Bovax Recombinant EV71 Vaccine Phase I Clinical Trial Officially Started

Currently,the Recombinant Enterovirus 71 Vaccine (Hansenula polymorpha) independently developed by Bovax has initiated the Phase I clinical trial. The first subject has been successfully enrolled on October 24 at the Center for Disease Control and Prevention of the Rongshui Miao Autonomous County, Liuzhou, Guangxi Zhuang Autonomous Region. This clinical trial aims to evaluate the safety and tolerance of different doses of the candidate vaccine in Chinese healthy individuals of aged 6 to 71 months, as well as conduct the exploratory study on immunogenicity. The Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention is the responsible organization for the clinical trial, with the Head of Center MO Zhaojun serving as the principal investigator. The initial meeting and training session for this project were attended by Director LI Rongcheng, the special guest, Mr. ZHANG Gaoxia, the general manager of Bovax, and deputy director FENG Jiping, the member of the party organization of Rongshui County Health Bureau.

EV71 is an RNA virus belonging to the Enterovirus genus in the Picornaviridae family, with 4 kinds of capsid proteins (VP1~4) and 7 kinds of non-structural proteins. EV71 is one of the main pathogens causing hand-foot-and-mouth disease (HFMD). In China, children under the age of 5 have a high incidence of HFMD, accounting for 96.4% of all cases, where cases of children under the age of 3 accounting for about 82.9% of the number of cases in high-risk group. Due to its highly neurotropic nature, EV71 is the cause for most severe and fatal cases of HFMD and poses a significant threat to public health. The National Health Commission (formerly the Ministry of Health) officially classified HFMD as a Class C infectious disease on May 2, 2008. However, currently there is no specific treatment for HFMD and other EV71-related diseases. Therefore, the development and use of vaccines is the primary method for preventing and controlling HFMD.

        Up to now, there are three domestically marketed EV71 vaccine, all of them are inactivated vaccines. The Recombinant Enterovirus 71 Vaccine (Hansenula polymorpha),developed by Bovax using genetic recombination, is made by expressing capsid protein precursor P1 and non-structural protein 3CD of Enterovirus 71 (EV71) in Hansenula polymorpha. The precursor protein P1 is then split into VP0, VP1, and VP3 by 3CD. These 3 types of capsid proteins form Virus-Like Particles (VLPs) in Hansenula polymorpha, which are then purified and adsorbed with aluminium hydroxide adjuvant, eventually forming the vaccine with advantages of high safety, low cost, and large production capacity. Bovax is actively promoting clinical trials of the recombinant EV71 vaccine, and aims to make significant contributions to public health in China.