Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a leading maker of human vaccines and therapeutic biologics, has announced the successful conclusion of a Phase II clinical study for its herpes zoster vaccine, LZ901. The drug demonstrated statistically and clinically meaningful data, along with a good safety profile. The company is now progressing to a multi-center, randomized, double-blind, and placebo-controlled Phase III study for the vaccine in China.
LZ901: A Recombinant Herpes Zoster Vaccine for Adults
LZ901 is an in-house developed recombinant herpes zoster vaccine designed to prevent herpes zoster caused by the varicella zoster virus in adults aged 50 and above. The vaccine is based on the mechanism of the human immune system’s processing of foreign antigens, aiming to prevent the occurrence of herpes zoster and related complications, including postherpetic neuralgia.
Phase II Study Design and Outcomes
The Phase II study was designed to assess the immunogenicity, safety, and immune persistence of the vaccine in healthy populations aged 50 to 70, enrolling 450 patients. The study found that the geometric mean concentration (GMC), geometric mean titer (GMT), and positive conversion rate of antibodies in the LZ901 high-dose group were significantly higher than those in the low-dose group. Moreover, the antibody GMC, GMT, and positivity rate in both the high-dose and low-dose groups of LZ901 were significantly higher than those in the placebo group, indicating a strong immune response to the vaccine.-Fineline Info & Tech
