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核酸疫苗研发态势与发展建议

李爱花,杨雪梅,孙轶楠,苑亚坤,杨俊涛

《中国工程科学》 2021年第23卷第4期页码 153-161 doi: 10.15302/J-SSCAE-2021.04.018

摘要：

应对新型冠状病毒肺炎（COVID-19）疫情防控的迫切需求，核酸疫苗以其快速高效的优点得到了疫苗研发领域的高度重视，特别是信使核糖核酸（mRNA）疫苗的研发进程显著加快，首次获批上市并在人体中使用。本文从核酸疫苗及相关技术概念、研发轨迹与发展趋势等方面总结梳理核酸疫苗的研发态势，辨识核酸疫苗特征，分析 COVID-19 疫情对 mRNA疫苗研究的促进作用，梳理核酸疫苗拓展应用的主要领域，针对可能存在的技术性研究建议，从改良目的基因表达、完善递送系统、提高免疫应答、增强 mRNA 稳定性及易存性等方面着手，着力开展核酸疫苗的关键技术开发；严格监管核酸疫苗的安全性和有效性；引导利益相关方对具有安全性风险、可能对肿瘤与传染病防控带来颠覆性影响的mRNA 疫苗技术开展改进研究，注重技术研发的前瞻布局并促进应用转化。

关键词：核酸疫苗脱氧核糖核酸（DNA）疫苗核糖核酸（RNA）疫苗信使核糖核酸（mRNA）疫苗新型冠状病毒肺炎肿瘤

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信息科学应引领未来的生物医学研究 Perspective

Kenta Nakai

《工程（英文）》 2019年第5卷第6期页码 1155-1158 doi: 10.1016/j.eng.2019.07.023

摘要：

笔者从长期回顾的角度阐述了对人工智能（AI）/数据科学与生物医学之间关系的看法。随着新技术的不断出现，现代生物医学的发展持续加速。由于所有生命系统基本上都受其自身DNA中信息的支配，因此信息科学对生物医学的研究具有特别重要的意义。与物理学不同，在生物学中没有发现（或很少有）主导定律。因此，在生物学中，“数据到知识”方法很重要。人工智能在历史上一直应用于生物医学，最近的新闻表明，基于人工智能的方法在国际蛋白质结构预测竞争中获得了最佳性能，这可能被视为该领域的另一个里程碑。类似的方法可能有助于解决基因组序列解释中的问题，如确定患者基因组中的癌症驱动突变。最近，新一代测序（NGS）的爆炸性发展已产生大量数据，并且这种趋势将加速。NGS不仅用于“读取”DNA序列，而且还用于在单细胞水平上获得各种类型的信息。这些数据可以视为气候模拟中的网格数据点。数据科学和人工智能对于这些数据的综合解释/模拟都将变得至关重要，并将在未来的精密医学中起主导作用。

关键词：数据科学人工智能下一代测序脱氧核糖核酸癌症基因组单细胞转录组学

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新冠病毒变异株——新型mRNA疫苗能否经受挑战？

Jennifer Welsh

《工程（英文）》 2021年第7卷第6期页码 712-714 doi: 10.1016/j.eng.2021.04.005

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Using mRNA to investigate the effect of low-pressure ultraviolet disinfection on the viability of

Chao Yang, Wenjun Sun, Xiuwei Ao

《环境科学与工程前沿（英文）》 2019年第13卷第2期 doi: 10.1007/s11783-019-1111-x

摘要：

UV can induce damages on mRNA consistently among different genes.

SOS response was more active after UV treatment.

Programmed cell death was not found to be more active after UV treatment.

关键词： UV disinfection Viability mRNA SOS response Programmed cell death

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疫苗获取难题促使发展中国家研发本土疫苗

Chris Palmer

《工程（英文）》 2022年第15卷第8期页码 3-5 doi: 10.1016/j.eng.2022.06.001

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Novel mutation c.1210-3C>G in with a poly-T tract of 5T affects mRNA splicing in a Chinese patient

