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基于大肠杆菌表达的重组九价人乳头瘤病毒(HPV 6/11/16/18/31/33/45/52/58型)疫苗免疫原性和安全性的Ⅱ期临床试验 被引量:2
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作者 胡月梅 毕兆峰 +24 位作者 郑亚 张黎 郑凤珠 储凯 李亚飞 陈祺 全佳丽 胡潇文 黄兴成 朱孔鑫 王江雅慧 姜汉民 臧霞 刘东林 杨昌林 潘红星 张秋芬 苏迎盈 黄守杰 孙光 黄维金 黄悦 吴婷 张军 夏宁邵 《Science Bulletin》 SCIE EI CAS CSCD 2023年第20期2448-2455,M0006,共9页
人乳头瘤病毒(HPV)16/18型双价疫苗(大肠埃希菌)已上市并通过世界卫生组织预认证.本研究通过一项随机双盲Ⅱ期临床试验评估其第二代HPV6/11/16/18/31/33/45/52/58型九价疫苗在18~45岁健康女性中的免疫原性和安全性.来自江苏省东台市的62... 人乳头瘤病毒(HPV)16/18型双价疫苗(大肠埃希菌)已上市并通过世界卫生组织预认证.本研究通过一项随机双盲Ⅱ期临床试验评估其第二代HPV6/11/16/18/31/33/45/52/58型九价疫苗在18~45岁健康女性中的免疫原性和安全性.来自江苏省东台市的627名女性志愿者1:1随机分配至九价疫苗组(313人)或对照组(314人),并按照0、1、6月接种程序分别接种三剂1.0 mL(270μg)九价疫苗或空白佐剂,主要终点为第7月时血清抗体阳转率和抗体水平.结果显示,几乎所有疫苗组符合方案人群在第7月时出现针对9种HPV型别的血清中和抗体阳转,仅2人未发生HPV11型阳转,1人未发生HPV52型阳转.九价疫苗组和对照组的总体不良事件发生率分别为80.8%和72.9%,绝大多数不良事件症状轻微并很快恢复,未发生疫苗相关严重不良事件.该研究证明候选九价疫苗具有良好的安全性和免疫原性,支持在更大人群中进一步进行效力研究. 展开更多
关键词 Ⅱ期临床试验 免疫原性 人乳头瘤病毒 江苏省东台市 双价疫苗 大肠杆菌表达 随机分配 大肠埃希菌
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Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs.3 doses in young women 被引量:20
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作者 yue-mei hu Meng Guo +20 位作者 Chang-Gui Li Kai Chu Wen-Gang He Jing Zhang Jian-Xiang Gu Juan Li hui Zhao Xiang-Hong Wu Bi-Zhen Lin Zhi-Jie Lin Xing-Mei Yao Ya-Fei Li Fei-Xue Wei Yue huang Ying-Ying Su Feng-Cai Zhu Shou-Jie huang hui-Rong Pan Ting Wu Jun Zhang Ning-Shao Xia 《Science China(Life Sciences)》 SCIE CAS CSCD 2020年第4期582-591,共10页
A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women.A randomized,immunogenicity noninferiority study of this candidate vaccine was conducted in December ... A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women.A randomized,immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China.Girls aged 9–14 years were randomized to receive 2 doses at months 0 and 6(n=301)or 3 doses at months 0,1 and 6(n=304).Girls aged 15–17 years(n=149)and women aged 18–26 years(n=225)received 3 doses.The objectives included noninferiority analysis of the IgG geometric mean concentration(GMC)ratio(95%CI,lower bound>0.5)to HPV-16 and HPV-18 at month 7 in girls compared with women.In the per-protocol set,the GMC ratio of IgG was noninferior for girls aged 9–17 years receiving 3 doses compared with women(1.76(95%CI,1.56,1.99)for HPV-16 and 1.93(95%CI,1.69,2.21)for HPV-18)and noninferior for girls aged 9–14 years receiving 2 doses compared with women(1.45(95%CI,1.25,1.62)for HPV-16 and 1.17(95%CI,1.02,1.33)for HPV-18).Noninferiority was also demonstrated for neutralizing antibodies.The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women. 展开更多
关键词 immunobridging NONINFERIORITY human PAPILLOMAVIRUS vaccine ESCHERICHIA COLI GIRLS
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TGF-β1-regulated miR-3691-3p targets E2F3 and PRDM1 to inhibit prostate cancer progression 被引量:3
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作者 yue-mei hu Xiao-Li Lou +9 位作者 Bao-Zhu Liu Li Sun Shan Wan Lei Wu Xin Zhao Qing Zhou Mao-Min Sun Kun Tao Yong-Sheng Zhang Shou-Li Wang 《Asian Journal of Andrology》 SCIE CAS CSCD 2021年第2期188-196,共9页
