Action Mechanisms and Scientific Rationale of Using Nasal Vaccine (HeberNasvac) for the Treatment of Chronic Hepatitis B

Author:

Aguilar Julio1,Aguiar Jorge1,Akbar Sheikh2ORCID

Affiliation:

1. Hepatitis B Therapeutic Vaccine Project, Center for Genetic Engineering and Biotechnology, La Habana 10600, Cuba

2. Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Matsuyama 791-0295, Japan

Abstract

Nasvac (HeberNasvac®) is a novel therapeutic vaccine for chronic hepatitis B (CHB). This product is a formulation of the core (HBcAg) and surface (HBsAg) antigens of the hepatitis B virus (HBV), administered by nasal and subcutaneous routes, in a distinctive schedule of immunizations. In the present review article, we discuss the action mechanisms of HeberNasvac, considering the immunological properties of the product and their antigens. Specifically, we discuss the capacity of HBcAg to activate different pathways of innate immunity and the signal transduction after a multi-TLR agonist effect, and we review the results of recent clinical trials and in vitro studies. Aimed at understanding the clinical results of Nasvac and other therapeutic vaccines under development, we discuss the rationale of administering a therapeutic vaccine through the nasal route and also the current alternatives to combine therapeutic vaccines and antivirals (NUCs). We also disclose potential applications of this product in novel fields of immunotherapy.

Publisher

MDPI AG

Subject

Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology

Reference51 articles.

1. World Health Organization (2022, October 24). Hepatitis B. Fact Sheet. Available online: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.

2. European Association for the Study of the Liver (2017). EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J. Hepatol., 67, 370–398.

3. Cuban Regulatory Agency (CECMED) (2022, October 24). HeberNasvac: Recombinant Therapeutic Vaccine against the Chronic Infection by the Hepatitis B Virus. Summary of Product Characteristics. Available online: https://www.cecmed.cu/sites/default/files/adjuntos/rcp/biologicos/rcphebernasvac0.pdf.

4. Immune modulator and antiviral potential of dendritic cells pulsed with both hepatitis B surface Ag and core antigen for treating chronic HBV infection;Akbar;Antivir. Ther.,2010

5. In vitro stimulation with HBV therapeutic vaccine candidate Nasvac activates B and T cells from chronic hepatitis B patients and healthy donors;Lobaina;Mol. Immunol.,2015

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