A Single-center, Randomized, Blinded, and Positive Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above

This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization.

开始日期2024-10-13

申办/合作机构

中国医学科学院医学生物学研究所

[+1]

NCT06460545 / Not yet recruiting临床4期IIT

Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Freeze-dried Live-attenuated Hepatitis A Vaccine or Inactivated Hepatitis A Vaccine

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.

开始日期2024-06-15

申办/合作机构

中国医学科学院医学生物学研究所

NCT06184542 / Recruiting临床1期IIT

To Evaluate Safety and Preliminary Immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children Aged 2 Months to 6 Years: A Randomized, Blinded, Active-controlled Phase I Clinical Trial

This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.

开始日期2023-12-23

申办/合作机构

中国医学科学院医学生物学研究所

[+1]

100 项与中国医学科学院医学生物学研究所相关的临床结果

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项与中国医学科学院医学生物学研究所相关的文献（医药）

2024-08-01·International journal of mental health and addiction

Trends of the Global Burden of Disease Attributable to Cannabis Use Disorder in 204 Countries and Territories, 1990–2019: Results from the Disease Burden Study 2019

Article

作者: Gu, Yingqi ; Lu, Junyan ; Du, Heyue ; Duan, Jing ; Zhu, Yanqing ; Qu, Lang ; Chen, Meiling ; Chen, Zhuangfei ; Ye, Dequan ; Li, Yutong ; Shao, Heng ; Zhu, Shasha ; Gan, Quan

Abstract:

Cannabis is the fourth psychoactive substance to be legalized which are of far-reaching significance to the world. We analyzed data from the 2019 Global Burden of Disease Study (GBD) to estimate the incidence and prevalence of cannabis use disorder (CUD) and calculated the disease burden of CUD in 204 countries and territories and 21 regions over the past three decades. We reported disease burden due to CUD in terms of disability-adjusted life years (DALYs), age-standardized rate (ASR), estimated annual percentage change (EAPC), and analyzed associations between the burden of CUD and sociodemographic index (SDI) quintiles. Globally, the number of incidence cases of CUD was estimated to be increasing by 32.3% from 1990 to 2019 and males are nearly double higher than that of female. DALYs increase 38.6% from 1990. Young people aged 20–24 years old with cannabis use disorder have the highest DALYs in 2019, followed by those younger than 20 years old. India, Canada, USA, Qatar, Kenya, and high SDI quintile areas showed a high burden of disease. Nearly 200 million individuals are cannabis users worldwide, and CUD is a notable condition of GBD. The global cultivation of cannabis, rooted in different cultures, diversified access to cannabis, legalization in controversy, the promotion of medical cannabis, and many other factors promote the global cannabis industry is constantly updated and upgraded. It deserves more discussion in the future in terms of pathophysiological mechanisms, socioeconomics, law, and policy improvement.

2022-06-06·World journal of clinical cases

Diagnostic value of bone marrow cell morphology in visceral leishmaniasis-associated hemophagocytic syndrome: Two case reports

作者: Jiang, Hong-Chao ; Xu, Ji ; Shi, Shu-Lan ; Zhou, Beng-Jiang ; Zhao, Heng ; Li, Xiao-Juan ; Ma, Ming-Biao

BACKGROUND:

Visceral leishmaniasis related-hemophagocytic lymphohistiocytosis (VL-HLH) is a hemophagocytic syndrome caused by Leishmania infection. VL-HLH is rare, especially in nonendemic areas where the disease is severe, and mortality rates are high. The key to diagnosing VL-HLH is to find the pathogen; therefore, the Leishmania must be accurately identified for timely clinical treatment.

CASE SUMMARY:

We retrospectively analyzed the clinical data, laboratory examination results, and bone marrow cell morphology of two children with VL-HLH diagnosed via bone marrow cell morphology at Kunming Children's Hospital of Yunnan, China. Both cases suspected of having malignant tumors at other hospitals and who were unresponsive to treatment were transferred to Kunming Children's Hospital. They are Han Chinese girls, one was 2 years old and the other one is 9 mo old. They had repeated fevers, pancytopenia, hepatosplenomegaly, hypertriglyceridemia, and hypofibrinogenemia over a long period and met the HLH-2004 criteria. Their HLH genetic test results were negative. Both children underwent chemotherapy as per the HLH-2004 chemotherapy regimen, but it was ineffective and accompanied by serious infections. We found Leishmania amastigotes in their bone marrow via morphological examination of their bone marrow cells, which showed hemophagocytic cells; thus, the children were diagnosed with VL-HLH. After being transferred to a specialty hospital for treatment, the condition was well-controlled.

CONCLUSION:

Morphological examination of bone marrow cells plays an important role in diagnosing VL-HLH. When clinically diagnosing secondary HLH, VL-HLH should be considered in addition to common pathogens, especially in patients for whom HLH-2004 chemotherapy regimens are ineffective. For infants and young children, bone marrow cytology examinations should be performed several times and as early as possible to find the pathogens to reduce potential misdiagnoses.

