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GSK plc announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076), which evaluated the efficacy and safety of RZV in preventing shingles in adults aged 50 and over. The trial included almost 6,000 participants randomised 1:1 to the RZV or placebo group and followed in an observer-blind design. No cases of shingles were reported among the participants who received RZV, compared to 31 cases in the placebo arm.
The results are in line with findings from the pivotal phase III trials ZOE-50 and ZOE-70 investigating the efficacy and safety of RZV, showing vaccine efficacy was up to 97%2 in adults aged 50 and over, over a follow-up period of approximately four years. The safety profile observed in this trial was consistent with the established safety profile of the vaccine. The new data add to the growing body of evidence affirming the efficacy and safety profile of RZV in preventing shingles in adults aged 50 and over.
Globally, the varicella zoster virus (VZV) is present in over 90% of adults. VZV remains dormant in the nervous system, waiting to reactivate as shingles with advancing age. The population of people aged 65 and over in China is rapidly increasing, with a predicted percentage increase from 6.8% in 2000 to 23.6% by 2050. It is estimated that there are approximately 6 million cases of shingles in China each year, and this number is expected to increase in line with local population ageing.
RZV was first licensed for use in China in 2019 for the prevention of herpes zoster in adults aged 50 and over. This post-licence trial was undertaken to fulfil the requirement of regulatory authorities to evaluate the vaccine efficacy and safety of two doses of RZV for the prevention of shingles in China. The trial further demonstrates RZV’s efficacy in preventing herpes zoster in adults aged 50 and over irrespective of sex, geographic region and ancestry/ethnicity.
Results from this phase IV trial will be submitted for publication in a peer-reviewed scientific journal later this year.
ZOSTER-076 was a phase IV, randomised, observer-blind, placebo-controlled, multi-centre trial to assess the prophylactic efficacy against herpes zoster (HZ) and the immunogenicity and safety of RZV when administered intramuscularly on a 2-dose schedule in adults aged 50 and over in China.
The trial was conducted between 2021 and 2023. It included almost 6,000 adults (n=5,956). Vaccine efficacy was 100% (95% CI: 89.82%-100%). HZ incidence rate of 0/1,000 person years in the RZV arm versus an incidence rate of 8.2/1,000 person years in the placebo arm, p<0.0001. The safety profile observed in this trial was consistent with the established safety profile of the vaccine.
Shingles, also known as herpes zoster, is caused by a reactivation of the varicella-zoster virus (VZV) – the same virus that causes chickenpox. Globally, most people aged 50 and over have the dormant VZV in their nervous system and are at risk of developing shingles. As people age, the strength of the immune system wanes, leading to a decreased response to infection and thus increasing the risk of developing shingles. People with a suppressed or compromised immune system are also at risk of shingles.
Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience postherpetic neuralgia (PHN), a long-lasting nerve pain that can continue for weeks or months and in some cases can persists for several years. PHN is the most common complication of shingles, occurring in 5-30% of all shingles cases depending on the individual’s age.
Shingrix (Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles. RZV is not indicated to prevent primary varicella infection (chickenpox). In some countries, RZV is also approved for adults aged 18 years or over who are at increased risk for shingles.
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