The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
Sheikh Mohammad Fazle Akbara✉, Mamun Al Mahtabb, Julio Cesar Aguilarc, Osamu Yoshidaa, Sakirul Khand, Eduardo Pentónc, Guillen Gerardoc, Yoichi Hiasaa
- aDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon 791-0295, Japan
- bDepartment of Hepatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka 1000, Bangladesh
- cCenter for Genetic Engineering and Biotechnology, Havana 10600, Cuba
- dDepartment of Microbiology, Faculty of Medicine, Oita University, Oita 879-5593, Japan
- ✉Corresponding author
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Abstract
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.