Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S)(Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S))

概要

基本信息

药物类型

溶瘤细菌

别名

VesiCulture

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

膀胱癌

非在研适应症-

原研机构

Aj Vaccines A/S

在研机构

Aj Vaccines A/S

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) 相关的临床试验

EUCTR2020-001783-28-HU

/ Not yet recruiting临床3期IIT

REDUCING ABSENCE FROM WORK OF HEALTHCARE WORKERS DUE TO COVID-19 INFECTION BY BCG (BACILLUS CALMETTE-GUÉRIN) VACCINATION - BACH (BCG Against COVID-19 in Hunga

开始日期2020-05-06

申办/合作机构-

NCT04165317

/ Active, not recruiting临床3期

A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).
In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.
* One group is given sasanlimab and BCG at the study clinic.
* The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
* The third group is given BCG only and will not receive sasanlimab.
In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.
- Both groups will be given sasanlimab at the study clinic.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

开始日期2019-12-30

申办/合作机构

Pfizer Inc.

ACTRN12618001936213

/ Not yet recruitingN/AIIT

Safety study of Bacille-Calmette-Guerin (BCG) for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy(MADSAM).

开始日期2019-04-01

申办/合作机构

Sydney Local Health District

100 项与 Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) 相关的临床结果

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100 项与 Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) 相关的转化医学

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100 项与 Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) 相关的专利（医药）

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313

项与 Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) 相关的文献（医药）

2025-02-01·European Journal of Pharmaceutical Sciences

Intradermal versus subcutaneous immunization: Effects of administration route using a lipid-PLGA hybrid nanoparticle tuberculosis vaccine

Article

作者: Geluk, A ; Bouwstra, J A ; van den Eeden, S J F ; Szachniewicz, M M ; van Meijgaarden, K E ; Franken, K L M C ; van Veen, S ; Ottenhoff, T H M

Tuberculosis (TB) remains a significant global health challenge, latently affecting around a quarter of the global population. The sole licensed TB vaccine, Mycobacterium bovis Bacillus Calmette-Guérin (BCG), shows variable efficacy, particularly among adolescents and adults, underscoring the pressing need for more effective vaccination strategies. The administration route is crucial for vaccine efficacy, and administration via the skin, being rich in immune cells, may offer advantages over conventional subcutaneous routes, which lack direct access to abundant antigen-presenting cells. This study compared the immunogenic effects of intradermal versus subcutaneous administration of a candidate TB vaccine delivering a Ag85B-ESAT6-Rv2034 (AER) multiphase fusion recombinant protein, in lipid-poly(D,L-lactic-co-glycolic acid) (lipid-PLGA) nanoparticles in mice. In-depth evaluation of immune responses in splenocytes was performed using 27-marker spectral flow cytometry. Both routes elicited significant T-cell responses. However, intradermal administration uniquely increased polyfunctional CD4⁺ and CD8⁺ T-cells producing IL-2, IFNγ, and TNFα, associated with protection against TB. Additionally, it significantly increased CD69⁺ B-cell counts and induced higher AER-specific antibody titers, particularly IgG2a. These results underscore the superior immunogenic potential of intradermal vaccine administration by effectively inducing immune cells associated with TB protection, highlighting its significance in the development of new vaccine strategies.

2024-12-31·Human Vaccines & Immunotherapeutics

Saponin TQL1055 adjuvant-containing vaccine confers protection upon Mycobacterium tuberculosis challenge in mice

Article

作者: Ahmed, Mushtaq ; Swanson, Rosemary V. ; Farris, Eric ; Martin, Tyler ; Khader, Shabaana A. ; Das, Shibali ; Yang, Yan

Tuberculosis (TB), caused by the intracellular pathogen Mycobacterium tuberculosis (Mtb), affects the lungs of infected individuals (pulmonary TB) but can also affect other sites (extrapulmonary TB). The only licensed vaccine Mycobacterium bovis bacillus Calmette-Guerin (BCG) protects infants and young children but exhibits variable efficacy in protecting against adult pulmonary TB. Poor compliance and prolonged treatment regimens associated with the use of chemotherapy has contributed to the development of multidrug-resistant (MDR) and extensively drug-resistant (XDR) Mtb. Thus, there is an urgent need for the design of more effective vaccines against TB. The development of safe and novel adjuvants for human use is critical. In this study, we demonstrate that saponin-based TQL1055 adjuvant when formulated with a TLR4 agonist (PHAD) and Mtb specific immunodominant antigens (ESAT-6 and Ag85B) and delivered intramuscularly in mice, the SA-TB vaccine induced potent lung immune responses. Additionally, the SA-TB vaccine conferred significant protection against Mtb infection, comparable with levels induced by BCG. These findings support the development of a SA-TB vaccine comprising TQL1055, as a novel, safe and effective TB vaccine for potential use in humans.

