复星雅立峰冻干人用狂犬病疫苗（Vero细胞）启动IV期临床 适应症为预防狂犬病

Core Viewpoint - The clinical trial for the lyophilized human rabies vaccine (Vero cells) developed by Fosun Yalifeng (Dalian) Biopharmaceutical Co., Ltd. has been initiated to evaluate its immunogenicity, safety, and durability of immunity in individuals aged 10 to 60 years [1][2]. Group 1: Clinical Trial Details - The clinical trial is a randomized, open-label Phase IV study with the registration number CTR20255254, first publicly disclosed on January 12, 2026 [1]. - The primary objective is to assess the durability of immunity after a 4-dose and 5-dose primary immunization schedule, as well as the immunogenicity and safety of a 2-dose booster [1][2]. - The trial aims to enroll 480 participants, and it is currently ongoing but has not yet started recruitment [2]. Group 2: Vaccine Specifications - The vaccine is an injectable formulation with a specification of 0.5 mL per dose, and the potency must not be less than 2.5 IU [1]. - The administration method is intramuscular injection into the deltoid muscle, with a dosage of 0.5 mL per person per injection [1]. Group 3: Disease Context - Rabies is an acute infectious disease caused by the rabies virus, primarily transmitted through animal bites, with a near 100% fatality rate once symptoms appear [1].