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
參與者完成了生物-疫苗VLA15的初級接種計劃（3劑）。
初級接種計劃完成後，應在約一年後進行一次加強針。
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，輝瑞公司（紐交所：PFE）和Valneva SE (納斯達克: VALN, 歐洲紐交所：VLA) 宣佈，第三期“戶外運動員萊姆病疫苗”（VALOR）試驗的參與者已完成萊姆病候選疫苗VLA15的主要接種系列（三劑）。參與者將在2025年萊姆病季節結束之前被監測是否出現萊姆病病例。
“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試驗主要研究的完成是提供針對萊姆病的安全有效生物-疫苗的目標的關鍵一步，”輝瑞疫苗研究與開發高級副總裁兼疫苗首席研究開發官安娜利莎·安德森博士表示。“與Valneva合作開發的萊姆病疫苗候選者VLA15是目前臨床開發時間線上最爲先進的疫苗，目前正在開展兩項3期試驗。”
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首席醫療官Juan Carlos Jaramillo 萬.D.表示：“我們很高興看到我們的VALOR 3期試驗的進展。萊姆病是美國和歐洲最普遍的蟲媒病之一。它可能導致殘疾並進行長時間的醫療治療。鑑於當前臨床干預方法的療效不佳，需求增長及高強度的醫療需求，需要新型治療方案以幫助預防萊姆病。”
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試驗是輝瑞作爲贊助商在美國、加拿大和歐洲高流行性萊姆病地區的多中心、安慰劑對照、隨機、觀察者盲法試驗。該試驗旨在評估6價OspA基礎的萊姆病生物製品候選者VLA15的療效、安全性、耐受性、免疫原性和批次的一致性。試驗對象爲5歲及以上的試驗參與者，將被隨機分爲兩個試驗組，分別接受VLA15或生理鹽水安慰劑的四次劑量 - 分別在0、2、5-9個月和第三劑後的一年，在下一次萊姆病流行季節高峰前進行補強接種。
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.
根據積極數據，輝瑞計劃在2026年向美國食品和藥物管理局（FDA）遞交生物製品許可申請（BLA），並向歐洲藥品管理局（EMA）遞交上市授權申請（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.
到目前爲止，VLA15在所有劑量和年齡組的所有臨床試驗中都顯示出了良好的安全性2,3。獨立數據安全監控委員會（DSMB）在任何治療組中到目前爲止都沒有發現任何安全問題。第二個3期試驗（C4601012）旨在爲5至17歲兒童的安全數據提供更多證據，該試驗於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.
輝瑞和Valneva於2020年4月簽署了一份合作協議，共同開發VLA15，並於2022年6月更新了該協議條款。
譯文內容由第三人軟體翻譯。