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Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac
A novel therapeutic vaccine for chronic hepatitis B (CHB) treatment comprising the recombinant hepatitis B surface (HBsAg) and nucleocapsid (HBcAg) antigens has been developed. Preclinical and clinical trials (CT) evidenced safety and immunogenicity in animal models as well as in phases I, II, and I...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Jaypee Brothers Medical Publishers
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6395482/ https://www.ncbi.nlm.nih.gov/pubmed/30828555 http://dx.doi.org/10.5005/jp-journals-10018-1279 |
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author | Fernández, Guillermo L Sanchez, Ana Jerez, Everardo E Anillo, Luis Freyre, Freya A Aguiar, Jorge Leon, Yamila Cinza, Zurina A Diaz, Pablo Figueroa, Nelvis Muzio, Verena G Nieto, Gerardo Lobaina, Yadira Aguilar, Arístides Penton, Eduardo C Aguilar, Julio |
author_facet | Fernández, Guillermo L Sanchez, Ana Jerez, Everardo E Anillo, Luis Freyre, Freya A Aguiar, Jorge Leon, Yamila Cinza, Zurina A Diaz, Pablo Figueroa, Nelvis Muzio, Verena G Nieto, Gerardo Lobaina, Yadira Aguilar, Arístides Penton, Eduardo C Aguilar, Julio |
author_sort | Fernández, Guillermo |
collection | PubMed |
description | A novel therapeutic vaccine for chronic hepatitis B (CHB) treatment comprising the recombinant hepatitis B surface (HBsAg) and nucleocapsid (HBcAg) antigens has been developed. Preclinical and clinical trials (CT) evidenced safety and immunogenicity in animal models as well as in phases I, II, and III clinical trials. A phase I CT has conducted in Cuba in 6 CHB patients refractory or incomplete responders to α-IFN. Patients were immunized ten times every two weeks via. nasal spray, with 100 ug HBsAg and 100 ug HBcAg. Clinical efficacy was monitored by assessing the levels of hepatitis B virus deoxyribonucleic acid (HBV DNA), alanine aminotransferase (ALT), HBeAg, and anti-HBeAg seroconversion as well as by qualitative/ quantitative HBsAg serology during this period. After a 5 year follow-up,HBeAg loss was verified in the three HBeAg (+) patients, in two cases with seroconversion to anti-HBeAg. A reduction to undetectable viral load was observed in 5 out of 6 patients, and in two cases HBsAg seroconversion was also detected. ALT increases above the 2X upper limit of normal (ULN) were only detected in HBeAg (+) patients and associated with HBe antigen loss. All patients had stiffness levels below 7.8 KPa by Fibroscan assessment at the end of this period. Although only a few patients were enrolled in this study, it seems that HeberNasvac may maintain some of the therapeutic effects for a prolonged period. How to cite this article: Fernandez G, Sanchez AL, Jerez E, Anillo LE, Freyre F, Aguiar JA, Leon Y, Cinza Z, Diaz PA, Figueroa N, Muzio V, Nieto GG, Lobaina Y, Aguilar A, Penton E, Aguilar JC. Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac. Euroasian J Hepatogastroenterol, 2018;8(2):133-139. |
format | Online Article Text |
id | pubmed-6395482 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Jaypee Brothers Medical Publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-63954822019-03-01 Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac Fernández, Guillermo L Sanchez, Ana Jerez, Everardo E Anillo, Luis Freyre, Freya A Aguiar, Jorge Leon, Yamila Cinza, Zurina A Diaz, Pablo Figueroa, Nelvis Muzio, Verena G Nieto, Gerardo Lobaina, Yadira Aguilar, Arístides Penton, Eduardo C Aguilar, Julio Euroasian J Hepatogastroenterol Research Article A novel therapeutic vaccine for chronic hepatitis B (CHB) treatment comprising the recombinant hepatitis B surface (HBsAg) and nucleocapsid (HBcAg) antigens has been developed. Preclinical and clinical trials (CT) evidenced safety and immunogenicity in animal models as well as in phases I, II, and III clinical trials. A phase I CT has conducted in Cuba in 6 CHB patients refractory or incomplete responders to α-IFN. Patients were immunized ten times every two weeks via. nasal spray, with 100 ug HBsAg and 100 ug HBcAg. Clinical efficacy was monitored by assessing the levels of hepatitis B virus deoxyribonucleic acid (HBV DNA), alanine aminotransferase (ALT), HBeAg, and anti-HBeAg seroconversion as well as by qualitative/ quantitative HBsAg serology during this period. After a 5 year follow-up,HBeAg loss was verified in the three HBeAg (+) patients, in two cases with seroconversion to anti-HBeAg. A reduction to undetectable viral load was observed in 5 out of 6 patients, and in two cases HBsAg seroconversion was also detected. ALT increases above the 2X upper limit of normal (ULN) were only detected in HBeAg (+) patients and associated with HBe antigen loss. All patients had stiffness levels below 7.8 KPa by Fibroscan assessment at the end of this period. Although only a few patients were enrolled in this study, it seems that HeberNasvac may maintain some of the therapeutic effects for a prolonged period. How to cite this article: Fernandez G, Sanchez AL, Jerez E, Anillo LE, Freyre F, Aguiar JA, Leon Y, Cinza Z, Diaz PA, Figueroa N, Muzio V, Nieto GG, Lobaina Y, Aguilar A, Penton E, Aguilar JC. Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac. Euroasian J Hepatogastroenterol, 2018;8(2):133-139. Jaypee Brothers Medical Publishers 2018 2019-02-01 /pmc/articles/PMC6395482/ /pubmed/30828555 http://dx.doi.org/10.5005/jp-journals-10018-1279 Text en Copyright © 2018; Jaypee Brothers Medical Publishers (P) Ltd. This work is licensed under a Creative Commons Attribution 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/3.0/ |
spellingShingle | Research Article Fernández, Guillermo L Sanchez, Ana Jerez, Everardo E Anillo, Luis Freyre, Freya A Aguiar, Jorge Leon, Yamila Cinza, Zurina A Diaz, Pablo Figueroa, Nelvis Muzio, Verena G Nieto, Gerardo Lobaina, Yadira Aguilar, Arístides Penton, Eduardo C Aguilar, Julio Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac |
title | Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac |
title_full | Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac |
title_fullStr | Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac |
title_full_unstemmed | Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac |
title_short | Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac |
title_sort | five-year follow-up of chronic hepatitis b patients immunized by nasal route with the therapeutic vaccine hebernasvac |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6395482/ https://www.ncbi.nlm.nih.gov/pubmed/30828555 http://dx.doi.org/10.5005/jp-journals-10018-1279 |
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