《医学前沿（英文）》 2022年第16卷第1期页码 150-155 doi: 10.1007/s11684-021-0846-5

摘要： Cystic fibrosis (CF) is a rare autosomal recessive disease with only one pathogenic gene cystic fibrosis transmembrane conductance regulator (CFTR). To identify the potential pathogenic mutations in a Chinese patient with CF, we conducted Sanger sequencing on the genomic DNA of the patient and his parents and detected all 27 coding exons of CFTR and their flanking intronic regions. The patient is a compound heterozygote of c.2909G>A, p.Gly970Asp in exon 18 and c.1210-3C>G in cis with a poly-T of 5T (T5) sequence, 3 bp upstream in intron 9. The splicing effect of c.1210-3C>G was verified via minigene assay in vitro, indicating that wild-type plasmid containing c.1210-3C together with T7 sequence produced a normal transcript and partial exon 10-skipping-transcript, whereas mutant plasmid containing c.1210-3G in cis with T5 sequence caused almost all mRNA to skip exon 10. Overall, c.1210-3C>G, the newly identified pathogenic mutation in our patient, in combination with T5 sequence in cis, affects the CFTR gene splicing and produces nearly no normal transcript in vitro. Moreover, this patient carries a p.Gly970Asp mutation, thus confirming the high-frequency of this mutation in Chinese patients with CF.

关键词： cystic fibrosis CFTR splicing mutation minigene

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药品监管科学推动中国新冠病毒疫苗研发概述 Review

黄志明, 付志浩, 王军志

《工程（英文）》 2022年第10卷第3期页码 127-132 doi: 10.1016/j.eng.2022.01.001

摘要：在甲型H1N1流感、严重急性呼吸综合征（SARS）和中东呼吸综合征（MERS）等传染病大流行期间，监管科学研究有力支持了抗病毒药物和疫苗的研发。特别在新型冠状病毒（简称新冠病毒）肺炎（COVID-19）疫情大流行期间，药品监管科学支持下的疫苗研发在疫情防控中发挥了重要作用。本文总结了中国疫苗产业、新冠病毒疫苗研发以及疫苗监管科学发展的总体概况。此外，本文重点从国家规划、法律法规、技术指南、质量控制和疫苗上市后监管等方面，回顾和分析了监管科学研究为推动中国新冠病毒疫苗研发所发挥的重要作用。本文为当前大流行阶段以及后疫情时代的疫苗研发策略制定提供参考，并为将来如何更好地应对新发和再发传染病提供借鉴和指导。

关键词：监管科学新冠病毒疫苗疫苗产业

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Tim-3 mRNA expression in peripheral blood lymphocytes from asthmatic patients

Xiaoxia LU, Weikun HU, Shengdao XIONG, Guopeng XU, Fen LAN

《医学前沿（英文）》 2009年第3卷第2期页码 187-190 doi: 10.1007/s11684-009-0033-6

摘要： The study aimed to detect the expression of the Th1-specific cell surface protein T cell Ig and mucin domain-containing molecule-3 (Tim-3) mRNA in peripheral blood lymphocytes isolated from asthmatic patients and to examine the correlation among Tim-3 mRNA, interleukin-4 (IL-4), interferon-γ (IFN-γ) level, and FEV1/FVC (force expiratory volume in one second/forced vital capacity) to explore the role of Tim-3 in the development and progression of asthmatic inflammation. Tim-3 mRNA expression was detected by reverse transcription polymerase chain reaction (RT-PCR). The IL-4 and IFN-γ levels were determined by using enzyme-linked immunosorbent assay (ELISA). The correlation among Tim-3 mRNA, IL-4, IFN-γ level, and pulmonary ventilatory capacity was analyzed. The expression of Tim-3 mRNA in patients with acute asthma exacerbation was 0.39±0.06, significantly higher than that in patients at the remission stage and controls (0.18±0.05 and 0.07±0.03, <0.05). The level of IL-4 in patients with acute asthma exacerbation was 68.42±10.54, significantly higher than that in the patients at the remission stage and controls (41.83±9.37 and 32.75±8.16, <0.05). The level of IL-4 in patients in remission was significantly higher than that in controls ( <0.05). The level of IFN-γ in patients with acute asthma exacerbation was 65.74±7.85, significantly lower than that in patients in remission and the control group (120.84±11.62 and 139.65±13.47, <0.05). The level of IFN-γ in patients in asthma remission was significantly lower than that in controls ( <0.05). Tim-3 mRNA expression was positively correlated with the level of IL-4 ( =0.68, <0.05) and negatively with the level of IFN-γ and pulmonary ventilatory capacity ( =-0.85, =-0.76, both <0.01). The increased expression of Tim-3 mRNA in peripheral blood lymphocytes might be involved in the development and progression of asthmatic inflammation.