2022-02-01·Acta histochemica

Corrigendum to “Protective action of ultrasound-guided intraparenchymal transplantation of BMSCs in adriamycin nephropathy rats through the RIPK3/MLKL and NLRP3 pathways” [Acta Histochem. 123 (2021) 151773]

作者: Zhang, Ya ; Xia, Chunjuan ; Shi, Cheng ; Li, Hongjun ; Li, Jiaqi ; Shao, Lishi ; Wang, Jiaping ; Zhang, Weihu ; Ma, Yiqun ; Wang, Xinghong

项与中国医学科学院医学生物学研究所相关的新闻（医药）

2024-11-16

·生物谷

Cancer Communications | 中国医学科学院胡云章等团队首次在结直肠癌组织中发现类病毒

类病毒是已知的最小的传染性病原体，最初是在植物中发现的，但迄今还未在动物中发现。中国医学科学院医学生物学研究所胡云章团队、云南省肿瘤医院李文亮团队及中国科学院西双版纳热带植物园刘长宁团队合作，使用了一种无参考的计算机算法[1,2]，在结直肠癌患者肿瘤组织中发现了一个新型类病毒样环状RNA，认为它是一种哺乳动物的类病毒，将其命名为结直肠癌相关类病毒(colorectal cancer-associated viroid，CCAV)。这是首次在人类中鉴定出一种尚未发现的类病毒。相关研究结果于2024年11月10日在线发表在Cancer Communications期刊上，论文标题为“Discovery of a novel viroid-like circular RNA in colorectal cancer”[3]。 CCAV仅有114个核苷酸(nt)，可能是目前发现的最小的类病毒。CCAV的二级结构呈环状，不同于所有已知类病毒的棒状构象（具有广泛的碱基配对特征）。随后的BaseScope原位杂交证实CCAV在结直肠癌肿瘤组织中的存在,并经qPCR在100个结直肠癌病人样本中证实了CCAV。此外，从结直肠癌组织中分离的36株细菌中经qPCR也发现CCAV。用CCAV过表达载体转染SW480细胞后，全转录组深度测序显示，SW480细胞中的差异表达基因主要与病毒感染、免疫紊乱和肿瘤有关。这是我国科学家提供的关于类病毒在结直肠癌组织中存在的第一个证据，这一发现标志着首次确定动物中也存在类病毒。这一研究结果修正了以前关于类病毒只存在于植物中的概念，而这一发现有可能改变当前的病毒学范式，表明类病毒可能存在于更广泛的生命系统中。该发现为研究人类疾病开辟了新的途径，值得进一步探索。中国医学科学院医学生物学研究所胡云章研究员为该论文的通讯作者，中国医学科学院医学生物学研究所乌美妮、云南省肿瘤医院李文亮、中国医学科学院医学生物学研究所胡凝珠及中国科学院西双版纳热带植物园刘长宁为论文共同第一作者，李建芳、李彦涵、孙静、施建东、许宁、李菁亦对该工作做出了重要贡献。该工作得到了国家自然科学基金及中国医学科学院创新工程基金的大力支持。参考资料： [1] Wu Q, Wang Y, Cao M, Pantaleo V, Burgyan J, Li WX, Ding SW. Homology-independent discovery of replicating pathogenic circular RNAs by deep sequencing and a new computational algorithm. Proc Natl Acad Sci U S A. 2012 Mar 6;109(10):3938-43. doi: 10.1073/pnas.1117815109. Epub 2012 Feb 15. PMID: 22345560; PMCID: PMC3309787. [2] Zhang Z, Qi S, Tang N, Zhang X, Chen S, Zhu P, Ma L, Cheng J, Xu Y, Lu M, Wang H, Ding SW, Li S, Wu Q. Discovery of replicating circular RNAs by RNA-seq and computational algorithms. PLoS Pathog. 2014 Dec 11;10(12):e1004553. doi: 10.1371/journal.ppat.1004553. PMID: 25503469; PMCID: PMC4263765. [3] Meini Wu, Wenliang Li, Ningzhu Hu, Changning Liu et al. Discovery of a novel viroid-like circular RNA in colorectal cancer. Cancer Communications, 2024, DOI: 10.1002/cac2.12626. 本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！

