recombinant herpes zoster vaccine (LZ901) / Chongqing Zhifei - LARVOL DELTA

A randomized, blind design clinical trial evaluating the immunogenicity and safety of the recombinant herpes zoster vaccine (CHO cells) LZ901 compared with a similar positive vaccine in people 50 years of age and older (ChiCTR) - P3 | N=300 | Completed | Sponsor: Jiangsu Provincial Center for Disease Control and Prevention(Jiangsu Provincial Academy of Preventive Medicine); Beijing Luzhu Biotechnology Co.,Ltd. | Not yet recruiting ➔ Completed | Phase classification: P1 ➔ P3

Phase classification • Trial completion • Herpes Zoster • Varicella Zoster • CD40LG

Immunogenicity and safety of a recombinant gE-Fc fusion protein subunit vaccine for herpes zoster in adults ≥50 years of age: a randomised, active-controlled, non-inferiority trial. (PubMed, Nat Commun) - P1 | "Adverse reactions were markedly lower with LZ901 (41.1% [62/151] vs 87.9% [131/149]; p < 0.0001), including grade 3 events (0.7% [1/151] vs 6.0% [9/149]). LZ901 induced superior cellular immunogenicity and exhibited a better safety profile than HZ/su in adults ≥50 years, supporting its potential as a promising HZ prevention candidate vaccine."

Head-to-Head • Journal • Herpes Zoster • Varicella Zoster • CD40LG • CD8 • IFNG • IL2 • TNFA

Clinical study on the protective mechanism of immune response of recombinant herpes zoster vaccine (CHO cell) based on multi-omics (ChiCTR) - P1 | N=80 | Not yet recruiting | Sponsor: Wuxi Center for Disease Control and Prevention; Beijing Luzhu Biotechnology Co.,Ltd.

New P1 trial • Herpes Zoster • Varicella Zoster • CD40LG • CD8 • IL2

Comparison of the Immunogenicity of the LZ901 Vaccine and HZ/su Vaccine in a Mouse Model. (PubMed, Vaccines (Basel)) - "HZ/su (Shingrix®) was approved by the Food and Drug Administration in 2017 for the prevention of HZ in individuals ≥ 50 years of age and showed very good protection from HZ. Most importantly, LZ901 induced higher levels of cell-mediated immunity (CMI) (which plays a decisive role in the efficacy of zoster vaccines) than HZ/su in BALB/c mice. The numbers of cytokine-producing T cells in LZ901-vaccinated mice were significantly greater than those in v-vaccinated mice, and the proportions of CD4+ and CD8+ T cells producing at least two types of cytokines in LZ901-vaccinated mice were significantly greater than those in HZ/su-vaccinated mice."

Journal • Preclinical • Herpes Zoster • Infectious Disease • Varicella Zoster • CD4 • CD8

A Phase â…¢ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine (clinicaltrials.gov) - P3 | N=4 | Recruiting | Sponsor: Beijing Luzhu Biotechnology Co., Ltd.

New P3 trial • Herpes Zoster • Varicella Zoster