≥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

IF 15.7 1区 综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES
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
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引用次数: 0

摘要

经批准的佐剂重组糖蛋白E (gE)亚单位疫苗(HZ/su)对带状疱疹(HZ)非常有效。这项随机、主动对照、非效性试验(ChiCTR2300079076)比较了一种新型gE-Fc融合蛋白候选疫苗(LZ901)在中国无锡300名年龄≥50岁、未接种过HZ疫苗的健康成人中与HZ/su的免疫原性和安全性。参与者接受两剂LZ901(间隔30天;n = 151)或HZ/su(60天间隔;n = 149)。主要结果是在第二次剂量后30天同时对两种或多种细胞因子(IFN-γ, IL-2, TNF-α或CD40L)产生阳性反应的参与者比例(称为ge特异性CD42+/CD82+ t细胞反应)。LZ901对CD4+和CD8+ t细胞反应均表现出HZ/su的非劣效性(边际>;−10%)。LZ901治疗CD42 + t细胞应答的有效率显著高于前者(83.0% [117/141]vs . 58.1% [79/136];p < 0.0001)和CD82 + t细胞应答(46.8% [66/141]vs 8.8% [12/136];p < 0.0001)。LZ901组不良反应明显低于前者(41.1% [62/151]vs . 87.9% [131/149]);P < 0.0001),包括3级事件(0.7% [1/151]vs 6.0%[9/149])。LZ901诱导了卓越的细胞免疫原性,并且在≥50岁的成人中表现出比HZ/su更好的安全性,支持其作为有希望的HZ预防候选疫苗的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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.

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来源期刊
Nature Communications
Nature Communications Biological Science Disciplines-
CiteScore
24.90
自引率
2.40%
发文量
6928
审稿时长
3.7 months
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.
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