GSK's Recombinant Zoster Vaccine Shingrix Demonstrates 100% Efficacy in Chinese Adults Aged 50 and Older in Phase IV ZOSTER-076 Trial

GSK recently announced positive results from the first efficacy study in China for Shingrix (recombinant zoster vaccine). These results come from the post-marketing Phase IV clinical trial (ZOSTER-076), which evaluated the efficacy and safety of the recombinant zoster vaccine in preventing shingles in adults aged 50 years and older. The study enrolled approximately 6,000 participants, who were randomly assigned in a 1:1 ratio to either the recombinant zoster vaccine group or the placebo group in an observer-blind trial. No cases of shingles were reported in the recombinant zoster vaccine group, compared to 31 cases in the placebo group.
Latest Results Consistent with Previous Pivotal Phase III Clinical Trials (ZOE-50 and ZOE-70) of Recombinant Zoster VaccineThe latest results are consistent with the findings from two previous pivotal Phase III clinical trials (ZOE-50 and ZOE-70) of the recombinant zoster vaccine. The trial results indicate that during approximately four years of follow-up post-vaccination, Shingrix demonstrated 97% efficacy in preventing shingles in adults aged 50 years and older. The safety profile observed in this trial is consistent with the vaccine’s established safety characteristics. The new research data effectively supplements existing evidence, further confirming the efficacy and safety profile of the recombinant zoster vaccine in adults aged 50 years and above.
Globally, over 90% of adults harbor the varicella-zoster virus (VZV), which often remains latent in the nervous system. As people age, the virus may reactivate, leading to shingles. The population of individuals aged 65 and above in China is rapidly increasing, with their proportion of the total population expected to rise from 6.8% in 2000 to 23.6% by 2050. It is estimated that there are approximately 6 million shingles cases annually in China, and this number is expected to grow further due to the accelerating aging population.
In 2019, the recombinant zoster vaccine was approved for the first time in China to prevent shingles in adults aged 50 years and older. This post-marketing trial aims to meet regulatory requirements by evaluating the efficacy and safety of two doses of the recombinant zoster vaccine in Chinese adults. The trial further confirmed the efficacy of the recombinant zoster vaccine in preventing shingles in adults aged 50 years and older, regardless of gender, region, or ancestry/ethnicity.
Data from this Phase IV clinical trial will be submitted to a peer-reviewed medical journal and published publicly in the second half of this year.

About the ZOSTER-076 Clinical Trial
ZOSTER-076 is a Phase IV, randomized, observer-blind, placebo-controlled multicenter trial designed to evaluate the efficacy of the recombinant zoster vaccine in preventing herpes zoster (HZ) in adults aged 50 years and above in China, as well as the immunogenicity and safety of the vaccine. Subjects receive two doses of the recombinant zoster vaccine.
This clinical trial was conducted between 2021 and 2023, enrolling approximately 6,000 adults (adjusted exposure set n= 5956). The vaccine efficacy was 100% (95% CI: 89.82%-100.00%), with the incidence of HZ being 0/1,000 person-years in the recombinant zoster vaccine group and 8.2/1,000 person-years in the placebo group (p<0.0001)1. The safety observed in this trial was consistent with the vaccine’s previous safety profile.