Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial

A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks af...

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Autores principales:	Sheikh Mohammad Fazle Akbar, Mamun Al Mahtab, Julio Cesar Aguilar, Osamu Yoshida, Eduardo Penton, Guillen Nieto Gerardo, Yoichi Hiasa
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	chronic hepatitis B therapeutic vaccine sustained effects nasal vaccine NASVAC HBsAg/HBcAg vaccine Medicine R
Acceso en línea:	https://doaj.org/article/2121e5c663214e4da03bd2d7a3be6939
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spelling	oai:doaj.org-article:2121e5c663214e4da03bd2d7a3be69392021-11-25T18:38:16ZSustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial10.3390/pathogens101114402076-0817https://doaj.org/article/2121e5c663214e4da03bd2d7a3be69392021-11-01T00:00:00Zhttps://www.mdpi.com/2076-0817/10/11/1440https://doaj.org/toc/2076-0817A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA, alanine aminotransferase (ALT), and hepatitis B e antigen (HBeAg). The data reveal that 33 of 66 NASVAC-recipient CHB patients became negative for HBV DNA in the blood two years after EOT. The ALT levels were within the upper limit of normal (ULN) in 37 patients, although all 66 CHB patients had elevated ALT (above ULN) before the start of therapy. Out of the total twelve HBeAg-positive patients, eight patients became negative for HBeAg. None of the patients developed cirrhosis of the liver within this period. NASVAC is a finite treatment regimen with sustained antiviral and liver-protecting properties. This study is the first to report follow-up data of immune therapy for CHB. NASVAC, an immune therapy of finite duration, is endowed with sustained antiviral and liver protection properties in CHB patients.Sheikh Mohammad Fazle AkbarMamun Al MahtabJulio Cesar AguilarOsamu YoshidaEduardo PentonGuillen Nieto GerardoYoichi HiasaMDPI AGarticlechronic hepatitis Btherapeutic vaccinesustained effectsnasal vaccineNASVACHBsAg/HBcAg vaccineMedicineRENPathogens, Vol 10, Iss 1440, p 1440 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	chronic hepatitis B therapeutic vaccine sustained effects nasal vaccine NASVAC HBsAg/HBcAg vaccine Medicine R
spellingShingle	chronic hepatitis B therapeutic vaccine sustained effects nasal vaccine NASVAC HBsAg/HBcAg vaccine Medicine R Sheikh Mohammad Fazle Akbar Mamun Al Mahtab Julio Cesar Aguilar Osamu Yoshida Eduardo Penton Guillen Nieto Gerardo Yoichi Hiasa Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
description	A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA, alanine aminotransferase (ALT), and hepatitis B e antigen (HBeAg). The data reveal that 33 of 66 NASVAC-recipient CHB patients became negative for HBV DNA in the blood two years after EOT. The ALT levels were within the upper limit of normal (ULN) in 37 patients, although all 66 CHB patients had elevated ALT (above ULN) before the start of therapy. Out of the total twelve HBeAg-positive patients, eight patients became negative for HBeAg. None of the patients developed cirrhosis of the liver within this period. NASVAC is a finite treatment regimen with sustained antiviral and liver-protecting properties. This study is the first to report follow-up data of immune therapy for CHB. NASVAC, an immune therapy of finite duration, is endowed with sustained antiviral and liver protection properties in CHB patients.
format	article
author	Sheikh Mohammad Fazle Akbar Mamun Al Mahtab Julio Cesar Aguilar Osamu Yoshida Eduardo Penton Guillen Nieto Gerardo Yoichi Hiasa
author_facet	Sheikh Mohammad Fazle Akbar Mamun Al Mahtab Julio Cesar Aguilar Osamu Yoshida Eduardo Penton Guillen Nieto Gerardo Yoichi Hiasa
author_sort	Sheikh Mohammad Fazle Akbar
title	Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
title_short	Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
title_full	Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
title_fullStr	Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
title_full_unstemmed	Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
title_sort	sustained antiviral and liver protection by a nasal therapeutic vaccine (nasvac, containing both hbsag and hbcag) in patients with chronic hepatitis b: 2-year follow-up of phase iii clinical trial
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/2121e5c663214e4da03bd2d7a3be6939
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Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial

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