A Single-arm, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Vector) for Inhalation in People 21 to 65 Years Old (Previously Primed With Authorized Vaccines)

In this trial, a single-arm, open-label study design will be used to evaluate the safety and tolerability after vaccination with escalating doses of the investigational vaccine (Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation, RCVi) at low, medium, and high doses in healthy adults (previously primed with authorized vaccines).

开始日期2023-06-01

申办/合作机构

武汉博沃生物科技有限公司

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100 项与 Recombinant COVID-19 Vaccine(Wuhan BravoVax Co., Ltd.) 相关的临床结果

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100 项与 Recombinant COVID-19 Vaccine(Wuhan BravoVax Co., Ltd.) 相关的转化医学

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100 项与 Recombinant COVID-19 Vaccine(Wuhan BravoVax Co., Ltd.) 相关的专利（医药）

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项与 Recombinant COVID-19 Vaccine(Wuhan BravoVax Co., Ltd.) 相关的文献（医药）

2018-06-01·Journal of Cardiovascular Translational Research3区 · 医学

Retrograde Coronary Venous Infusion as a Delivery Strategy in Regenerative Cardiac Therapy: an Overview of Preclinical and Clinical Data

3区 · 医学

Review

作者: van der Naald, Mira ; Gathier, Wouter A ; Doevendans, Pieter A ; van Slochteren, Frebus J ; Chamuleau, Steven A J ; van Ginkel, Dirk Jan

An important aspect of cell therapy in the field of cardiac disease is safe and effective delivery of cells. Commonly used delivery strategies such as intramyocardial injection and intracoronary infusion both present with advantages and disadvantages. Therefore, alternative delivery routes are explored, such as retrograde coronary venous infusion (RCVI). Our aim is to evaluate safety and efficiency of RCVI by providing a complete overview of preclinical and clinical studies applying RCVI in a broad range of disease types and experimental models. Available data on technical and safety aspects of RCVI are incomplete and insufficient. Improvement of cardiac function is seen after cell delivery via RCVI. However, cell retention in the heart after RCVI appears inferior compared to intracoronary infusion and intramyocardial injection. Adequately powered confirmatory studies on retention rates and safety are needed to proceed with RCVI in the future.

BMJ Open Science

Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

Article

作者: Doevendans, Pieter A ; Chamuleau, Steven Aj ; van der Naald, Mira ; Sluijter, Joost Pg ; Gathier, Wouter A ; Neef, Klaus ; van Klarenbosch, Bas R ; van Slochteren, Frebus J ; Bemelmans, John Lm ; Tuinenburg, Anton E

BACKGROUNDCommonly used strategies for cell delivery to the heart are intramyocardial injection and intracoronary (IC) infusion, both having their advantages and disadvantages. Therefore, alternative strategies, such as retrograde coronary venous infusion (RCVI), are explored. The aim of this confirmatory study was to compare cardiac cell retention between RCVI and IC infusion. As a secondary end point, the procedural safety of RCVI is assessed.METHODSFour weeks after myocardial infarction, 12 pigs were randomised to receive mesenchymal stromal cells, labelled with Indium-111, via RCVI (n=6) or IC infusion (n=6). Four hours after cell administration, nuclear imaging was performed to determine the number of cells retained in the heart both in vivo and ex vivo. Procedure-related safety measures were reported.RESULTSCardiac cell retention is significantly lower after RCVI compared with IC infusion (in vivo: RCVI: median 2.89% vs IC: median 13.74%, p=0.002, ex vivo: RCVI: median 2.55% vs IC: median 39.40%, p=0.002). RCVI led to development of pericardial fluid and haematomas on the frontal wall of the heart in three cases. Coronary venous dissection after RCVI was seen in three pigs, of which one also developed pericardial fluid and a haematoma. IC infusion led to no flow in one pig.CONCLUSIONRCVI is significantly less efficient in delivering cells to the heart compared with IC infusion. RCVI led to more procedure-related safety issues than IC infusion, with multiple cases of venous dissection and development of haematomas and pericardial fluid collections.

100 项与 Recombinant COVID-19 Vaccine(Wuhan BravoVax Co., Ltd.) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床1期	新加坡	BravoBio Co. Ltd.	2023-06-01
新型冠状病毒感染	临床1期	新加坡	武汉博沃生物科技有限公司	2023-06-01