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Immunogenicity and safety of a recombinant gE-Fc fusion protein subunit vaccine for herpes zoster in adults ≥50 years of age: a randomised, active-controlled, non-inferiority trial

Author

Listed:
  • Peng-Fei Jin

    (China Pharmaceutical University
    Jiangsu Province Center for Disease Control and Prevention
    Nanjing Medical University)

  • Ya-Ru Quan

    (National Institutes for Food and Drug Control)

  • Shi-Xin Xiu

    (Wuxi Center for Disease Control and Prevention)

  • Xian-Min Jiang

    (Beijing Luzhu Biotechnology Co. Ltd.)

  • Hong-Xing Pan

    (Jiangsu Province Center for Disease Control and Prevention
    Nanjing Medical University)

  • Yuan Shen

    (Wuxi Center for Disease Control and Prevention)

  • Xu-Wen Wang

    (Wuxi Center for Disease Control and Prevention)

  • Jian Kong

    (Beijing Luzhu Biotechnology Co. Ltd.)

  • Wen-Juan Wang

    (Jiangsu Province Center for Disease Control and Prevention)

  • Xiang Cao

    (Southeast University)

  • Kang-Wei Xu

    (National Institutes for Food and Drug Control)

  • Min Yang

    (Wuxi Center for Disease Control and Prevention)

  • Kun Yang

    (Wuxi Center for Disease Control and Prevention)

  • Wen-Yan Wan

    (National Institutes for Food and Drug Control)

  • Kai-Qin Wang

    (National Institutes for Food and Drug Control)

  • Li Chen

    (Southeast University)

  • Ai-Hua Yao

    (Southeast University)

  • Yu-Peng Xue

    (Yunnan University)

  • Na Wan

    (Yunnan University)

  • Ming Xu

    (Jiangsu Province Center for Disease Control and Prevention)

  • Shi-Yao Tao

    (Southeast University)

  • Ling Peng

    (Beijing Luzhu Biotechnology Co. Ltd.)

  • Fang-Rong Yan

    (China Pharmaceutical University)

  • Chang-Gui Li

    (National Institutes for Food and Drug Control)

  • Jing-Xin Li

    (China Pharmaceutical University
    Jiangsu Province Center for Disease Control and Prevention
    Nanjing Medical University
    Southeast University)

Abstract

The licensed adjuvanted recombinant glycoprotein E (gE) subunit vaccine (HZ/su) is highly effective against herpes zoster (HZ). This randomised, active-controlled, non-inferiority trial (ChiCTR2300079076) compared the immunogenicity and safety of a novel gE-Fc fusion protein vaccine candidate (LZ901) with HZ/su in 300 healthy adults aged ≥50 years without prior HZ vaccination in Wuxi, China. Participants received either two doses of LZ901 (30-day interval; n = 151) or HZ/su (60-day interval; n = 149). The primary outcomes was the proportion of participants with simultaneous positive responses to two or more cytokines (IFN-γ, IL-2, TNF-α, or CD40L) 30 days after the second dose (referred to as gE-specific CD42+/CD82+ T-cell responses). LZ901 demonstrated non-inferiority to HZ/su (margin > −10%) for both CD4+ and CD8+ T-cell responses. Significantly higher response rates were observed with LZ901 for CD42 + T-cell responses (83.0% [117/141] vs 58.1% [79/136]; p

Suggested Citation

  • Peng-Fei Jin & Ya-Ru Quan & Shi-Xin Xiu & Xian-Min Jiang & Hong-Xing Pan & Yuan Shen & Xu-Wen Wang & Jian Kong & Wen-Juan Wang & Xiang Cao & Kang-Wei Xu & Min Yang & Kun Yang & Wen-Yan Wan & Kai-Qin W, 2025. "Immunogenicity and safety of a recombinant gE-Fc fusion protein subunit vaccine for herpes zoster in adults ≥50 years of age: a randomised, active-controlled, non-inferiority trial," Nature Communications, Nature, vol. 16(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-62800-z
    DOI: 10.1038/s41467-025-62800-z
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