A prospective, multicenter, randomized controlled clinical study evaluating the safety and efficacy of cryoablation after transurethral bladder tumor resection (TUR) compared to BCG instillation for high-risk non muscle invasive bladder cancer

开始日期2024-03-20

申办/合作机构-

CTRI/2022/07/044500

/ Not yet recruitingN/AIIT

Adult BCG revaccination induced Antibody and cTfh responses in Latent Tuberculosis individuals with or without diabetes mellitus

开始日期2022-11-01

申办/合作机构

Department of Biotechnology, Government of India

CTRI/2022/04/042311

/ Suspended临床3期IIT

Efficacy of BCG revaccination compared with oral chemoprophylaxis in household contacts aged 6-18 years for prevention of Tuberculosis disease – A phase III open labelled randomised control trial.

开始日期2022-05-24

申办/合作机构-

100 项与 Bacillus Calmette-Guerin(ImmunityBio) 相关的临床结果

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100 项与 Bacillus Calmette-Guerin(ImmunityBio) 相关的转化医学

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100 项与 Bacillus Calmette-Guerin(ImmunityBio) 相关的专利（医药）

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11,357

项与 Bacillus Calmette-Guerin(ImmunityBio) 相关的文献（医药）

2025-12-31·Pulmonology

Vaccination in post-tuberculosis lung disease management: A review of the evidence

Review

作者: Rommasi, F. ; Tajabadi, Z. ; Silva, D.R. ; Solovic, I. ; Rabahi, M.F. ; Nasiri, M.J. ; Centis, R. ; van den Boom, M. ; Khelghati, F. ; Sotgiu, G. ; Sarmastzadeh, T. ; Zahmatkesh, M.M. ; D'Ambrosio, L. ; Tadolini, M. ; Marconi, L. ; Migliori, G.B. ; de Queiroz Mello, F.C. ; Pontali, E. ; Galvão, T. ; Bombarda, S. ; Tiberi, S. ; Dalcolmo, M.P.

INTRODUCTION AND OBJECTIVESPost-tuberculosis lung disease (PTLD), as other chronic respiratory disorders, may have infectious complications; some of them can be prevented with vaccinations. So far, no document has discussed the potential role of vaccination in PTLD. Therefore, the objective of this review was to describe vaccination recommendations to prevent infections potentially capable of complicating PTLD.MATERIALS AND METHODSA non-systematic review of the literature was conducted. The following keywords were used: tuberculosis, vaccination, vaccines and PTLD. PubMed/MEDLINE and Embase were used as the search engine, focusing on English-language literature only.RESULTSWe identified 9 vaccines potentially useful in PTLD. Influenza, pneumococcal and anti-COVID-19 vaccinations should be recommended. Patients with PTLD can also benefit from vaccination against shingles. Vaccination against pertussis is mainly relevant during childhood. Diphtheria, tetanus and measles vaccination are recommended for general population and should be considered in patients with PTLD not previously vaccinated. Tdap (Tetanus, diphtheria, and pertussis) booster should be repeated in every adult every ten years. Vaccination against BCG retains its importance during early childhood in countries where TB is endemic.CONCLUSIONSVaccination deserves to be considered among the strategies to prevent and/or mitigate PTLD complications. Further evidence is necessary to better understand which vaccines have the greatest impact and cost-benefit.

2025-12-01·Current Urology Reports

Management of Lower Urinary Tract Symptoms during the Treatment for Non-Muscle Invasive Bladder Cancer

Review

作者: Seiden, Benjamin ; Ajay, Divya ; Pietzak, Eugene ; Clements, Matthew ; Cheung, Felix

PURPOSE OF REVIEWThis narrative review aims to report upon the existing treatment evidence and strategies for managing lower urinary tract symptoms (LUTS) during treatment, including transurethral resection and intravesical therapy. This review also attempts to examine novel approaches to mitigate treatment-related lower urinary tract symptoms and improve treatment adherence.RECENT FINDINGSThere is sparse but promising evidence in improving LUTS secondary to intravesical therapy. Oral agents including phenazopyridine and hyaluronic acid, Bacillus Calmette-Guerin dose reduction, and emerging therapies including beta-3 agonists as well as Onabotulinumtoxin A injections all have demonstrated encouraging improvement in LUTS in limited research. Although recent literature explores new medications and potential strategies for managing intravesical therapy-related LUTS, further research is required to establish efficacy and new consensus on treatment strategies. Further research is also required to establish effective LUTS mitigation strategies with other emerging intravesical therapy regimens.

