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Volume 10
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10.3390/pathogens10111440
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Article

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

by
Sheikh Mohammad Fazle Akbar
1,*,†,
Mamun Al Mahtab
2,†,
Julio Cesar Aguilar
3,†,
Osamu Yoshida
1,
Eduardo Penton
3,
Guillen Nieto Gerardo
3 and
Yoichi Hiasa
1
1
Department of Gastroenterology and Metabology, Graduate School of Medicine, Ehime University, Ehime 791-0295, Japan
2
Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, BSMMU, Dhaka 1000, Bangladesh
3
Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba
*
Author to whom correspondence should be addressed.
†
Authors equal contribution.
Pathogens 2021, 10(11), 1440; https://doi.org/10.3390/pathogens10111440
Submission received: 18 October 2021 / Revised: 3 November 2021 / Accepted: 4 November 2021 / Published: 5 November 2021
(This article belongs to the Collection Emerging and Re-emerging Pathogens)
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Abstract

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.
Keywords: chronic hepatitis B; therapeutic vaccine; sustained effects; nasal vaccine; NASVAC; HBsAg/HBcAg vaccine chronic hepatitis B; therapeutic vaccine; sustained effects; nasal vaccine; NASVAC; HBsAg/HBcAg vaccine

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MDPI and ACS Style

Akbar, S.M.F.; Al Mahtab, M.; Aguilar, J.C.; Yoshida, O.; Penton, E.; Gerardo, G.N.; Hiasa, Y. 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. Pathogens 2021, 10, 1440. https://doi.org/10.3390/pathogens10111440

AMA Style

Akbar SMF, Al Mahtab M, Aguilar JC, Yoshida O, Penton E, Gerardo GN, Hiasa Y. 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. Pathogens. 2021; 10(11):1440. https://doi.org/10.3390/pathogens10111440

Chicago/Turabian Style

Akbar, Sheikh Mohammad Fazle, Mamun Al Mahtab, Julio Cesar Aguilar, Osamu Yoshida, Eduardo Penton, Guillen Nieto Gerardo, and Yoichi Hiasa. 2021. "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" Pathogens 10, no. 11: 1440. https://doi.org/10.3390/pathogens10111440

APA Style

Akbar, S. M. F., Al Mahtab, M., Aguilar, J. C., Yoshida, O., Penton, E., Gerardo, G. N., & Hiasa, Y. (2021). 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. Pathogens, 10(11), 1440. https://doi.org/10.3390/pathogens10111440

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