Safety profile, antiviral capacity, and liver protection of a nasal therapeutic vaccine in patients with chronic hepatitis B: Five-year-follow-up outcomes after the end of treatment

Mamun Al Mahtab; Sheikh Mohammad Fazle Akbar; Julio Cesar Aguilar; Osamu Yoshida; Sakirul Khan; Guillen Nieto Gerardo; Yoichi Hiasa

doi:10.3389/fmed.2023.1032531

Safety profile, antiviral capacity, and liver protection of a nasal therapeutic vaccine in patients with chronic hepatitis B: Five-year-follow-up outcomes after the end of treatment

Front Med (Lausanne). 2023 Feb 8:10:1032531. doi: 10.3389/fmed.2023.1032531. eCollection 2023.

Authors

Mamun Al Mahtab¹, Sheikh Mohammad Fazle Akbar², Julio Cesar Aguilar³, Osamu Yoshida², Sakirul Khan⁴, Guillen Nieto Gerardo³, Yoichi Hiasa²

Affiliations

¹ Department of Hepatology, Interventional Hepatology Division, Bangabandhu Sheikh Mujib Medical University, BSMMU, Dhaka, Bangladesh.
² Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Japan.
³ Center for Genetic Engineering and Biotechnology, Havana, Cuba.
⁴ Department of Microbiology, Faculty of Medicine, Oita University, Oita, Japan.

Abstract

Introduction: There is a pressing need to develop novel drugs for treating patients with chronic hepatitis B (CHB), as commercially available antiviral drugs are endowed with safety and efficacy concerns.

Methods: A phase III clinical trial was conducted with a therapeutic vaccine containing two antigens of the hepatitis B virus (HBV; named NASVAC) in 78 patients with CHB expressing both HBV DNA and elevated levels of alanine aminotransferase (ALT) in the blood. Five years after the end of treatment (EOT), 60 NASVAC-recipient patients were enrolled in this long-term follow-up study to evaluate the safety, antiviral potential, and liver-protective capacity of NASVAC.

Results: NASVAC exhibited an excellent safety profile 5 years after EOT. The levels of HBV DNA in the sera were reduced in 55 of the 60 patients, and 45 of them were negative for HBV DNA in the sera. ALT levels were also normalized in 40 of the 60 patients 5 years after EOT. None of the patients receiving NASVAC developed liver cirrhosis or cancer.

Discussion: The present study is the first to exhibit long-term follow-up data of a finite immune therapy for CHB that is safe and endowed with potent antiviral and liver-protecting capacities.

Keywords: 5-year follow-up; NASVAC; chronic hepatitis B; immune therapy; nasal therapeutic vaccine.