Transforming growth factor-β1(TGF-β1)acts as a tumor promoter in advanced prostate cancer(PCa).We speculated that microRNAs(miRNAs)that are inhibited by TGF-β1 might exert anti-tumor effects.To assess this,we ident... Transforming growth factor-β1(TGF-β1)acts as a tumor promoter in advanced prostate cancer(PCa).We speculated that microRNAs(miRNAs)that are inhibited by TGF-β1 might exert anti-tumor effects.To assess this,we identified several miRNAs downregulated by TGF-β1 in PCa cell lines and selected miR-3691-3p for detailed analysis as a candidate anti-oncogene miRNA.miR-3691-3p was expressed at significantly lower levels in human PCa tissue compared with paired benign prostatic hyperplasia tissue,and its expression level correlated inversely with aggressive clinical pathological features.Overexpression of miR-3691-3p in PCa cell lines inhibited proliferation,migration,and invasion,and promoted apoptosis.The miR-3691-3p target genes E2F transcription factor 3(E2F3)and PR domain containing 1,with ZNF domain(PRDM1)were upregulated in miR-3691-3p-overexpressing PCa cells,and silencing of E2F3 or PRDM1 suppressed PCa cell proliferation,migration,and invasion.Treatment of mice bearing PCa xenografts with a miR-3691-3p agomir inhibited tumor growth and promoted tumor cell apoptosis.Consistent with the negative regulation of E2F3 and PRDM1 by miR-3691-3p,both proteins were overexpressed in clinical PCa specimens compared with noncancerous prostate tissue.Our results indicate that TGF-β1-regulated miR-3691-3p acts as an anti-oncogene in PCa by downregulating E2F3 and PRDM1.These results provide novel insights into the mechanisms by which TGF-β1 contributes to the progression of PCa. 展开更多
关键词 E2F transcription factor 3 miR-3691-3p PR domain containing 1 with ZNF domain prostate cancer transforming growth factor-β1
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Retraction note:TGF-β1-regulated miR-3691-3p targets E2F3 and PRDM1 to inhibit prostate cancer progression
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作者 yue-mei hu Xiao-Li Lou +9 位作者 Bao-Zhu Liu Li Sun Shan Wan Lei Wu Xin Zhao Qing Zhou Mao-Min Sun Kun Tao Yong-Sheng Zhang Shou-Li Wang 《Asian Journal of Andrology》 SCIE CAS CSCD 2022年第6期684-684,共1页
We are retracting this article due to certain errors in two figures in the article"TGF-β1-regulated miR-3691-3p targets E2F3 and PRDM1 to inhibit prostate cancer progression"which has been published.An imag... We are retracting this article due to certain errors in two figures in the article"TGF-β1-regulated miR-3691-3p targets E2F3 and PRDM1 to inhibit prostate cancer progression"which has been published.An image layout error occurred while processing Figure 3e,and some of the images in Figure 3f,4d,and 4e have errors due to incorrect image grouping.We carried out a detailed investigation and rechecked the original data of these figures.Unfortunately,the original pathological data have not been properly archived;thus,we are unable to investigate this issue. 展开更多
关键词 E2F3 PRDM1 cancer
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