Drug makers Pfizer Inc. (PFE) and Valneva SE (VALN) announced Tuesday positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.Pfizer aims to submit a Biologics License Application or BLA to the U.S.

制药商辉瑞公司（Pfizer Inc.）和Valneva SE（VALN）周二宣布，他们的VLA15-221 2期研究的免疫原性和安全性数据呈阳性，此前他们的莱姆病候选疫苗VLA15在接受第一次加强剂量一年后进行了第二次加强接种。辉瑞计划向美国提交生物制品许可证申请或BLA。

Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.In a statement, the companies noted that the immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose.

2026年，美国食品和药物管理局（FDA）向欧洲药品管理局（European Medicines Agency）提交了上市许可申请，但第三阶段数据为阳性。在一份声明中，这些公司指出，接受第二次加强剂量后一个月，VLA15的免疫反应和安全性与接受第一次加强剂量后报告的相似。

It showed compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season.Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of infected Ixodes ticks. If left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints, heart or nervous system.

莱姆病是由伯氏疏螺旋体细菌引起的全身感染，通过受感染的硬蜱叮咬传播给人类。如果不及时治疗，这种疾病可能会传播，并导致更严重的慢性并发症，影响皮肤、关节、心脏或神经系统。

There are currently no approved human vaccines for Lyme disease.Around 476,000 people are diagnosed and treated for Lyme disease each year in the U.S., according to the Centers for Disease Control and Prevention, while around 129,000 cases are reported annually in Europe.VLA15, an investigational multivalent protein subunit vaccine, uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease..

目前还没有批准用于莱姆病的人类疫苗。根据疾病控制和预防中心的数据，美国每年约有476000人被诊断和治疗莱姆病，而欧洲每年报告约129000例。VLA15是一种研究性多价蛋白亚单位疫苗，它使用莱姆病疫苗的既定作用机制，该疫苗针对伯氏疏螺旋体的外表面蛋白a（OspA），伯氏疏螺旋体是引起莱姆病的细菌。。

The companies noted that VLA15, the Lyme disease vaccine candidate, has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.In August 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the U.S.

这些公司指出，莱姆病候选疫苗VLA15在临床开发时间表上进展最快，正在进行两项3期试验。2022年8月，辉瑞（Pfizer）和瓦尔内瓦（Valneva）启动了目前正在进行的第三阶段临床研究，即户外休闲者莱姆病疫苗（VALOR）（NCT05477524），以调查VLA15在美国高度流行地区五岁及以上参与者中的疗效，安全性和免疫原性。

and Europe.The companies noted that favorable safety profile of VLA15 was observed in all age groups and for all vaccinations.The primary vaccination series for all participants was completed in July 2024. A second Phase 3 study (VLA15-1012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also ongoing.For More Such Health News, visit rttnews.com For comments and feedback contact: editorial@rttnews.com.

和欧洲。。所有参与者的主要疫苗接种系列于2024年7月完成。第二项3期研究（VLA15-1012）也正在进行中，旨在为VLA15在儿科人群中的安全性提供进一步的证据。有关更多此类健康新闻，请访问rttnews.com获取评论和反馈联系方式：editorial@rttnews.com.