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Peer-reviewedCC BY 4.0Advanced Pharmaceutical Bulletin

Chemical Design and Therapeutic Efficacy of HBsAg-Based Nanovaccines for Hepatitis B Virus Clearance: A Preclinical and Clinical Systematic Review

  • Hasti Nequi Marnani1
  • Tahereh Zadeh Mehrizi2
  • Babak Eshrati3
  • Mehdi Shafiee Ardestani1,4
  • Nazanin Ajdary5
  • Mohammad Vodjgani6
  • Nariman Mosaffa7
7 affiliations
  1. 1Department of Radiopharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  2. 2Health Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran
  3. 3Department of Community and Family Medicine, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
  4. 4Research Center for Nuclear Medicine, Shariati Hospital, North Kargar Ave. 1411713135, Tehran, Iran
  5. 5School of Pharmacy, International Campus, Tehran University of Medical Sciences, Tehran, Iran
  6. 6Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  7. 7Department of Immunology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Abstract

More than 240 million people worldwide are chronically infected with hepatitis B. Although current antiviral therapies effectively inhibit viral replication, they rarely result in a functional cure. The development of hepatitis B surface antigen (HBsAg)-based nanovaccines has emerged as a potential therapeutic strategy. The aim of this systematic review was to investigate a variety of formulations based on this system and determine their therapeutic efficacy in increasing antibody production, reducing HBsAg and hepatitis B virus DNA levels, stimulating T-cell responses, and reducing hepatitis B nuclear antigen (HBcAg)-positive hepatocytes. Studies published from 2015 to 2025 were included if they assessed the therapeutic benefits of HBsAg-based nanovaccines in animal models of chronic hepatitis B (CHB) or in human patients. A search of the PubMed/Medline, Scopus, and Web of Science databases yielded 361 papers, of which eight, including seven preclinical trials and one clinical trial, satisfied the inclusion criteria. Both HBsAg-containing protein-based and mRNA-based nanovaccines demonstrated a significant ability to increase antibody production, reduce viral markers (HBsAg, HBV DNA, HBcAg, and cccDNA), and induce robust T-cell activation, while maintaining liver enzyme levels (ALT and AST) within the normal range. PreS1-targeting platforms (such as Ferritin NP-preS1) and mRNA-based lipid nanoparticles encoding HBsAg demonstrated enhanced therapeutic efficacy. The well-tolerated εPA-44 liposome vaccines, which were in phase II trials, demonstrated favorable clearance of HBV DNA. In conclusion, HBsAg-based nanovaccines show promising therapeutic potential for CHB by restoring antiviral immunity and reducing viral persistence. Large-scale clinical trials are necessary to confirm their efficacy and long-term safety.

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Cite

BibTeXRIS
BibTeX
@article{marnani2026chemical,
  title = {{Chemical Design and Therapeutic Efficacy of HBsAg-Based Nanovaccines for Hepatitis B Virus Clearance: A Preclinical and Clinical Systematic Review}},
  author = {Hasti Nequi Marnani and Tahereh Zadeh Mehrizi and Babak Eshrati and Mehdi Shafiee Ardestani and Nazanin Ajdary and Mohammad Vodjgani and Nariman Mosaffa},
  journal = {Advanced Pharmaceutical Bulletin},
  year = {2026},
  month = may,
  doi = {10.34172/apb.45985},
  url = {https://doi.org/10.34172/apb.45985},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Chemical Design and Therapeutic Efficacy of HBsAg-Based Nanovaccines for Hepatitis B Virus Clearance: A Preclinical and Clinical Systematic Review
AU  - Hasti Nequi Marnani
AU  - Tahereh Zadeh Mehrizi
AU  - Babak Eshrati
AU  - Mehdi Shafiee Ardestani
AU  - Nazanin Ajdary
AU  - Mohammad Vodjgani
AU  - Nariman Mosaffa
PY  - 2026
DA  - 2026/05/19
JO  - Advanced Pharmaceutical Bulletin
DO  - 10.34172/apb.45985
UR  - https://doi.org/10.34172/apb.45985
AB  - More than 240 million people worldwide are chronically infected with hepatitis B. Although current antiviral therapies effectively inhibit viral replication, they rarely result in a functional cure. The development of hepatitis B surface antigen (HBsAg)-based nanovaccines has emerged as a potential therapeutic strategy. The aim of this systematic review was to investigate a variety of formulations based on this system and determine their therapeutic efficacy in increasing antibody production, reducing HBsAg and hepatitis B virus DNA levels, stimulating T-cell responses, and reducing hepatitis B nuclear antigen (HBcAg)-positive hepatocytes. Studies published from 2015 to 2025 were included if they assessed the therapeutic benefits of HBsAg-based nanovaccines in animal models of chronic hepatitis B (CHB) or in human patients. A search of the PubMed/Medline, Scopus, and Web of Science databases yielded 361 papers, of which eight, including seven preclinical trials and one clinical trial, satisfied the inclusion criteria. Both HBsAg-containing protein-based and mRNA-based nanovaccines demonstrated a significant ability to increase antibody production, reduce viral markers (HBsAg, HBV DNA, HBcAg, and cccDNA), and induce robust T-cell activation, while maintaining liver enzyme levels (ALT and AST) within the normal range. PreS1-targeting platforms (such as Ferritin NP-preS1) and mRNA-based lipid nanoparticles encoding HBsAg demonstrated enhanced therapeutic efficacy. The well-tolerated εPA-44 liposome vaccines, which were in phase II trials, demonstrated favorable clearance of HBV DNA. In conclusion, HBsAg-based nanovaccines show promising therapeutic potential for CHB by restoring antiviral immunity and reducing viral persistence. Large-scale clinical trials are necessary to confirm their efficacy and long-term safety.
SN  - 2228-5881
SN  - 2251-7308
ER  -