Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination).

开始日期2021-02-16

申办/合作机构

St. Petersburg Research Institute of Vaccines and Sera

NCT05312294 / Completed临床3期IIT

Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years

Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M® Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with preservative) in volunteers aged between 18 and 60

开始日期2020-12-07

申办/合作机构

St. Petersburg Research Institute of Vaccines and Sera

NCT05457894 / Completed临床3期IIT

Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women During the 2nd - 3rd Trimester

Comparative study of tolerability, reactogenicity, safety and immunogenicity Flu-M [Inactivated Split Influenza Vaccine] vs. the Ultrix® vaccine for the prevention of influenza in pregnant women in the 2nd-3rd trimesters of pregnancy

开始日期2020-01-23

申办/合作机构

St. Petersburg Research Institute of Vaccines and Sera

100 项与 4-valent inactivated split influenza vaccine(St. Petersburg Research Institute of Vaccines and Sera) 相关的临床结果

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100 项与 4-valent inactivated split influenza vaccine(St. Petersburg Research Institute of Vaccines and Sera) 相关的转化医学

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100 项与 4-valent inactivated split influenza vaccine(St. Petersburg Research Institute of Vaccines and Sera) 相关的专利（医药）

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项与 4-valent inactivated split influenza vaccine(St. Petersburg Research Institute of Vaccines and Sera) 相关的文献（医药）

2024-11-01·Journal of Thrombosis and Haemostasis

Evaluating clinically translatable conditioning for platelet gene therapy in murine hemophilia A with inhibitors

Article

作者: Li, Jing ; Jing, Weiqing ; Chen, Yingyu ; Shi, Qizhen ; Schroeder, Jocelyn A

BACKGROUNDPlatelet gene therapy is effective in hemophilia A (HA) mice even with inhibitors. Fludarabine (Flu), along with busulfan (Bu) or melphalan (Mel), preconditioning has been shown to be highly effective for hematopoietic stem cell transplantation in the clinic.OBJECTIVESTo evaluate the efficacy of Bu-Flu and Mel-Flu preconditioning in platelet gene therapy of HA with inhibitors.METHODSBu-Flu and Mel-Flu were used to condition HA mice preimmunized with recombinant human factor (F)VIII. An optimal 660 centigray total body irradiation was used as a control regimen in parallel. Platelet-FVIII expression was introduced by transplantation of 2bF8 lentivirus (LV)-transduced hematopoietic stem cells. Animals were analyzed by fluorescence-activated cell sorting, quantitative polymerase chain reaction, FVIII assays, and tail bleeding tests.RESULTSBu-Flu, but not Mel-Flu, enabled successful 2bF8 gene therapy. All recipients achieved >55% chimerism post hematopoietic stem cell transplantation in both Bu-Flu and 660 centigray groups, with comparable copy numbers of 2bF8 cassette and the platelet-FVIII levels. The bleeding phenotype was rescued in 2bF8LV-transduced recipients. FVIII inhibitor titers declined with time, with comparable disappearance time of inhibitors between the 2 groups. When animals were rechallenged with recombinant human FVIII after the titers dropped to undetectable levels, no inhibitors were detected in 2bF8LV-transduced recipients. In contrast, all untransduced transplanted control mice produced inhibitors. These data demonstrate that immune tolerance was established in 2bF8LV-transduced primed HA mice under Bu-Flu conditioning.CONCLUSIONBu-Flu preconditioning allows for successfully introducing platelet-FVIII expression to restore hemostasis and induce immune tolerance in primed HA mice, suggesting that this approach is a promising clinically translatable strategy for gene therapy of HA with inhibitors.

