ORIGINAL RESEARCH article

Front. Immunol.

Sec. Nutritional Immunology

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1641109

This article is part of the Research TopicThe Role of Bioactive Compounds and Nutrients in Intestinal Mucosal Immunity, Liver and Vascular InflammationView all articles

A Novel Adjuvant System BK-02 with CpG2006 and MF59 Enhances the Immunogenicity of a Herpes Zoster Subunit Vaccine

Provisionally accepted
Zihan WangZihan Wang1Yingnan GuoYingnan Guo2Xin TangXin Tang2Ying SunYing Sun2Tingting WuTingting Wu2Hanyu PengHanyu Peng1Cenrong WangCenrong Wang1Weiheng SuWeiheng Su1,3Chunlai JiangChunlai Jiang1,2,3Yang ZangYang Zang2*Yaru QuanYaru Quan4*Kangwei XuKangwei Xu4*Bo SunBo Sun1,3*
  • 1Jilin University National Engineering Laboratory for AIDS Vaccine, Changchun, China
  • 2R&D Center, Changchun BCHT Biotechnology Co., Changchun 130012, China, Changchun, China
  • 3Jilin University Key Laboratory for Molecular Enzymology and Engineering of the Ministry of Education, Changchun, China
  • 4National Institutes for Food and Drug Control, Beijing, China

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Reactivation of the varicella-zoster virus (VZV) results in herpes zoster (HZ), which can lead to complications such as postherpetic neuralgia. The commercially available HZ subunit adjuvanted vaccine, Shingrix®, offers significant protection against HZ in older adults. However, the adjuvant system of this vaccine has limitations that necessitate the development of alternative adjuvant systems. In this study, we established a novel adjuvant system, BK-02, composed of both the Tolllike receptor 9 (TLR9) agonist BK-02C (CpG2006) and a squalene-based oil-in-water emulsion, BK-02M (MF59), using ELISA, ELISpot, and flow cytometry analyses. Our results showed that when combined with glycoprotein E (gE), the active ingredient of a recombinant HZ vaccine, the BK-02 adjuvant system elicited significantly higher gE-specific IFN-γ + T-cell responses (486 SFU/10⁶ cells, 121-fold increase vs gE alone) and IgG antibody titers (Lg titers 5.2 vs 3.4 for gE alone). The optimal dose (5 μg gE + 30 μg BK-02C + 1× BK-02M) for inducing gE protein-specific cellular immunity was determined in mice. This corresponded to a clinical dose of "50 μg gE + 300/500 μg BK-02C + 0.5 mL BK-02M." Additionally, pilot-scale samples of the recombinant HZ vaccine demonstrated enhanced gE-specific CD4 + and CD8 + T-cell immune responses, compared to Shingrix®. Moreover, the gE/BK-02 adjuvant system induced a Th1-regulated mixed immune response, enabling robust cellular and humoral immunity. These findings indicated that the BK-02 adjuvant system is a promising adjuvant candidate for the current HZ subunit vaccines.

Keywords: Herpes Zoster Vaccine, Glycoprotein E, Adjuvant system, CpG ODN, MF59, Cellular immunity

Received: 04 Jun 2025; Accepted: 30 Jun 2025.

Copyright: © 2025 Wang, Guo, Tang, Sun, Wu, Peng, Wang, Su, Jiang, Zang, Quan, Xu and Sun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Yang Zang, R&D Center, Changchun BCHT Biotechnology Co., Changchun 130012, China, Changchun, China
Yaru Quan, National Institutes for Food and Drug Control, Beijing, China
Kangwei Xu, National Institutes for Food and Drug Control, Beijing, China
Bo Sun, Jilin University National Engineering Laboratory for AIDS Vaccine, Changchun, China

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Supplementary Material