关键词： asthma airway inflammation peripheral blood lymphocyte Tim-3

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Effects of hypoxia on mRNA expression of housekeeping genes in rat brain tissue and primary cultured

YANG Yingzhong, MA Lan, GE Rili, FAN Wenhong, ZHU Lingling, ZHAO Tong, WU Yan, FAN Ming

《医学前沿（英文）》 2008年第2卷第3期页码 239-243 doi: 10.1007/s11684-008-0045-7

摘要： Internal standards are critical for quantitative RNA analyses. Housekeeping genes are often used as internal standards with the assumption that their expression levels remain relatively constant in different experimental conditions. In this study, four commonly used housekeeping genes, Glyceraldehyde-3-phosphate dehydrogenase (GAPDH), ?-actin, 28S rRNA and 18S rRNA were selected to test whether this assumption is tenable under hypoxic conditions. We tested the RNA expression level of these four genes in different hypoxic conditions. Rats subjected to acute hypoxia for 2 hours were used for tissue detection. Primary cultured neural stem cells from E13 fetal rats were treated with 3% O or 10% O for 24 hours for experiments. In both experiments, expression levels of 28S rRNA and 18S rRNA were constant, independent of hypoxia types. However, expression levels of GAPDH and ?-actin were all changed in all kinds of hypoxic conditions. In particular, the mRNA expression level of GAPDH was increased by 43.4% under 3% O hypoxic conditions. These results suggest that 18S rRNA and 28S rRNA are reliable internal controls for comparative analyses of transcription under hypoxia. GAPDH appears particularly unfavorable for this purpose in hypoxic conditions.

关键词： Glyceraldehyde-3-phosphate dehydrogenase comparative constant unfavorable independent

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新冠病毒肺炎疫苗分配 ——模拟可替代策略的健康结局和公正性影响 Article

Maddalena Ferranna, Daniel Cadarette, David E. Bloom

《工程（英文）》 2021年第7卷第7期页码 924-935 doi: 10.1016/j.eng.2021.03.014

摘要：

鉴于缺乏安全有效的新冠病毒肺炎（COVID-19）疫苗，一个主要的政策问题是如何在不同的社会人口学特征群体中分配疫苗。本文评估了迄今为止提出的COVID-19疫苗优先策略，重点关注其既定目标；所选分配方案对于大流行病进程和负担的影响机制；以及制定优先策略时出现的流行病学、经济、后勤和政治等主要问题。我们证明了优先考虑重点岗位人群是减少病例数量和降低死亡损失生命年的可行策略，而在大多数情况下，通过优先考虑老年人来实现死亡人数的最大减少，即使疫苗能有效阻止病毒传播。这一特性的不确定性和疫苗针剂支付的潜在延迟加强了优先考虑老年人的呼吁。此外，我们还调查了支持分配策略的公平动机的强度，该策略将绝对优先考虑给予重点岗位人群能降低感染致死风险的疫苗。

关键词：疫苗分配 COVID-19 公正性 SEIR模型

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重组治疗性乙型肝炎疫苗（YIC）的实验研究

闻玉梅,何丽芳,瞿涤,马张妹,姚忻

《中国工程科学》 1999年第1卷第1期页码 38-42

摘要：

研制了抗原-抗体复合物型乙肝治疗性疫苗。用小鼠实验证明这一治疗性疫苗的作用机理为：通过复合物中抗体Fc段与抗原呈递细胞表面的Fc受体结合，促进了细胞摄取抗原。复合物还可诱生更强的细胞免疫，表现为经特异的抗原刺激后，γ-干扰素的mRNA量增多。还发现复合物可在对HBsAg低应答鼠系中（B 10.S）诱生与正常应答鼠相当的抗体效价。在HBsAg阳性转基因鼠中，复合物可使部分鼠的HBsAg转为阴性，并可产生抗-HBs，反映这一疫苗具有疗效。为制备人用乙肝治疗性疫苗建立了用重组酵母菌表达的HBsAg与人高效价抗乙肝免疫球蛋白组建治疗性疫苗的工艺，以及产品标化及效力的参比实验技术。

