The results of the final trial showed that Shingrix is effective against shingles with high vaccine efficacy rate for almost ten years in adults aged 50 years and over
GSK reports new long-term data of Shingrix against shingles in adults aged 50 and over. (Credit: GSK plc)
GSK said that its Shingrix (Recombinant Zoster Vaccine or RZV) has provided high protection against shingles for over a decade in the ZOSTER-049 Phase 3 trial.
The long-term follow-up trial followed adults aged 50 years and over for up to approximately 11 years following initial vaccination with Shingrix.
ZOSTER-049 is an extension from the ZOE-50 and ZOE-70 randomised Phase 3 clinical trials in adults aged 50 and over.
The open-label study evaluated the efficacy, safety, and immunogenicity of the vaccine in over 7,000 participants for six additional years after conclusion of the ZOE-50 and ZOE-70.
The results of the final trial showed that RZV is effective against shingles for almost ten years in these patients.
It demonstrated 79.7% vaccine efficacy (VE) cumulatively within the period from six years six to 11 years post-vaccination.
For the period after year 11, 82% VE was found in adults ≥50, demonstrating that VE remains high in each year after vaccination.
Additionally, 73.1% VE in adults aged 70 or more cumulatively from six to 11 years after vaccination. This showed high VE rates across all age groups.
GSK senior vice president and vaccines R&D head Phil Dormitzer said: “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.
“With the vaccine 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 and provide further confidence to inform public immunisation strategies.”
GSK said that it will continue evaluating long-term data and conduct real-world evidence trials linked to the efficacy, immunogenicity, and safety of the shingles vaccine across indicated populations.
In a separate development, the British drug maker announced results from the EAGLE-1 Phase 3 trial of gepotidacin, an oral antibiotic for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults.
The drug candidate recorded a 92.6% microbiological success rate and was non-inferior in comparison to the leading combination treatment regimen for gonorrhoea.
GSK is also working on gepotidacin to treat uncomplicated urinary tract infections (uUTI).