2024-01-01·British Journal of Haematology

Busulfan–fludarabine‐ or treosulfan–fludarabine‐based conditioning before allogeneic HSCT from matched sibling donors in paediatric patients with sickle cell disease: A study on behalf of the EBMT Paediatric Diseases and Inborn Errors Working Parties

Letter

作者: Wynn, Robert ; Biffi, Alexandra ; Aljurf, Mahmoud ; Saccardi, Riccardo ; Garwer, Birgit ; Ifversen, Marianne ; Sundin, Mikael ; Lankester, Arjan C ; Peters, Christina ; de la Fuente, Josu ; Belendez, Cristina ; Galimard, Jacques-Emmanuel ; Corbacioglu, Selim ; Lawson, Sarah ; Sengeloev, Henrik ; Cseh, Annamária ; Locatelli, Franco ; Zecca, Marco ; Balduzzi, Adriana ; Isgro, Antonella

How important is choice of conditioning regimen in allogeneic haematopoietic stem cell transplantation (HSCT) for sickle cell disease (SCD)? We compared HSCT outcomes by conditioning regimen in paediatric patients with SCD from the EBMT registry. In 2010-2020, 251 patients aged <18 years underwent a first matched sibling donor (MSD) HSCT with conditioning based on busulfan-fludarabine (bu-flu; n = 89) or treosulfan-fludarabine (treo-flu; n = 162). In the bu-flu and treo-flu groups, 51.7% and 99.4% of patients, respectively, received thiotepa. Median follow-up was 2.7 years. Two-year overall survival (OS) was 98.7% (95% confidence interval [CI]: 90.9-99.8) with bu-flu and 99.3% (95% CI: 95.2-99.9) with treo-flu (p = 0.63). Grade III-IV acute graft-versus-host disease (GVHD) at 100 days was 2.4% (95% CI: 0.4-7.5) and 0.6% (0.1%-3.2%) for bu-flu and treo-flu respectively (p = 0.25). The 2-year incidence of extensive chronic GVHD was 1.5% (95% CI: 0.1-7.3) with bu-flu and 8.0% (95% CI: 4.1-13.3) with treo-flu (p = 0.057). These multinational data confirm the excellent curative capacity of MSD HSCT with myeloablative conditioning. Both conditioning regimens yielded excellent OS, low rates of acute and chronic GVHD, and low rates of graft failure.

2023-08-17·Molecules (Basel, Switzerland)

Different Size Formulations of Fluopyram: Preparation, Antifungal Activity, and Accumulation in the Fungal Pathogen Botrytis cinerea.

Article

作者: Wu, Xuemin ; Chen, Dong ; Li, Haiyun ; Xu, Yong ; Zhang, Sida ; Zhang, Ruihua ; Wang, Yinmin ; Xu, Jianfu

Nanotechnology is revolutionizing the efficient production and sustainable development of modern agriculture. Understanding the pesticide activity of both nano- and conventional methods is useful for developing new pesticide formulations. In this study, three solid fluopyram formulations with varying particle sizes were developed, and the mechanisms underlying the difference in the antifungal activity among these formulations were investigated. Wet media milling combined with freeze drying was used to prepare fluopyram nanoparticles (FLU-NS) and a micron-sized solid formulation (FLU-MS), and a jet grinding mill was employed to fabricate fluopyram wettable powder (FLU-WP). The mean particle sizes of FLU-NS, FLU-MS, and FLU-WP were 366.8 nm, 2.99 μm, and 10.16 μm, respectively. Notably, FLU-NS displayed a toxicity index against Botrytis cinerea (gray mold) that was approximately double those of FLU-MS and FLU-WP. Similar trends were noticed in the antifungal tests on Alternaria solani. The uptake of FLU-NS by B. cinerea was approximately twice that of FLU-MS and FLU-WP, indicating that fluopyram nanoparticles are more easily taken up by the pathogen (B. cinerea), and display better bioactivity than the larger fluopyram particles. Therefore, the nanosizing of pesticides appears to be a viable strategy to enhance efficiency without increasing the amount of pesticide used.

100 项与 4-valent inactivated split influenza vaccine(St. Petersburg Research Institute of Vaccines and Sera) 相关的药物交易

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