2024-12-01·International Journal of Pharmaceutics

Evaluation of PLGA, lipid-PLGA hybrid nanoparticles, and cationic pH-sensitive liposomes as tuberculosis vaccine delivery systems in a Mycobacterium tuberculosis challenge mouse model – A comparison

Article

作者: Geluk, Annemieke ; Franken, Kees L.M.C. ; Limpens, Ronald W A L ; van Veen, Suzanne ; van den Eeden, Susan J F ; Franken, Kees L M C ; Ottenhoff, Tom H M ; van Veen, S. ; van Meijgaarden, Krista E ; Neustrup, Malene A ; Szachniewicz, M.M. ; Bouwstra, J.A. ; Szachniewicz, Mikołaj M ; Neustrup, M.A. ; van den Eeden, S.J.F. ; Koning, R.I. ; Limpens, R.W.A.L. ; Koning, Roman I ; van Meijgaarden, K.E. ; Geluk, A. ; Bouwstra, Joke A ; Ottenhoff, T.H.M.

Tuberculosis (TB) continues to pose a global threat for millennia, currently affecting over 2 billion people and causing 10.6 million new cases and 1.3 million deaths annually. The only existing vaccine, Mycobacterium Bovis Bacillus Calmette-Guérin (BCG), provides highly variable and inadequate protection in adults and adolescents. This study explores newly developed subunit tuberculosis vaccines that use a multistage protein fusion antigen Ag85b-ESAT6-Rv2034 (AER). The protection efficacy, as well as in vivo induced immune responses, were compared for five vaccines: BCG; AER-CpG/MPLA mix; poly(D,L-lactic-co-glycolic acid) (PLGA); lipid-PLGA hybrid nanoparticles (NPs); and cationic pH-sensitive liposomes (the latter three delivering AER together with CpG and MPLA). All vaccines, except the AER-adjuvant mix, induced protection in Mycobacterium tuberculosis (Mtb)-challenged C57/Bl6 mice as indicated by a significant reduction in bacterial burden in lungs and spleens of the animals. Four AER-based vaccines significantly increased the number of circulating multifunctional CD4⁺ and CD8⁺ T-cells producing IL-2, IFNγ, and TNFα, exhibiting a central memory phenotype. Furthermore, AER-based vaccines induced an increase in CD69⁺ B-cell counts as well as high antigen-specific antibody titers. Unexpectedly, none of the observed immune responses were associated with the bacterial burden outcome, such that the mechanism responsible for the observed vaccine-induced protection of these vaccines remains unclear. These findings suggest the existence of non-classical protective mechanisms for Mtb infection, which could, once identified, provide interesting targets for novel vaccines.

100 项与 Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) 相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
膀胱癌	丹麦	Aj Vaccines A/S	-

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临床结果

适应症

分期

评价

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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


ASCO_GU2011	N/A	非肌层浸润性膀胱肿瘤	162	bacillus Calmette-Guerin (BCG) (Group A (immediate post-TUR MMC instillation))	(顧鏇範鬱鹽繭憲壓襯觸) = 遞選齋鏇艱窪廠糧範繭遞膚憲衊製範顧鏇襯襯 (餘窪鬱顧憲蓋艱遞膚觸 ) 更多	-	2011-03-01
				bacillus Calmette-Guerin (BCG) (Group B (TUR and BCG instillation only))	(顧鏇範鬱鹽繭憲壓襯觸) = 憲窪選築製構壓簾衊衊遞膚憲衊製範顧鏇襯襯 (餘窪鬱顧憲蓋艱遞膚觸 ) 更多
ASCO2008	N/A	膀胱原位癌	108	Passive diffusion mitomycin-C (PD/MMC)	醖獵願顧壓製壓窪鏇觸(遞築糧鬱廠鏇齋鹽鏇網) = 築夢衊夢遞鏇糧醖艱願壓製獵繭構廠積襯範積 (淵醖繭淵襯觸選鹹構繭 ) 更多	-	2008-05-20
				Electromotive/mitomycin-C (EMDA/MMC)	醖獵願顧壓製壓窪鏇觸(遞築糧鬱廠鏇齋鹽鏇網) = 選窪襯網糧憲醖淵築膚壓製獵繭構廠積襯範積 (淵醖繭淵襯觸選鹹構繭 ) 更多