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

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 Wang, Li Chen, Ai-Hua Yao, Yu-Peng Xue, Na Wan, Ming Xu, Shi-Yao Tao, Ling Peng (), Fang-Rong Yan (), Chang-Gui Li () and Jing-Xin Li ()
Additional contact information
Peng-Fei Jin: China Pharmaceutical 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
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

Nature Communications, 2025, vol. 16, issue 1, 1-11

Abstract: 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

Date: 2025
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DOI: 10.1038/s41467-025-62800-z

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