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, Jing-Xin Li
{"title":"≥50岁成人带状疱疹重组gE-Fc融合蛋白亚单位疫苗的免疫原性和安全性:一项随机、主动对照、非效性试验","authors":"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, Jing-Xin Li","doi":"10.1038/s41467-025-62800-z","DOIUrl":null,"url":null,"abstract":"<p>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<sup>2+</sup>/CD8<sup>2+</sup> T-cell responses). LZ901 demonstrated non-inferiority to HZ/su (margin > −10%) for both CD4<sup>+</sup> and CD8<sup>+</sup> T-cell responses. Significantly higher response rates were observed with LZ901 for CD4<sup>2</sup> + T-cell responses (83.0% [117/141] vs 58.1% [79/136]; p < 0.0001) and CD8<sup>2</sup> + 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.</p>","PeriodicalId":19066,"journal":{"name":"Nature Communications","volume":"20 1","pages":""},"PeriodicalIF":15.7000,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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, Jing-Xin Li\",\"doi\":\"10.1038/s41467-025-62800-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>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<sup>2+</sup>/CD8<sup>2+</sup> T-cell responses). LZ901 demonstrated non-inferiority to HZ/su (margin > −10%) for both CD4<sup>+</sup> and CD8<sup>+</sup> T-cell responses. Significantly higher response rates were observed with LZ901 for CD4<sup>2</sup> + T-cell responses (83.0% [117/141] vs 58.1% [79/136]; p < 0.0001) and CD8<sup>2</sup> + 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.</p>\",\"PeriodicalId\":19066,\"journal\":{\"name\":\"Nature Communications\",\"volume\":\"20 1\",\"pages\":\"\"},\"PeriodicalIF\":15.7000,\"publicationDate\":\"2025-08-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nature Communications\",\"FirstCategoryId\":\"103\",\"ListUrlMain\":\"https://doi.org/10.1038/s41467-025-62800-z\",\"RegionNum\":1,\"RegionCategory\":\"综合性期刊\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MULTIDISCIPLINARY SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nature Communications","FirstCategoryId":"103","ListUrlMain":"https://doi.org/10.1038/s41467-025-62800-z","RegionNum":1,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MULTIDISCIPLINARY SCIENCES","Score":null,"Total":0}
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
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 < 0.0001) and CD82 + 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.
期刊介绍:
Nature Communications, an open-access journal, publishes high-quality research spanning all areas of the natural sciences. Papers featured in the journal showcase significant advances relevant to specialists in each respective field. With a 2-year impact factor of 16.6 (2022) and a median time of 8 days from submission to the first editorial decision, Nature Communications is committed to rapid dissemination of research findings. As a multidisciplinary journal, it welcomes contributions from biological, health, physical, chemical, Earth, social, mathematical, applied, and engineering sciences, aiming to highlight important breakthroughs within each domain.