Jin Peng-Fei, Quan Ya-Ru, Xiu Shi-Xin, Jiang Xian-Min, Pan Hong-Xing, Shen Yuan, Wang Xu-Wen, Kong Jian, Wang Wen-Juan, Cao Xiang, Xu Kang-Wei, Yang Min, Yang Kun, Wan Wen-Yan, Wang Kai-Qin, Chen Li, Yao Ai-Hua, Xue Yu-Peng, Wan Na, Xu Ming, Tao Shi-Yao, Peng Ling, Yan Fang-Rong, Li Chang-Gui, Li Jing-Xin
School of Science, Institute of Global Health and Emergency Pharmacy, China Pharmaceutical University, Nanjing, China.
NHC Key Laboratory of Enteric Pathogenic Microbiology, Engineering Research Center of Health Emergency, Jiangsu Province Center for Disease Control and Prevention, Nanjing, China.
Nat Commun. 2025 Aug 15;16(1):7590. doi: 10.1038/s41467-025-62800-z.
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 CD4/CD8 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 CD4 + T-cell responses (83.0% [117/141] vs 58.1% [79/136]; p < 0.0001) and CD8 + T-cell responses (46.8% [66/141] vs 8.8% [12/136]; p < 0.0001). Adverse reactions were markedly lower with LZ901 (41.1% [62/151] vs 87.9% [131/149]; p < 0.0001), including grade 3 events (0.7% [1/151] vs 6.0% [9/149]). LZ901 induced superior cellular immunogenicity and exhibited a better safety profile than HZ/su in adults ≥50 years, supporting its potential as a promising HZ prevention candidate vaccine.
获得许可的佐剂重组糖蛋白E（gE）亚单位疫苗（HZ/su）对带状疱疹（HZ）具有高度有效性。这项随机、活性对照、非劣效性试验（ChiCTR2300079076）在中国无锡对300名年龄≥50岁且未曾接种过HZ疫苗的健康成年人，比较了新型gE-Fc融合蛋白候选疫苗（LZ901）与HZ/su的免疫原性和安全性。参与者分别接受两剂LZ901（间隔30天；n = 151）或HZ/su（间隔60天；n = 149）。主要结局是第二次接种后30天对两种或更多种细胞因子（IFN-γ、IL-2、TNF-α或CD40L）同时产生阳性反应的参与者比例（称为gE特异性CD4/CD8 T细胞反应）。对于CD4和CD8 T细胞反应，LZ901均显示出非劣于HZ/su（界值＞-10%）。观察到LZ901的CD4 + T细胞反应（83.0% [117/141] 对58.1% [79/136]；p＜0.0001）和CD8 + T细胞反应（46.8% [66/141] 对8.8% [12/136]；p＜0.0001）的反应率显著更高。LZ901的不良反应明显更低（41.1% [62/151] 对87.9% [131/149]；p＜0.0001），包括3级事件（0.7% [1/151] 对6.0% [9/149]）。在≥50岁的成年人中，LZ901诱导出更好的细胞免疫原性，且安全性优于HZ/su，支持其作为一种有前景的HZ预防候选疫苗的潜力。
