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The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial

The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten...

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Autores principales: Akbar, Sheikh Mohammad Fazle, Al Mahtab, Mamun, Aguilar, Julio Cesar, Yoshida, Osamu, Khan, Sakirul, Penton, Eduardo, Gerardo, Guillen Nieto, Hiasa, Yoichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8778341/
https://www.ncbi.nlm.nih.gov/pubmed/35062707
http://dx.doi.org/10.3390/vaccines10010045
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author Akbar, Sheikh Mohammad Fazle
Al Mahtab, Mamun
Aguilar, Julio Cesar
Yoshida, Osamu
Khan, Sakirul
Penton, Eduardo
Gerardo, Guillen Nieto
Hiasa, Yoichi
author_facet Akbar, Sheikh Mohammad Fazle
Al Mahtab, Mamun
Aguilar, Julio Cesar
Yoshida, Osamu
Khan, Sakirul
Penton, Eduardo
Gerardo, Guillen Nieto
Hiasa, Yoichi
author_sort Akbar, Sheikh Mohammad Fazle
collection PubMed
description The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcutaneous injection. A total of 59 patients with CHB were enrolled. Adverse events were not seen in any of the patients. Out of the 59 CHB patients, 54 patients exhibited a reduction in HBV DNA, compared with their basal levels. Although all the patients had alanine transaminase (ALT) above the upper limit of normal (>42 IU/L) before the commencement of therapy, the levels of ALT were within the ULN level in 42 patients. No patient developed cirrhosis of the liver. The present study, showing the safety and efficacy of NASVAC 3 years after the EOT, is the first to report follow-up data of an immune therapeutic agent against CHB. NASVAC represents a unique drug against CHB that is safe, of finite duration, can be administered by the nasal route, is capable of reducing HBV DNA and normalizing ALT, and contains hepatic fibrosis.
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spelling pubmed-87783412022-01-22 The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial Akbar, Sheikh Mohammad Fazle Al Mahtab, Mamun Aguilar, Julio Cesar Yoshida, Osamu Khan, Sakirul Penton, Eduardo Gerardo, Guillen Nieto Hiasa, Yoichi Vaccines (Basel) Article The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcutaneous injection. A total of 59 patients with CHB were enrolled. Adverse events were not seen in any of the patients. Out of the 59 CHB patients, 54 patients exhibited a reduction in HBV DNA, compared with their basal levels. Although all the patients had alanine transaminase (ALT) above the upper limit of normal (>42 IU/L) before the commencement of therapy, the levels of ALT were within the ULN level in 42 patients. No patient developed cirrhosis of the liver. The present study, showing the safety and efficacy of NASVAC 3 years after the EOT, is the first to report follow-up data of an immune therapeutic agent against CHB. NASVAC represents a unique drug against CHB that is safe, of finite duration, can be administered by the nasal route, is capable of reducing HBV DNA and normalizing ALT, and contains hepatic fibrosis. MDPI 2021-12-30 /pmc/articles/PMC8778341/ /pubmed/35062707 http://dx.doi.org/10.3390/vaccines10010045 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Akbar, Sheikh Mohammad Fazle
Al Mahtab, Mamun
Aguilar, Julio Cesar
Yoshida, Osamu
Khan, Sakirul
Penton, Eduardo
Gerardo, Guillen Nieto
Hiasa, Yoichi
The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
title The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
title_full The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
title_fullStr The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
title_full_unstemmed The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
title_short The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
title_sort safety and efficacy of a therapeutic vaccine for chronic hepatitis b: a follow-up study of phase iii clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8778341/
https://www.ncbi.nlm.nih.gov/pubmed/35062707
http://dx.doi.org/10.3390/vaccines10010045
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