2025-12-01·Journal of Clinical Immunology

First Brazilian Case Report of Unrelated Patients with Identical ISG15 Mutation

Article

作者: Napoleao, Sarah Maria da Silva ; de Barros Dorna, Mayra ; Franca, Tabata Takahashi ; Salgado, Ranieri Coelho ; Ferreira, Janaira Fernandes Severo ; de Moura, Thais Costa Lima ; Gomes, Lillian Nunes ; Condino-Neto, Antonio ; Barreiros, Lucila Akune

BACKGROUNDISG15 deficiency is a mixed syndrome of Mendelian susceptibility to mycobacterial infections (MSMD), a rare inherited condition characterized primarily by recurrent infections from low-virulence mycobacteria and monogenic type I interferonopathy.OBJECTIVETo characterize the laboratory and molecular features of two patients from different families affected by the same ISG15 variant.METHODSWe began with clinical characterization and investigation, assessed IL-12/IFN-γ production, performed genetic characterization through WES and Sanger sequencing, conducted an in silico molecular analysis of the genetic ISG15 variant's protein impact, and utilized RNAseq for transcriptome analysis to understand pathway impacts on ISG15-deficient subjects from unrelated families.RESULTSA mutation in the ISG15 gene was identified, affecting two patients treated in different hospitals and cities in Brazil (Fortaleza and Sao Paulo), who are also members of unrelated families. Both patients showed low IFN-γ production when stimulated with BCG or BCG + IL-12. ISG15 deficiency presented with two distinct clinical phenotypes: infectious and neurological. It was identified that both patients are homozygous for the variant (c.83 T > A). Furthermore, it was observed that the mutant protein p.L28Q results in an unstable protein with increased flexibility (ΔΔG: -2.400 kcal/mol). Transcriptome analysis revealed 1321 differentially expressed genes, with significant upregulation in interferon pathways, showing higher expression in patients compared to controls.CONCLUSIONThis study describes the first reported cases in Brazil of two unrelated patients with the same ISG15 mutation c.83 T > A, exhibiting infectious features such as mycobacterial infections and systemic candidiasis, neurological findings, and skin lesions, without adverse reactions to the BCG vaccine.CLINICAL IMPLICATIONSReporting ISG15 gene mutations in Brazilian patients enhances understanding of genetic susceptibilities, guiding effective diagnostics and treatment. Identifying high-risk individuals aids clinical practices, genetic counseling, and influences public health policies. We have identified the first case in Brazil of the same ISG15 variant c.83 T > A that was identified in two unrelated patients with distinct clinical phenotypes, infectious and neurological.

