GSK Reveals Chinese Study Data with 100% Efficacy for “Recombinant Shingles Vaccine”
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GSK Reveals Chinese Study Data with 100% Efficacy for “Recombinant Shingles Vaccine”
On August 24th, GlaxoSmithKline (GSK) announced positive results from the first-ever protection efficacy study of Shingrix (a recombinant shingles vaccine) in China.
These findings are derived from the post-marketing Phase IV clinical trial (ZOSTER-076), which assessed the protective efficacy and safety of the recombinant shingles vaccine in adults aged 50 and above to prevent shingles.
The results indicate a vaccine efficacy rate of 100%, with no cases of shingles reported among the recipients of the recombinant shingles vaccine. According to a GSK press release, data from this Phase IV clinical trial will be submitted for peer review in medical journals and publicly disclosed later this year.
Shingles, caused by the reactivation of the varicella-zoster virus (VZV), which also causes chickenpox, lurks in the nervous systems of most adults aged 50 and above worldwide.
As people age, the specific cell-mediated immune response against VZV gradually diminishes, increasing the risk of developing shingles. Individuals with compromised immune systems are also at risk of shingles.
Shingles typically manifests as a painful rash, with blistering eruptions on the chest, abdomen, or face. Post-herpetic neuralgia, a long-lasting nerve pain, can follow shingles and may persist for weeks or even years in some patients.
Shingrix, the recombinant shingles vaccine, is a non-live, recombinant subunit-adjuvanted vaccine. This vaccine combines recombinant glycoprotein E antigens with the AS01B adjuvant system, potentially helping to overcome age-related declines in immune function and protect adults aged 50 and above from the challenges of shingles.
In 2019, GSK’s recombinant shingles vaccine was first approved in China for preventing shingles in adults aged 50 and above. The ZOSTER-076 post-marketing trial aimed to meet regulatory requirements by evaluating the shingles protection efficacy and safety of two doses of the recombinant shingles vaccine in Chinese adults.
ZOSTER-076 was a Phase IV, randomized, observer-blinded, placebo-controlled multicenter trial designed to assess the shingles protection efficacy, immunogenicity, and safety of the recombinant shingles vaccine in Chinese adults aged 50 and above. The trial was conducted from 2021 to 2023 and included approximately 6,000 adults (adjusted exposure set n=5956). The vaccine demonstrated 100% protection efficacy (shingles incidence rate of 0/1000 person-years in the recombinant shingles vaccine group compared to 8.2/1000 person-years in the placebo group). The safety profile observed in the trial was consistent with the vaccine’s prior safety characteristics.
These latest results align with the findings from two pivotal Phase III clinical trials (ZOE-50 and ZOE-70) of the recombinant shingles vaccine. Previous trial results indicated a shingles protection efficacy of 97% in adults aged 50 and above during a four-year follow-up period post-vaccination. The new research data further solidify the existing evidence.
According to the GSK press release, this trial further confirms the shingles protection efficacy of the recombinant shingles vaccine in adults aged 50 and above, regardless of gender, geographic region, or ethnicity.
GSK Reveals Chinese Study Data with 100% Efficacy for “Recombinant Shingles Vaccine”
Reference:
[1] Latest Research Data Shows Shingrix® Provides 100% Protection for Adults Aged 50 and Above in China. Retrieved Aug 24, 2023.
(source:internet, reference only)
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