2024-08-27

·沃森生物

中国首届疫苗学大会在昆明召开沃森生物分享产学研融合成功经验

中国疫苗学大会 8月24日，以“为民族为人类谋划发展疫苗学”为主题的首届中国疫苗学大会在昆明开幕。大会贯彻落实习近平总书记关于“努力把中国医学科学院建设成为我国医学科技创新体系的核心基地”重要指示精神，聚焦疫苗学科前沿重要进展，围绕国家传染病防控重大需求，从疫苗学科建设、产业创新发展、核心技术突破等多维度对疫苗研产学一体化全链条高质量发展进行深入研讨。大会开幕式本届大会由中国医学科学院主办，中国医学科学院医学生物学研究所、北京协和医学院群医学及公共卫生学院、药物研究所、医药生物技术研究所、药用植物研究所共同承办，中国疫苗行业协会支持，北京协和医学院教育基金会资助，比尔及梅琳达·盖茨基金会公益支持，云南省预防医学会协办。大会为期3天，共吸引数名院士和400余位行业精英参会研讨。云南省副省长刘勇致辞云南省人民政府副省长刘勇，出席开幕式并致辞。刘勇副省长指出，云南省积极响应中央政策，推动疫苗产业发展，已成为全国疫苗产业的重要基地。推动科研成果转化需要体制机制创新，特别是新型科研转化机制的建立。希望未来云南省与中国医学科学院建立更加紧密的合作，围绕成果转化和产业化，加快新型举国体制改革步伐，激发创新创造活力，打造云南疫苗产业成为国家新的疫苗产业高地。林金钟教授做专题报告复旦大学生命科学学院特聘教授、复旦大学mRNA药物研发中心主任、上海张江mRNA国际创新中心主任、蓝鹊生物创始人林金钟在本次大会上发表了题为《中国mRNA技术平台的开发》的专题报告。林金钟教授从mRNA疫苗的工艺技术、技术攻克难题、应用前景等方面介绍了中国mRNA技术的发展，并以新冠mRNA疫苗的开发历程为案例介绍了与沃森生物共建的mRNA技术平台情况。其中林教授谈到，沃森生物利用多年的疫苗研发与产业化经验，为mRNA疫苗的产业化与规模化提供了必要的支持。沃森生物董事长李云春做专题报告云南沃森生物技术股份有限公司董事长李云春在会上发表了题为《产学研融合加快mRNA疫苗在中国的应用》的专题报告。从全球十大疫苗的研发模式中可以得出结论，产学研融合是未来疫苗研发和产业化的必然趋势。沃森生物目前拥有着结构完整的“自主研发+并购整合+产学研结合”研发体系。在研发新冠疫苗的过程中，沃森生物与复旦大学、蓝鹊生物、广州实验室共同构建了创新高效的mRNA疫苗技术平台，建立了稳定、可控的全流程mRNA疫苗商业化规模生产工艺，合作研发的国产mRNA疫苗在去年年底获批国家紧急使用。这一疫苗的成功研发，既标志着沃森生物产学研融合的又一次成功，也标志着国内与国际研发水平的差距越来越小。沃森生物展区作为一家拥有20余年丰富疫苗开发和产业化经验的疫苗企业，未来，沃森生物将继续秉持“让人人生而健康”的主旨，坚持在创新疫苗领域的研发投入，持续推进产学研用深度融合，优化并拓展技术平台，让科学家的技术能够实现更多“技术→样品→产品→商品”的转化，为中国疫苗研发事业赋能，为实现健康中国的目标和促进全球公共卫生事业的发展贡献沃森力量。

疫苗信使RNA

2024-06-20

·PRNewswire

Keymed Biosciences Announces Safety and Efficacy Results of CM313 for Primary Immune Thrombocytopenia Published in NEJM

CHENGDU, China, June 20, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced that Lei Zhang/Renchi Yang's team from the Institute of Hematology, Chinese Academy of Medical Sciences has recently published a research paper entitled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" in the New England Journal of Medicine. This is an investigator-initiated, single-arm, open-label phase I/II study evaluating the safety and preliminary efficacy of CM313 in adult patients with primary ITP. A total of 22 patients were enrolled in the study, with one patient dropping out after the first infusion. The remaining 21 patients completed both the 8-week treatment and 16-week follow-up periods. Results showed that 95.5% of patients (21/22) achieved a platelet count of ≥50 × 109/L during the 8-week treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17 to 24). The median time to first platelet count of ≥50 × 109/L was 1 week (range: 1-3), and the median time to first platelet count of ≥30 × 109/L with a ≥2-fold increase from baseline was 1 week. Additionally, the durable sustained platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6% (14/22). Throughout the entire study, overall response (complete or partial response) was observed in 21 patients, with 20 patients achieving complete response. The proportion of patients with bleeding decreased from 68.2% (15/22) at baseline to 4.8 (1/21) at week 8. Most patients discontinued concomitant medications due to the restoration of platelet counts to normal or safe levels with CM313 treatment. In summary, CM313 demonstrated rapid and sustained efficacy in 95.5% of ITP patients who had previously received multiple therapies. Safety analyses showed that CM313 was well-tolerated. CM313 is a humanized monoclonal antibody targeting CD38 and the first domestically-developed anti-CD38 antibody with IND approval by the NMPA in China. Previous phase I/II studies have demonstrated the favorable safety profile and encouraging efficacy of CM313 in patients with RRMM and primary ITP. In addition, the potential use of CM313 in SLE is currently under clinical development. About Keymed Biosciences Inc. Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies. SOURCE Keymed

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药物(靶点)	适应症	全球最高研发状态

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Ⅰ型+Ⅲ型脊髓灰质炎减毒活疫苗糖丸(人二倍体细胞)(中国医学科学院医学生物学研究所)	脊髓灰质炎更多	批准上市
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