项与 Bacillus Calmette-Guerin(ImmunityBio) 相关的新闻（医药）

2025-03-10

·生物探索

Nature Aging | 你的免疫系统几岁了？研究人员开发"衰老计算器"解码人体保卫战的年龄密码

引言你是否想过，自己的免疫系统可能正在以不同速度悄悄衰老？3月5日《Nature Aging》发表的突破性研究“Single-cell immune aging clocks reveal inter-individual heterogeneity during infection and vaccination”揭开了惊人真相：当我们用生日计算年龄时，体内的免疫细胞们正在上演着截然不同的"时光故事"。研究人员历时3年，分析1081名18-97岁健康人的130万个免疫细胞，首次绘制出五大免疫细胞的专属"衰老地图"——CD8+T细胞的杀伤力在50岁后断崖式下降42%，单核细胞（monocytes）的炎症因子风暴在60岁后激增3倍，而某些40岁人群的B细胞（B cells）竟保持着25岁的抗体生产效率！更颠覆认知的是，新冠重症患者的单核细胞会突然"衰老"7.8岁，相当于免疫系统经历了一场"时光地震"；而卡介苗（BCG）接种后，35%的人出现免疫细胞"逆生长"，28%的人却加速衰老8岁。这项研究不仅发明了精准度达±3.2岁的免疫年龄计算器（sc-ImmuAging），更揭示了健康监测的革命性维度：通过单细胞RNA测序（single-cell RNA sequencing）技术，研究人员发现免疫年龄差异可提前15年预警疾病风险，解释为何同龄人疫苗效果相差3倍，甚至预测长期新冠（long COVID）患者的恢复轨迹。当传统体检还在关注血压血糖时，这项突破已带我们走进细胞级抗衰老新时代——你的NK细胞（natural killer cells）能量代谢、CD4+T细胞的记忆存储能力、单核细胞的炎症调控水平，这些藏在基因表达中的数字密码，才是决定疾病抵抗力、疫苗响应度乃至寿命长度的真正标尺。免疫系统：人体最精密的安保团队也会"变老" 我们的免疫系统就像24小时待命的特种部队，B细胞（B cells）是精准狙击手，T细胞（T cells）是前线侦察兵，单核细胞（monocytes）则是快速反应部队。但最新研究发现，这支精锐部队会随着时间推移出现"职业倦怠"——65岁以上人群感染新冠后死亡率是年轻人的370倍，动脉粥样硬化等慢性炎症疾病风险激增5-8倍。最新在《自然·衰老》发表的突破性研究揭示：传统日历年龄已不能准确反映免疫系统的真实状态。通过对1081名18-97岁健康人血液样本的单细胞RNA测序（single-cell RNA sequencing），研究人员发现不同免疫细胞存在差异化的衰老轨迹。显微镜升级！单细胞技术让衰老无处遁形传统检测就像用望远镜观察星空，只能看到免疫系统的整体亮度。而单细胞技术如同哈勃望远镜，能分辨每颗"星星"的独特光芒。研究团队分析了130万个免疫细胞，发现：自然杀伤细胞（NK cells）的能量代谢相关基因表达量每十年下降12% B细胞的抗体多样性生成能力在70岁时仅剩青年期的45% CD4+T细胞（CD4+ T cells）的记忆存储功能从30岁开始每年衰退0.8% 这种精度让研究人员首次绘制出五大免疫细胞的专属"衰老地图"。比如单核细胞的NF-κB炎症通路在60岁后异常活跃，而CD8+T细胞的线粒体氧化磷酸化（oxidative phosphorylation）效率在50岁后骤降40%。 sc-ImmuAging：给免疫细胞定制的"衰老计算器" 研究团队开发的sc-ImmuAging模型，就像给每种免疫细胞配备了智能手表。这个AI系统通过机器学习（machine learning）识别出627个关键衰老标志物，包括：单核细胞的S100A8基因（炎症加速器）每十年表达量增加18% CD8+T细胞的TCF7基因（记忆形成开关）在疫苗接种后活性提升23% B细胞的XBP1基因（抗体工厂总控）在慢性感染中效率下降35% 在1081人的验证中，模型预测年龄与实际年龄相关系数达0.91（满分1），误差仅±3.2岁。更惊人的是，这个计算器能捕捉到传统检测无法发现的"隐形衰老"——某些50岁健康人的单核细胞实际年龄可能已达65岁水平。新冠患者的免疫"年龄地震"：单核细胞老10岁当这把"尺子"测量新冠患者时，发现了触目惊心的变化。重症患者的单核细胞平均衰老加速7.8岁，相当于免疫系统突然老了10年。这种"年龄地震"的震中位于： TNF信号通路活性提升3倍细胞凋亡（apoptosis）相关基因表达量翻番干扰素（interferon）应答能力下降60% 但希望在于康复过程——出院3个月后，单核细胞年龄回春4.2岁。研究跟踪的长期新冠（long COVID）患者数据显示，肺部功能受损者的免疫年龄恢复速度比常人慢40%，这解释了为何他们更易反复感染。疫苗反应现形记：有人逆龄生长，有人加速衰老在卡介苗（BCG）接种研究中，研究人员发现惊人的个体差异： 35%接种者CD8+T细胞年轻化2-5岁（免疫年龄逆生长） 28%接种者反而衰老3-8岁（疫苗效果降低60%）基线干扰素水平高者，疫苗后T细胞杀伤力提升3倍关键差异藏在基因调控网络里：逆龄组的IRF7转录因子活性提升42%，而衰老组的IRF1通路异常活跃。这就像手机系统升级——有人获得性能提升，有人却因硬件不兼容越用越卡。未来已来：定制你的免疫抗衰方案这项突破将带来三大变革：精准体检：50岁就能预知70岁时的免疫弱点疫苗定制：通过基因检测匹配最佳接种方案抗衰干预：针对特定细胞开发"年龄复位"药物有研究团队正在试验两种新策略：用二甲双胍（metformin）激活单核细胞的能量代谢，以及通过基因编辑调控TCF7基因恢复T细胞活力。免疫系统不是永动机，但它比想象中更"可塑"。未来的体检，或许就会有免疫年龄这一项，也许这就是你健康长寿的密码。参考文献 Li W, Zhang Z, Kumar S, Botey-Bataller J, Zoodsma M, Ehsani A, Zhan Q, Alaswad A, Zhou L, Grondman I, Koeken V, Yang J, Wang G, Volland S, Crişan TO, Joosten LAB, Illig T, Xu CJ, Netea MG, Li Y. Single-cell immune aging clocks reveal inter-individual heterogeneity during infection and vaccination. Nat Aging. 2025 Mar 5. doi: 10.1038/s43587-025-00819-z. Epub ahead of print. PMID: 40044970. 责编|探索君排版|探索君转载请注明来源于【生物探索】声明：本文仅用于分享，不代表平台立场，如涉及版权等问题，请尽快联系我们，我们第一时间更正，谢谢！ End 往期精选围观 Nature Biotechnology | 活细胞RNA追踪革命：CRISPR新技术首次实现天然RNA单分子实时成像热文 Nature | "分子剪刀"失控催生癌症"通用抗原" 热文 Nature | 当"保安"变成"内鬼"：GABA能神经元如何滋养致命脑瘤热文 Science | 免疫系统的“记忆库”被打开？机器学习诊断准确率逼近99% 热文 Nature | 当癌细胞开始“抱团取暖”：破解肿瘤生存的致命同盟

