- End-of-trial data show 79.7% efficacy in participants aged 50 years and over during long-term follow-up, six to 11 years after vaccination1
- Vaccine efficacy remained high for each year after vaccination, with 82.0% at year 11 after initial vaccination[i]
- No new safety concerns were identified during the follow-up period1
GSK plc has announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrate that RZV maintains efficacy against shingles for more than a decade in adults over 50. The data presented at the European Congress of Clinical Microbiology and Infectious Diseases (ESCMID) in Barcelona, Spain (27–30 April 2024) is based on the ZOSTER-049 study.1
The results from ZOSTER-049, an extension from two phase III clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include:1
- The primary endpoint focused on cumulative vaccine efficacy (VE) in the period from year six to year 11 after vaccination, with 79.7% VE observed in adults aged ≥50 (95% CI 73.7–84.6)
- VE in adults ≥50 remained high within each individual year after initial vaccination in ZOE-50 and ZOE-70, with VE in the 11th and final year at 82.0% (95% CI 63.0–92.2)
- High VE rates were observed across all age groups over 50 years of age, including the ≥70 group which had a cumulative VE of 73.1% from six to 11 years after vaccination (95% CI 62.9–80.9)
Dr Javier Díez-Domingo, Principal Investigator, FISABIO (Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain) said: “These final data demonstrate continued protection with the Recombinant Zoster Vaccine over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups. Infectious diseases like shingles pose a significant risk to adults due to the natural decline in our immune system, and these data represent a remarkable advancement in our understanding of what can be achieved long-term for effective protection against shingles.”
Dr. Edel Doorley, MICGP, Rowan Family Practice, said: “Preventative medicine is a key part of my medical practice. With this in mind, I regularly recommend the Shingrix vaccine to patients over 50 years of age because of its strong protection against Shingles and Post Herpetic Neuralgia. It’s great to know that the protection lasts more than a decade.”
Philip Dormitzer, Senior Vice President, Head of Vaccines R&D, said: “We are delighted with the conclusions from this trial, demonstrating that the Recombinant Zoster Vaccine can provide long-term protection for adults aged 50 and over against shingles, a disease that can have debilitating impacts and potentially severe complications. These data go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of RZV vaccination for some participants as they aged into their 80s and 90s. With RZV now included in many national immunisation programmes around the world, these data add to the body of evidence on the extended long-term protection against shingles provided by RZV and provide further confidence to inform public immunisation strategies.”
Globally, shingles will affect up to 1 in 3 people in their lifetime.[ii],[iii],[iv],[v] As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.2 A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression,[vi] as well as other chronic conditions such as COPD, diabetes, and asthma.[vii] The risk of shingles complications, such as post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years,2 also increases with age.[viii] PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies.[ix] The World Health Organization estimates that by 2050, the world’s population of people aged 60 years and older will double to 2.1 billion.[x] The ageing of the population will place more people at risk of developing shingles and its complications. Shingles is also associated with significant healthcare and human cost, with 1–4% of cases requiring hospitalisation,[xi] while 57% of people with shingles reported missing work for an average of 9.1 days.[xii]
About ZOSTER-0491
ZOSTER-049 is a phase III open-label, long-term follow-up trial from two pivotal phase III randomised clinical trials (ZOE-50, ZOE-70). The trial evaluated the efficacy, safety, and immunogenicity in adults 50 years and over at time of vaccination, for six additional years after completion of the ZOE-50 and ZOE-70 trials, up to approximately 11 years of follow-up.
ZOSTER-049 included over 7,000 participants from 18 countries across five continents, with vaccine recipients compared to historical controls.
No new safety concerns were identified during the follow-up period in ZOSTER-049. No serious adverse events were considered causally related to RZV vaccination by the investigators. In adults aged 50 years and over, the most frequently reported adverse reactions with RZV are pain at the injection site, myalgia, fatigue and headache. Most of these reactions were mild to moderate in intensity and generally lasted less than three days.[xiii]
About shingles
Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.2 By age 50, VZV is present in most adults,[xiv]and may reactivate with advancing age.[xv] As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.2
Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.15 The pain is often described as aching, burning, stabbing or shock-like.2 Following the rash, a person can also experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years.2 PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies.9
About Shingrix
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.[xvi],[xvii] RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, RZV is also approved for adults aged 18 years or over at increased risk for shingles. The use of RZV should be in accordance with official recommendations and local product label.
Please refer to the Product Information (PI) for important dosage, administration, and safety information in Europe available at this link: https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
Adverse events associated with Shingrix should be reported to the HPRA (www.hpra.ie) and to GSK at 1800-244-255.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com
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