Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion
Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion
July 17, 2024
2024年7月17日
Participants completed primary vaccination series (3 doses) with VLA15
Primary vaccination series to be followed by a booster approximately one year after completion
参与者完成了生物-疫苗VLA15的初级接种计划(3剂)。
初级接种计划完成后,应在约一年后进行一次加强针。
New York, NY and Saint-Herblain (France), July 17, 2024 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the participants of the Phase 3 trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.
2024年7月17日,纽约和圣埃尔布兰(法国)-辉瑞(Pfizer Inc.)(纽交所:PFE)和万福沙公司(Valneva SE)(纳斯达克:VALN;欧洲泛欧洲交易所:VLA)今天宣布,莱姆病疫苗候选品VLA15的第3期试验“面向户外运动爱好者的莱姆病疫苗”(VALOR)的参与者已完成基础疫苗接种程序(三剂)。参与者将被监测至莱姆病季节结束,直至2025年。
“The completion of the primary series of our VALOR trial is a critical step toward our goal of providing a safe and effective vaccine against Lyme disease,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer. “VLA15, the Lyme disease vaccine candidate we are co-developing with Valneva, is the one which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.”
“VALOR试验主要研究的完成是提供针对莱姆病的安全有效生物-疫苗的目标的关键一步,”辉瑞疫苗研究与开发高级副总裁兼疫苗首席研究开发官安娜利莎·安德森博士表示。“与Valneva合作开发的莱姆病疫苗候选者VLA15是目前临床开发时间线上最为先进的疫苗,目前正在开展两项3期试验。”
Juan Carlos Jaramillo, M.D., Chief Medical Officer, Valneva, said, “We are pleased to see the progress of our Phase 3 VALOR trial. Lyme disease is the most prevalent vector-borne disease in the United States and Europe. It can result in debilitating complications and extensive healthcare treatments. Given the growing burden, high medical need, and lack of effectiveness with current interventions, there is an urgent need for novel approaches to help prevent Lyme disease.”
Valneva首席医疗官Juan Carlos Jaramillo 万.D.表示:“我们很高兴看到我们的VALOR 3期试验的进展。莱姆病是美国和欧洲最普遍的虫媒病之一。它可能导致残疾并进行长时间的医疗治疗。鉴于当前临床干预方法的疗效不佳,需求增长及高强度的医疗需求,需要新型治疗方案以帮助预防莱姆病。”
The VALOR trial, for which Pfizer is the sponsor, is a multicenter, placebo-controlled, randomized, observer-blinded trial conducted at sites in areas where Lyme disease is highly endemic across the U.S., Canada, and Europe. The aim of the trial is to evaluate the efficacy, safety, tolerability, immunogenicity, and lot consistency of VLA15, a 6-valent OspA-based Lyme disease vaccine candidate.1 Trial participants aged 5 years and older were randomized 1:1 into two trial groups and receive four doses of either VLA15 or a saline placebo – one dose each at months 0, 2, 5-9 and a booster one year after the third dose, shortly before the peak of the next Lyme disease season.
VALOR试验是辉瑞作为赞助商在美国、加拿大和欧洲高流行性莱姆病地区的多中心、安慰剂对照、随机、观察者盲法试验。该试验旨在评估6价OspA基础的莱姆病生物制品候选者VLA15的疗效、安全性、耐受性、免疫原性和批次的一致性。试验对象为5岁及以上的试验参与者,将被随机分为两个试验组,分别接受VLA15或生理盐水安慰剂的四次剂量 - 分别在0、2、5-9个月和第三剂后的一年,在下一次莱姆病流行季节高峰前进行补强接种。
Subject to positive data, Pfizer plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026.
根据积极数据,辉瑞计划在2026年向美国食品和药物管理局(FDA)递交生物制品许可申请(BLA),并向欧洲药品管理局(EMA)递交上市授权申请(MAA)。
VLA15 has shown a favorable safety profile across all dose and age groups in all clinical trials to date2,3. No safety concerns have been observed to date by an independent Data Safety Monitoring Board (DSMB) in any treatment group. A second Phase 3 trial (C4601012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population between 5 and 17 years of age is ongoing; this trial completed enrollment in June 2023.
到目前为止,VLA15在所有剂量和年龄组的所有临床试验中都显示出了良好的安全性2,3。独立数据安全监控委员会(DSMB)在任何治疗组中到目前为止都没有发现任何安全问题。第二个3期试验(C4601012)旨在为5至17岁儿童的安全数据提供更多证据,该试验于2023年6月完成招募。
Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.
辉瑞和Valneva于2020年4月签署了一份合作协议,共同开发VLA15,并于2022年6月更新了该协议条款。