疫苗细胞疗法信使RNA

2025-03-03

·药时空

结核病预防：现状与未来，关乎你我的健康防线！

家人们，全球约四分之一人口感染过结核分枝杆菌，5 - 10% 会发病，结核病预防不容忽视。这篇文章带你全面了解其预防策略，关乎你我健康，快码住！传播与预防要点：结核病传播和宿主、病原体、环境密切相关。宿主高杆菌载量、长时间密切接触，病原体的谱系差异，环境的过度拥挤，都易引发传播。预防主要靠疫苗接种、感染检测和预防性治疗。疫苗：现状与新希望：卡介苗（BCG）是常用疫苗，对幼儿和重症结核有一定预防效果，但对年长人群效果不好，其复种效果也有争议。现在多种新型疫苗正在研发。像 M72:AS01E 疫苗预防肺结核的总疗效达 54%；mRNA 疫苗也进入临床试验，不过效果还需验证。检测：难题与新方向：常用的结核菌素皮肤试验（TST）和干扰素 - γ 释放试验（IGRA），都难以准确区分潜伏感染和发病状态。TST 检测不便，IGRA 价格贵，在高负担国家预测价值低。新检测方法如基于细胞因子表达谱和全血转录特征的检测有潜力，但临床应用还需研究。预防性治疗：挑战与方案：预防性治疗（TPT）能降低发病风险，短疗程方案更受欢迎，比如 1 个月的利福喷丁和异烟肼每日方案。不过在孕妇、儿童和耐多药结核病接触者中使用 TPT，还面临药物选择、安全性和有效性等问题。不同地区防控策略：低负担地区目标是在 2035 年消除结核病（发病率 < 1/10 万），要积极筛查高危人群，像移民、免疫抑制人群和 HIV 感染者。新入境筛查和个性化风险评估工具很重要。高负担地区结核病和社会经济因素关联大，社会支持和营养补充很关键，HIV 感染者和 5 岁以下儿童密切接触者应优先进行 TPT。未来展望：预防结核病要多方努力，研发更有效的疫苗、更精准的检测方法和更易获取的短疗程预防方案。全球需加强合作研究，共同对抗结核病这一健康威胁，保护大家免受侵害。家人们，这些知识关乎健康，赶紧转发到朋友圈，让更多人重视起来！

