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 VLA15 的初級疫苗接種系列（3 劑）
初級疫苗接種系列將在完成大約一年後進行加強接種
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.
紐約州紐約和聖埃爾布蘭（法國），2024年7月17日——輝瑞公司（紐約證券交易所代碼：PFE）和瓦爾內瓦證券交易所（納斯達克股票代碼：VALN；巴黎泛歐交易所：VLA）今天宣佈，“戶外休閒者萊姆疫苗”（VALOR）3期試驗的參與者已經完成了萊姆病候選疫苗 VLA15 的初級疫苗系列（三劑）。在2025年萊姆病季節結束之前，將對參與者的萊姆病病例發病率進行監測。
“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.”
輝瑞高級副總裁兼疫苗研發負責人安娜麗莎·安德森博士說：“我們的VALOR試驗主要系列的完成是朝着提供安全有效的萊姆病疫苗的目標邁出的關鍵一步。”“我們正在與Valneva共同開發的萊姆病候選疫苗 VLA15 是臨床開發時間表上進展最快的疫苗，兩項3期試驗正在進行中。”
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.”
瓦爾內瓦首席醫學官胡安·卡洛斯·賈拉米洛萬博士說：“我們很高興看到我們的3期VALOR試驗取得進展。萊姆病是美國和歐洲最常見的病媒傳播疾病。它可能導致使人衰弱的併發症和廣泛的醫療保健治療。鑑於負擔不斷增加、醫療需求高企以及當前干預措施缺乏有效性，迫切需要新的方法來幫助預防萊姆病。”
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.
輝瑞是贊助商的VALOR試驗是一項多中心、安慰劑對照、隨機、觀察者盲試驗，在美國、加拿大和歐洲萊姆病高度流行地區的試驗點進行。該試驗的目的是評估 VLA15（一種基於 OSPA 的 6 價萊姆病候選疫苗）的療效、安全性、耐受性、免疫原性和批次一致性。1 5 歲及以上的試驗參與者以 1:1 的比例隨機分爲兩個試驗組，接受四劑 VLA15 或生理鹽安慰劑——在第 0、2、5-9 個月各接種一劑，在第三劑高峰期前不久的第三劑後一年下一個萊姆病季節。
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.
根據積極的數據，輝瑞計劃於2026年向美國食品藥品監督管理局（FDA）提交生物製劑許可申請（BLA），向歐洲藥品管理局（EMA）提交上市許可申請（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.
在迄今爲止的所有臨床試驗中，VLA15 在所有劑量和年齡組中均顯示出良好的安全性2,3。迄今爲止，獨立的數據安全監測委員會（DSMB）尚未在任何治療組中觀察到任何安全問題。第二項三期試驗（C4601012）正在進行中，旨在進一步證實 VLA15 在 5 至 17 歲兒童人群中的安全性；該試驗於 2023 年 6 月完成入組。
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 月簽訂了合作協議，共同開發 VLA15，並於 2022 年 6 月對該協議中的條款進行了更新。