, Carmen
Cintado, Alberto
Fernandez de Cossio, Maria E.
Esmir, Julio
Source
ISRN Obstetrics and Gynecology
Issue
Vol. 2011, Issue 2011 (31 Dec. 2011), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-03-24
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Solares, Ana M.& Baladron, Idania& Ramos, Thelvia& Valenzuela, Carmen& Borbon, Zaida& Fanjull, Sonia…[et al.]. 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،Vol. 2011, no. 2011, pp.1-9.
https://search.emarefa.net/detail/BIM-461000
Modern Language Association (MLA)
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 No. 2011 (2011), pp.1-9.
https://search.emarefa.net/detail/BIM-461000
American Medical Association (AMA)
Solares, Ana M.& Baladron, Idania& Ramos, Thelvia& Valenzuela, Carmen& Borbon, Zaida& Fanjull, Sonia…[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. 2011. Vol. 2011, no. 2011, pp.1-9.
https://search.emarefa.net/detail/BIM-461000
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-461000