疫苗信使RNA

2025-02-20

·Pharmaceutical Technology

FDA authorises ImmunityBio’s BCG alternative to treat bladder cancer

The company holds several patents for the composition and use of BCG combined with Anktiva in bladder cancer treatment. Credit: SaiArLawKa2/Shutterstock. ImmunityBio has gained US Food and Drug Administration (FDA) authorisation for an expanded access programme to supply an alternative source of Bacillus Calmette-Guerin (BCG) to treat bladder cancer. The development comes in response to significant supply shortages of Tice BCG [an attenuated, live culture preparation of the BCG strain of Mycobacterium bovis] which have been a major barrier to treatment. In a survey of US urologists by Sermo, more than half reported an inability to treat subjects in the past 12 months due to the lack of access to Tice BCG. The Serum Institute of India-developed alternative BCG (rBCG) source has shown promising outcomes in European clinical trials, demonstrating potent immunogenicity with cluster of differentiation 8+ (CD8+) and CD4+ T cell stimulation and enhanced safety compared to previous BCG strains and formulations. ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: “Our collaboration with the FDA and Serum Institute to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio’s commitment to addressing critical access issues that affect so many patients.” In May 2024, ImmunityBio entered an exclusive global agreement with the Serum Institute of India to obtain a supply of the BCG vaccine for all types of cancer. The company holds several patents for the composition and use of BCG combined with Anktiva in bladder cancer treatment. The rBCG vaccine, originally developed as a live vaccine against tuberculosis (TB), has been used since 1921 and administered to more than four billion individuals globally. For non-muscle invasive bladder cancer (NMIBC) patients, BCG has been the standard of care since 1977, inducing an immune response that can lead to cancer clearance. The rBCG has undergone genetic modifications to enhance its immunogenicity and safety. It has completed Phase I/II human trials in Europe as an immunotherapy for NMIBC subjects, showing a safety profile similar to placebo and reduced adverse events.

疫苗免疫疗法上市批准临床研究

100 项与 Bacillus Calmette-Guerin(ImmunityBio) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AX03	DB12768

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床2期	美国	ImmunityBio, Inc.	2014-07-21

