The recombinant zoster vaccine demonstrated a 79.7% efficacy in patients aged 50 years and older cumulatively within the 6- to 11-year period after vaccination.
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Trial Name: A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
ClinicalTrials.gov ID: NCT02723773
Sponsor: GlaxoSmithKline
Completion Date: June 28, 2023
Positive data from the phase 3 trial ZOSTER-049 (NCT02723773) demonstrated that the recombinant zoster vaccine (RZV, Shingrix; GlaxoSmithKline) maintained efficacy against shingles for more than a decade in adult patients over the age of 50 years. The trial is a long-term, follow-up trial that followed the enrolled patients for approximately 11 years after initial vaccination.1
RZV is a non-live, recombinant subunit vaccine that is indicated for the prevention of shingles in adults who are 50 years of age and older. The vaccine combines glycoprotein E, an antigen, with AS01B, an adjuvant system, that potentially helps patients overcome the natural age-related decline responses to immunization which contributes to the protection this population has against shingles. RZV is also indicated for patients aged 18 years and older who are at an increased risk for shingles, and it is not indicated to prevent primary varicella infection, also called chickenpox.1
The ZOSTER-049 trial, also called ZOE-LTFU, is a long-term follow-up phase 3 trial that comes after the 2 randomized phase 3 trials, ZOSTER-006 and ZOSTER-022 (also called ZOE-50 and ZOE-70, respectively). Over 7541 participants aged 50 and older from the prior phase 3 trials were enrolled in the current trial. The safety, efficacy, and immunogenicity of the RZV vaccine were evaluated at the time of vaccination and for 6 additional years after patients completed the ZOSTER-006 and ZOSTER-022 trial, and were observed for up to 11 years.1,2
According to the trial results, RZV demonstrated a 79.7% vaccine efficacy (VE) in patients aged 50 years and older cumulatively within the 6- to 11-year period after vaccination (95% CI 73.7–84.6). Adults aged 70 years and older showed positive results as well, with a 73.1% VE observed cumulatively within the 6- to 11-year period after vaccination (95% CI 62.9–80.9), indicating that VE is high across both age groups. Further, at year 11, an 82% VE was observed in adults (95% CI 63.0–92.2), with VE remaining high each year following initial vaccination.1
“These final data demonstrate continued protection over more than a decade with high efficacy maintained in both the 50 plus and 70 plus 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,” said Javier Díez-Domingo, PhD, principal investigator, Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain, in a press release.1
According to the investigators, there were no new safety concerns identified during the trial. Further, no serious adverse events (AEs) were considered to be related to the RZV vaccination. The most common AEs reported by the patients who received the RZV vaccine were pain at the injection site, myalgia, fatigue, and headache; however, most of these occurrences were mild to moderate in intensity and lasted less than 3 days. The study data will be presented at the European Society of Clinical Microbiology and Infectious Diseases Global in Barcelona, Spain, from April 27, 2024, to April 30, 2024.1
“These data go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of vaccination for some participants as they aged into their 70s, 80s, and 90s,” said Phil Dormitzer, senior vice president, Head of Vaccines R&D, in the press release. "With the vaccine now included in many national immunization programs around the world, these data add to the body of evidence on the extended long-term protection against shingles and provide further confidence to inform public immunization strategies."1