关键词：乙型肝炎治疗性疫苗抗原抗体复合物免疫应答

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疫苗：我国海水鱼类养殖业向工业化转型的重要支撑

马悦,张元兴,雷霁霖

《中国工程科学》 2014年第16卷第9期页码 4-9

摘要：

国际上水产养殖发达国家和地区的成功产业实践证实，接种疫苗在规模化、集约化的海水鱼类工业化进程中扮演着重要角色。疫苗的广泛应用为大幅度减少抗生素等化学药物的使用起到显著效应，为海水养殖业的健康和可持续发展发挥着关键性的产业支撑作用。随着国家鲆鲽类产业技术体系为代表的海水鱼类疫苗的研究和商业化开发所取得的不断突破，我国海水鱼类养殖业的病害防治策略正在朝着以疫苗接种为核心的产业方向快速迈进。

关键词：海水鱼类养殖国内外现状工业化转型病害防治疫苗发展趋势

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Changes in lncRNAs and related genes in β-thalassemia minor and β-thalassemia major

null

《医学前沿（英文）》 2017年第11卷第1期页码 74-86 doi: 10.1007/s11684-017-0503-1

摘要：

β-thalassemia is caused by β-globin gene mutations. However, heterogeneous phenotypes were found in individuals with same genotype, and still undescribed mechanism underlies such variation. We collected blood samples from 30 β-thalassemia major, 30 β-thalassemia minor patients, and 30 matched normal controls. Human lncRNA Array v2.0 (8 × 60 K, Arraystar) was used to detect changes in long non-coding RNAs (lncRNAs) and mRNAs in three samples each from β-thalassemia major, β-thalassemia minor, and control groups. Compared with normal controls, 1424 and 2045 lncRNAs were up- and downregulated, respectively, in β-thalassemia major patients, whereas 623 and 349 lncRNAs were up- and downregulated, respectively, in β-thalassemia minor patients. Compared with β-thalassemia minor group, 1367 and 2356 lncRNAs were up- and downregulated, respectively, in β-thalassemia major group. We selected five lncRNAs that displayed altered expressions (DQ583499, X-inactive specific transcript (Xist), lincRNA-TPM1, MRFS16P, and lincRNA-RUNX2-2) and confirmed their expression levels in all samples using real-time polymerase chain reaction. Based on coding-non-coding gene co-expression network and gene ontology biological process analyses, several signaling pathways were associated with three common organ systems exhibiting β-thalassemia phenotypes: hematologic, skeletal, and hepatic systems. This study implicates that abnormal expression levels of lncRNAs and mRNA in β-thalassemia cases may be correlated with its various clinical phenotypes.

关键词： β-thalassemia long non-coding RNA mRNA phenotypic heterogeneity pathway

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新冠病毒肺炎疫苗研制面临的挑战

陈薇, 朱凤才

《工程（英文）》 2020年第6卷第10期页码 1067-1069 doi: 10.1016/j.eng.2020.08.012

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Expression pattern and regulation of head-to-head genes

Xinxing CUI,Chunhong YANG,Li KANG,Guiyu ZHU,Qingqing WEI,Yunliang JIANG

《农业科学与工程前沿（英文）》 2014年第1卷第2期页码 130-136 doi: 10.15302/J-FASE-2014013

摘要： Vacuolar protein sorting 36 (VPS36), a protein primarily known for its role in the Endosomal Sorting Complex Required for Transport pathway, has recently been shown to be linked to chicken reproduction. Previous research showed that is significantly downregulated in sexually mature chicken ovaries compared to immature ones. In this study, using real-time quantitative RT-PCR, we investigated the expression pattern of and its head-to-head gene mRNA in chicken follicles. Small white follicles were found to have significantly higher expression of and mRNA than any other sized follicles ( <0.05). The expression of and mRNA were detected in both granulosa and theca layers of pre-ovulatory follicles, the expression of in theca layers was slightly higher than in granulosa cells. Treatment of small yellow follicles with follicle-stimulating hormone and estradiol resulted in a marked decrease of both and mRNA ( <0.05); however, progesterone, transforming growth factor-β 1 and luteinizing hormone induced no significant changes in and mRNA expression in these follicles. These results indicate that the head-to-head genes of and exhibit similar expression in chicken follicles and are involved in chicken follicle development.

关键词： chicken Vps36 Ckap2 mRNA follicle