博沃生物-成大生物13价肺炎球菌结合疫苗Ⅰ期临床研究启动暨研究者培训会成功举办

2022年10月26日，“博沃生物-成大生物13价肺炎球菌结合疫苗Ⅰ期临床研究启动暨研究者培训会”在湘潭市妇幼保健院学术交流中心成功举办。申办方武汉博沃及成大生物、CRO服务方思睦瑞科以及湖南省疾病预防控制中心、湘潭市卫健委、湘潭市疾病预防控制中心、湘潭市岳塘区卫健局、湘潭市岳塘区疾病预防控制中心、湘潭市妇幼保健院领导及项目参与人员出席了会议。

On October 26, 2022, the "BravoVax-Chengda PCV13 Phase I Clinical Research Launch and Researcher Training Meeting" was successfully held in the Academic Exchange Center of Xiangtan Maternal and Child Health Institute. The sponsor BravoVax and Chengda, CRO service provider Simoon Record, leaders and project participants of Hunan CDC, Xiangtan Municipal Health Commission, Xiangtan CDC, Xiangtan Yuetang District Health Bureau, Xiangtan Yuetang CDC and Xiangtan Maternal and Child Health Care Hospital attended the meeting.

湘潭市妇幼保健院院长曾建武为启动会致辞

曾院长表示：经过三个月的紧张筹备，博沃生物-成大生物13价肺炎球菌结合疫苗Ⅰ期临床研究终于正式启动，标志着临床研究进入实质性阶段。湘潭市妇幼保健院将全力做好临床研究服务工作，确保研究顺利开展。

Zeng Jianwu, President of Xiangtan Maternal and Child Health Hospital, delivered a speech for the kick-off meeting. President Zeng said that after three months of intense preparation, the Phase I clinical study of BravoVax-Chengda PCV13 was officially launched, marking that the clinical study has entered a substantive stage. Xiangtan Maternal and Child Health Hospital will do its best to provide clinical research services and ensure the smooth development of research.

申办方代表成大生物副总经理周荔葆表示——

成大生物立足于生物医药行业二十年，已成功开发数个疫苗项目。PCV13作为成大生物的重要疫苗项目，很荣幸能在湘潭市开启Ⅰ期临床研究，并预祝项目在各方的共同努力下取得理想的结果。

Zhou Libao, deputy general manager of Chengda on behalf of the sponsor, said that Chengda had successfully developed several vaccine projects based on the biological pharmaceutical industry for 20 years. As an important vaccine project of Chengda, PCV13 is honored to open Phase I clinical research in Xiangtan City, and wishes the project to achieve ideal results with the joint efforts of all parties.

申办方代表武汉博沃CEO吴克博士表示——

非常荣幸博沃生物第一个获得临床许可的项目在湘潭市开展Ⅰ期临床研究。博沃生物一直立足于创新疫苗的研发，公司的重组新冠疫苗已获巴西和新加坡临床批件，其它国家的临床申报工作也在同期进行。公司其他创新型疫苗，如广谱HPV疫苗、带状疱疹疫苗等也在国外开展临床申报工作。未来，博沃生物希望能陆续将更多创新类品种疫苗推向临床阶段，并且期待能与湘潭市实现更多合作。PCV13疫苗一直以来被WHO列为世界优先使用的疫苗品类，在新冠爆发之前有“疫苗之王”的美誉。相信随着PCV13疫苗临床实验的推进和成功，该疫苗能为湘潭市、湖南省、全中国以及世界的儿童免除肺炎球菌感染带来的危害做出博沃的贡献！

Dr. Wu Ke, CEO of BravoVax, on behalf of the sponsor, said that it was a great honor for BravoVax to carry out Phase I clinical research in Xiangtan City as the first project with clinical license. BravoVax has always been based on the research and development of innovative vaccines. The company's recombinant COVID-19 vaccine has obtained clinical approval documents from Brazil and Singapore, and clinical applications in other countries are also being carried out at the same time. Other innovative vaccines of the company, such as broad-spectrum HPV vaccine and herpes zoster vaccine, also carried out clinical application abroad. In the future, BravoVax hopes to push more innovative vaccines to the clinical stage, and expects to achieve more cooperation with Xiangtan City. PCV13 vaccine has been listed by WHO as the priority vaccine category in the world, and it was known as the "King of Vaccines" before the outbreak of COVID-19. It is believed that with the promotion and success of clinical trials of PCV13 vaccine, this vaccine will make a great contribution to the elimination of pneumococcal infection among children in Xiangtan City, Hunan Province, China and the world!

CRO服务方代表思睦瑞科总经理韦鹏翀表示——

增加13价肺炎疫苗的国产供给，实现国产替代，是发展民族生物产业的重要战略。未来我们也将通过“一带一路”倡议，将13价肺炎疫苗服务更多国家的儿童。思睦瑞科为承接该项目临床相关工作感到十分荣幸，公司将严格按照国际人用药品注册技术协调会（ICH）的GCP要求，执行本次研究的CRO服务工作。

Wei Pengchong, the general manager of the Simoon Record, said that increasing the domestic supply of PCV13 and realizing domestic substitution were important strategies for the development of national biological industry. In the future, we will also use the PCV13 to serve children in more countries through the "the Belt and Road" initiative. Simoon Record is very honored to undertake the clinical related work of this project. The company will strictly follow the GCP requirements of ICH to perform the CRO service of this study.

湖南省疾病预防控制中心党委副书记王庆波表示——

疫情防控期间，临床实验的开展要严格遵守疫情防控规定做好各项工作。他特别指出，该项目的受众人群主要是儿童，风险管控和产品质控是重中之重。

Wang Qingbo, Deputy Secretary of the Party Committee of the Hunan CDC, said that during the epidemic prevention and control period, clinical experiments should be carried out in strict accordance with the epidemic prevention and control regulations. He particularly pointed out that the target group of the project was mainly children, thus risk control and product quality control were the top priorities.

会议最后，湖南省疾控中心领导和湘潭市卫健委领导共同宣布项目启动。

At the end of the meeting, leaders of the Hunan CDC and Xiangtan Municipal Health Commission jointly announced the launch of the project.

博沃生物-成大生物13价肺炎球菌结合疫苗Ⅰ期临床研究项目启动和落地，标志着博沃生物PCV13疫苗的研究工作迈入了新征程。博沃生物将与主要研究者、CRO服务方一道，稳步推进临床工作，同时继续加快其它新型疫苗产品管线的研究和临床申报工作，为健康预防事业持续贡献博沃力量。

The launch and implementation of Phase I clinical research project of BravoVax-Chengda PCV13 marked a new journey in the research of BravoVax PCV13. BravoVax will work with major researchers and CRO service providers to steadily promote clinical work, while continuing to speed up the research and clinical application of other innovative vaccine product pipelines, and continue to contribute to the health prevention cause.