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2

项与 Sumagen Co., Ltd. 相关的药物

rVSV-msp-SF-Gtc

靶点

SARS-CoV-2 E protein x SARS-CoV-2 S protein

作用机制

SARS-CoV-2 E protein抑制剂 [+1]

在研机构-

原研机构

Sumagen Co., Ltd.

在研适应症-

非在研适应症

冠状病毒感染

最高研发阶段无进展

首次获批国家/地区-

首次获批日期-

HIV-1 vaccine(Western University)

靶点-

作用机制

免疫刺激剂

在研机构-

原研机构

Western University

在研适应症-

非在研适应症

HIV感染

最高研发阶段无进展

首次获批国家/地区-

首次获批日期-

1

项与 Sumagen Co., Ltd. 相关的临床试验

NCT01546818 / Completed临床1期

A Phase I, Randomized, Observer-blinded, Placebo-controlled Clinical Study to Assess the Safety, Tolerability, and Immune Response of Killed-Whole HIV-1 Vaccine (SAV001-H) Administered Intramuscularly to Chronic HIV-1 Infected Patients Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)

The purpose of this study is to examine the safety, tolerability, and immune response to killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected individuals.

开始日期2012-03-01

申办/合作机构

Sumagen Co., Ltd.

100 项与 Sumagen Co., Ltd. 相关的临床结果

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0 项与 Sumagen Co., Ltd. 相关的专利（医药）

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2

项与 Sumagen Co., Ltd. 相关的文献（医药）

2024-07-01·Archives of Toxicology

Genotoxicity and safety pharmacology of the rVSVInd(GML)-mspSGtc vaccine against SARS-CoV-2 in Sprague–Dawley rats and Beagle dogs

Article

作者: Park, Sang-Jin ; Son, Hwa-Young ; Back, Seng-Min ; Han, Kang-Hyun ; Kwak, Chaewon ; Lee, Jeong Hwa ; Seo, Joung-Wook ; Lee, Young Ju ; Kim, Yong-Bum ; Park, Heeseon ; Kim, Dabi

The emergence of coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to a pandemic, prompting rapid vaccine development. Although vaccines are effective, the occurrence of rare adverse events following vaccination highlights the necessity of determining whether the benefits outweigh the risks posed by the infection itself. The recombinant Vesicular Stomatitis Virus (rVSV) platform is a promising vector for vaccines against emerging viruses. However, limited studies have evaluated the genotoxicity and safety pharmacology of this viral vector vaccine, which is crucial to ensure the safety of vaccines developed using this platform. Hence, the present study aimed to assess the genotoxicity and safety pharmacology of the rVSVInd(GML)-mspSGtc COVID-19 vaccine using micronucleus and comet assays, as well as neurobehavioral, body temperature, respiratory, and cardiovascular assessments in Sprague-Dawley rats and beagle dogs. The intramuscular administration of rVSVInd(GML)-mspSGtc at doses up to 1.5 × 10⁹ PFU/animal did not increase the number of bone marrow micronucleated polychromatic erythrocytes or cause liver DNA damage. Additionally, it had no significant impact on neurobehavioral functions in rats and showed marginal temporary changes in body temperature, respiratory rate, heart rate, and electrocardiogram parameters in rats and dogs, all of which resolved within 24 h. Overall, following genotoxicity and pharmacological safety assessments, rVSVInd(GML)-mspSGtc displayed no notable systemic adverse effects in rats and dogs, suggesting its potential as a vaccine candidate for human clinical trials.

2023-11-01·Vaccine

Nonclinical safety assessment and immunogenicity of rVSVInd(GML)-mspSGtc vaccine for SARS-CoV-2 in rabbits

Article

作者: Jang, Min Seong ; Choi, Jung-Ah ; Son, Hwa-Young ; Choi, Eunsil ; Kim, Yong-Bum ; Park, Heeseon ; Kim, Na Hyung ; Kim, Woojin ; Han, Kang-Hyun

The worldwide health, economic, and societal consequences of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic have been devastating. The primary strategy to prevent new infectious diseases is to vaccinate the majority of people worldwide. However, the significant hurdles that are faced include vaccine safety concerns and vaccine reluctance. Among the various types of vaccines, the recombinant vesicular stomatitis virus (rVSV) is a promising candidate owing to its safety and efficacy. Therefore, we investigated the toxicity, immunogenicity, and local tolerance of the rVSVInd(GML)-mspSGtc vaccine against SARS-CoV-2. New Zealand White (NZW) rabbits were administered single or three repeated intramuscular injections of rVSVInd(GML)-mspSGtc every 2 weeks, followed by a 4-week recovery period. Male and female rabbits were randomly assigned into three groups: a control group and two dose-level groups (1 × 10⁹ and 4 × 10⁹ PFU/mL). Treatment-related changes included a temporary increase in body temperature and local inflammation at the injection site. These findings indicated recovery or a trend toward recovery, with no overt systemic toxicity. Immunogenicity analysis results suggested that rVSVInd(GML)-mspSGtc elicited a robust dose-dependent immune response in terms of neutralizing antibodies and IgG antibodies against the SARS-CoV-2 spike protein. In addition, the immune response intensity was increased by repeated vaccine administration. In conclusion, both the approximate lethal dose and the no observed adverse effect level for rVSVInd(GML)-mspSGtc exceeded 4 × 10⁹ PFU/mL in NZW rabbits. Overall, rVSVInd(GML)-mspSGtc induced no adverse effects at the maximum dosage tested; however, its efficacy warrants further clinical evaluation.

100 项与 Sumagen Co., Ltd. 相关的药物交易

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100 项与 Sumagen Co., Ltd. 相关的转化医学

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当前项目

药物(靶点)	适应症	全球最高研发状态

rVSV-msp-SF-Gtc ( SARS-CoV-2 E protein x SARS-CoV-2 S protein )	冠状病毒感染更多	无进展
HIV-1 vaccine(Western University)	HIV感染更多	无进展