北京科兴腸病毒疫苗成人臨床初步結果安全 進入幼兒收案

Sinovac releases Phase I clinical trial results of EV71 vaccine

PBR Staff Writer Published 11 March 2011  Sinovac Biotech has released the Phase I clinical trial results for the adult population for its proprietary inactivated vaccine against human enterovirus 71 (EV71), which causes hand, foot and mouth disease (HFMD). The preliminary Phase I results for the EV71 vaccine in adults showed a good safety profile and preliminary immunogenicity profile. Sinovac subsequently initiated the inoculations in the young children and infant groups. The Phase I design is a single center, randomization, double blinded, and placebo controlled study, which enrolls 168 healthy volunteers in three different groups: adults, young children and infants. The study will evaluate the safety and preliminary immunogenicity profile in the different age groups. The Phase I clinical trial is being conducted in the adult group first and followed by the young children group and then the infant group, starting with a lower dosage followed by a higher dosage. Sinovac chairman and CEO Weidong Yin said these initial results showed no severe adverse events and demonstrated a positive safety and tolerance profile in the adult population. "We were pleased to complete the enrollment, inoculations and safety observation of this first group in just two months and recently commenced administering the EV71 vaccine to the healthy volunteers in the young children and infant groups and we will continue to advance the Phase I trial in the coming months and to provide additional updates on our progress," Yin said.