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02138734 \| NCT03022825 (Pubmed \| Future Oncol)	N/A	非肌层浸润性膀胱肿瘤	-	N-803 plus BCG	(鹹廠膚膚鏇網選淵鬱範) = 積艱構網壓膚壓範築遞艱積廠餘夢衊繭夢製鏇 (衊繭蓋夢壓遞鏇選廠夢 )	积极	2024-07-02
				BCG	(鹹廠膚膚鏇網選淵鬱範) = 繭醖鹹膚齋築顧襯網鑰艱積廠餘夢衊繭夢製鏇 (衊繭蓋夢壓遞鏇選廠夢 )
MP16-19 (AUA2024)	N/A	-	118	BCG	(膚窪獵簾夢壓遞築糧顧) = 鹽顧繭廠蓋淵鏇築鹹齋廠顧淵鏇網蓋鑰糧醖鏇 (構襯蓋網襯窪築製鑰獵 ) 更多	不佳	2024-05-01
				Gemcitabine/Docetaxel	(膚窪獵簾夢壓遞築糧顧) = 遞憲衊願淵鹽範製糧獵廠顧淵鏇網蓋鑰糧醖鏇 (構襯蓋網襯窪築製鑰獵 ) 更多
AUA2024	N/A	非肌层浸润性膀胱肿瘤	-	BACILLUS CALMETTE-GUÉRIN (BCG Induction)	淵餘鬱顧膚蓋餘壓淵鏇(醖襯遞鏇壓糧築遞遞鹹) = 鬱衊齋艱蓋積窪構遞鏇齋鏇鬱簾積觸壓構選憲 (顧選積膚構糧製繭築範 )	-	2024-05-01
PD41-09 (AUA2024)	N/A	肾盂和输尿管尿路上皮癌	59	Gemcitabine/Docetaxel	(簾觸夢衊獵簾衊膚觸網) = 積範積選範餘蓋淵範糧獵構衊糧鑰夢艱觸積衊 (艱餘鹹願獵鹽鹹構憲積 )	积极	2024-05-01
				Bacillus Calmette-Guérin (BCG)	(簾觸夢衊獵簾衊膚觸網) = 淵觸壓齋獵選範獵淵築獵構衊糧鑰夢艱觸積衊 (艱餘鹹願獵鹽鹹構憲積 )
ASCO_GU2024	N/A	肾盂和输尿管尿路上皮癌	59	Gemcitabine/Docetaxel	(鹽餘淵餘網鹽衊襯醖繭) = 願構衊鏇鹹憲淵艱選襯衊蓋繭觸選窪衊憲簾糧 (鏇襯簾築餘憲鬱獵範鹹 ) 更多	积极	2024-01-25
				BCG	(鹽餘淵餘網鹽衊襯醖繭) = 築積構窪鏇繭願鹽網廠衊蓋繭觸選窪衊憲簾糧 (鏇襯簾築餘憲鬱獵範鹹 ) 更多
AUA2023	N/A	非肌层浸润性膀胱肿瘤辅助 tumor necrosis factor α (TNFα) \| interleukin (IL)-6	-	PPD injection + BCG therapy	壓鹽製簾築壓鬱蓋餘鹹(鬱憲簾艱構襯憲膚糧鏇) = 鹹鹽鏇鑰願繭淵觸觸淵鏇積廠遞蓋鏇築鏇襯顧 (憲糧範鑰選觸範遞鏇糧 )	-	2023-04-01
				BCG therapy alone	壓鹽製簾築壓鬱蓋餘鹹(鬱憲簾艱構襯憲膚糧鏇) = 艱糧網壓築餘淵積顧鑰鏇積廠遞蓋鏇築鏇襯顧 (憲糧範鑰選觸範遞鏇糧 )
ASCO_GU2022	N/A	非肌层浸润性膀胱肿瘤	199	Prior radiotherapy	鬱積艱築醖遞夢築鑰鑰(蓋夢憲襯顧蓋夢願壓鏇) = 積窪範糧顧壓觸鏇製願願積築鹽衊顧鹽窪蓋網 (糧襯獵構鬱壓夢憲築遞 ) 更多	积极	2022-02-16
				BCG (Radical prostatectomy)	(築窪鹽窪鏇願醖選遞壓) = 蓋餘積餘窪鑰鏇繭衊憲顧觸蓋窪構簾醖襯網鏇 (鹽顧襯選蓋觸淵觸鏇餘 )
ERS2021	N/A	CD8+T lymphocytes	-	BCG revaccination	獵範蓋鹹蓋鬱網衊築鹹(醖醖鹹餘壓糧鏇憲觸壓) = 廠艱鹹窪衊壓衊壓鹽衊鏇簾齋鹽鏇製積獵淵壓 (廠淵構廠鹽觸築壓願蓋 )	积极	2021-09-05
				Placebo	獵範蓋鹹蓋鬱網衊築鹹(醖醖鹹餘壓糧鏇憲觸壓) = 築簾鏇壓築蓋襯積遞構鏇簾齋鹽鏇製積獵淵壓 (廠淵構廠鹽觸築壓願蓋 )
AUA2021	N/A	非肌层浸润性膀胱肿瘤	522	BCG (Intermediate Risk Ta tumors)	淵網蓋廠壓壓衊簾憲繭(鹽膚膚範壓製願製鏇遞) = 積淵膚膚齋選壓餘遞築餘遞醖網繭窪築獵範製 (構選襯艱淵齋製餘願艱 ) 更多	-	2021-09-01
				BCG (High Risk Ta tumors)	淵網蓋廠壓壓衊簾憲繭(鹽膚膚範壓製願製鏇遞) = 鹽觸鹹襯網艱夢鹹蓋艱餘遞醖網繭窪築獵範製 (構選襯艱淵齋製餘願艱 ) 更多
AUA2021	临床2/3期	原位癌	80	N-803 plus BCG	(遞夢壓範鑰鬱餘醖襯獵) = 製夢簾膚鑰鏇鬱鏇淵窪鬱積夢醖糧鏇鑰觸窪顧 (遞製範選襯選獵範積壓 )	积极	2021-09-01