Benzinga - by Vandana Singh, Benzinga Editor.
Wednesday, GSK plc (NYSE:GSK) revealed data from the ZOSTER-049 long-term follow-up phase 3 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 has maintained efficacy against shingles in adults over 50 for over a decade.
ZOSTER-049 included over 7,000 participants.
The results from ZOSTER-049, an extension from two phase 3 clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include:
- 79.7% vaccine efficacy (VE) in adults aged ≥50 cumulatively from year six to year 11 after vaccination.
- 82.0% VE in adults ≥50 at year 11, showing VE remains high each year after vaccination.
- 73.1% VE in adults aged ≥70 cumulatively from six to 11 years after vaccination, showing high VE rates across all age groups.
GSK said it will continue to evaluate long-term data and conduct real-world evidence studies on vaccine efficacy, immunogenicity, and safety across indicated populations.
No new safety concerns were identified during the follow-up period in ZOSTER-049.
The investigators considered no serious adverse events causally related to RZV vaccination.
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.
Wednesday, GSK also announced results from the pivotal EAGLE-1 Phase 3 trial for gepotidacin, an oral antibiotic for uncomplicated urogenital gonorrhea in adolescents and adults.
The results from EAGLE-1 are based on a primary endpoint of microbiological response (success or failure of eliminating the bacterial cause of gonorrhea) at the Test-of-Cure (ToC) visit 3-7 days after treatment.
The trial showed that gepotidacin (oral, two doses of 3,000mg) was non-inferior, with 92.6% success rates, compared to 91.2% success rates for intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhea.
GSK is also developing gepotidacin for uncomplicated urinary tract infection.
Price Action: GSK shares are down 1.15% at $39.49 during the premarket session on the last check Wednesday.
Photo via Wikimedia Commons
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