GSK Says Its Blockbuster Shingles Vaccine Shows High Efficacy Even After 10 Years
GSK Says Its Blockbuster Shingles Vaccine Shows High Efficacy Even After 10 Years
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).
周三，葛兰素史克公司（纽约证券交易所代码：GSK）透露了 ZOSTER-049 长期随访第 3 期试验的数据，该试验在首次接种疫苗后对参与者进行了长达 11 年的跟踪 Shingrix （重组带状疱疹疫苗或 RZV）。
The final trial data demonstrate that RZV has maintained efficacy against shingles in adults over 50 for over a decade.
最终的试验数据表明，十多年来，RZV一直保持对50岁以上成年人带状疱疹的疗效。
ZOSTER-049 included over 7,000 participants.
ZOSTER-049 包括超过 7,000 名参与者。
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:
ZOSTER-049 是两项针对 50 岁及以上成人（ZOE-50 和 ZOE-70）的 3 期临床试验（和）的延伸，其结果包括：
- 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.
- 接种后的六年至十一年级，年龄在≥50岁的成年人中，累计疫苗疗效（VE）为79.7％。
- 在11年级，年龄在50岁以上的成年人中，VE为82.0％，表明疫苗接种后每年VE仍然很高。
- 在接种疫苗后的六至十一年中，年龄在≥70岁的成年人中，VE的累积率为73.1％，显示所有年龄组的VE发生率都很高。
Javier Díez-Domingo, Principal Investigator, said: "These final data demonstrate continued protection over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups."
首席研究员哈维尔·迪埃兹-多明戈说：“这些最终数据表明，在十多年来的持续保护下，50岁以上和70岁以上年龄组均保持了高疗效。”
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.
葛兰素史克表示，它将继续评估长期数据，并对特定人群的疫苗功效、免疫原性和安全性进行现实世界的证据研究。
No new safety concerns were identified during the follow-up period in ZOSTER-049.
在 ZOSTER-049 的随访期间，没有发现任何新的安全问题。
The investigators considered no serious adverse events causally related to RZV vaccination.
研究人员认为没有与RZV疫苗接种相关的严重不良事件。
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.
在50岁及以上的成年人中，最常报告的RZV不良反应是注射部位疼痛、肌痛、疲劳和头痛。这些反应中的大多数强度为轻度至中度，通常持续不到三天。
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.
周三，葛兰素史克还公布了针对gepotidacin的关键性EAGLE-1 3期试验的结果，gepotidacin是一种治疗青少年和成人无并发症泌尿生殖系统淋病的口服抗生素。
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.
EAGLE-1 的结果基于治疗后 3-7 天治疗试验 (ToC) 就诊时的微生物反应（消除淋病细菌原因的成功或失败）的主要终点。
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.
该试验显示，格波替达辛（口服，两剂3,000mg）并不逊色，成功率为92.6％，而肌肉注射头孢曲松（500mg）加口服阿奇霉素（1,000mg）联合疗法（一种领先的淋病联合治疗方案）的成功率为91.2％。
GSK is also developing gepotidacin for uncomplicated urinary tract infection.
葛兰素史克还在开发用于无并发症的尿路感染的格波替达辛。
Price Action: GSK shares are down 1.15% at $39.49 during the premarket session on the last check Wednesday.
价格走势：在周三最后一次支票的盘前交易中，葛兰素史克股价下跌1.15％，至39.49美元。
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