Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases
Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases
Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, 'Vaccine Against Lyme for Outdoor Recreationists' (VALOR).
聖埃爾布蘭（法國），2024年6月3日——專業疫苗公司Valneva SE（納斯達克股票代碼：VALN；巴黎泛歐交易所：VLA）今天宣佈，萊姆病候選疫苗 VLA15 的兩項2期臨床試驗結果已發表在同行評審的醫學雜誌《柳葉刀傳染病》上。這些試驗，以及針對兒科參與者的第三項2期試驗，支持了當前關鍵的3期試驗 “戶外休閒人員萊姆疫苗”（VALOR）的設計。
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, "We are pleased that these results are now fully available to the broader infectious disease community. Lyme disease is the most prevalent vector-borne infectious disease in North America and Europe, and we are excited about the ongoing trials and progress towards potentially offering a vaccine against this unmet medical need."
瓦爾內瓦首席醫學官胡安·卡洛斯·哈拉米洛醫學博士說：“我們很高興這些結果現已完全可供更廣泛的傳染病界獲得。萊姆病是北美和歐洲最普遍的媒介傳播傳染病，我們對正在進行的試驗以及在可能提供針對這種未滿足的醫療需求的疫苗方面取得的進展感到興奮。”
The article, titled "Optimization of Dose Level and Vaccination Schedule for the VLA15 Lyme Borreliosis Vaccine Candidate Among Healthy Adults: Two Randomized, Phase 2 Studies" provides a detailed analysis of the VLA15-201 and VLA15-202 trial results, which investigated different dose levels and vaccination schedules of VLA15, a hexavalent Lyme disease vaccine candidate targeting most prevalent Borrelia species (serotype 1-6) in North America and Europe.
這篇題爲 “優化健康成年人中 VLA15 萊姆伯氏疏螺旋體病候選疫苗的劑量水平和疫苗接種時間表：兩項隨機 2 期研究” 的文章詳細分析了 VLA15-201 和 VLA15-202 試驗結果，研究了針對北美和歐洲最流行的疏螺旋體物種（血清型 1-6）的六價萊姆病候選疫苗 VLA15 的不同劑量水平和疫苗接種時間表。
VLA15 was shown to be immunogenic across all dose groups and vaccination schedules tested. Strongest antibody responses across all six serotypes were exhibited at the highest dose (180 μg) and broader vaccination intervals (Month 0,2,6). VLA15 has shown a favorable safety and tolerability profile across all trials to date. No safety concerns were observed by an independent Data Safety Monitoring Board (DSMB)1,2, in any treatment group.
經測試，VLA15 在所有劑量組和疫苗接種計劃中均具有免疫原性。在最高劑量（180 μg）和更長的疫苗接種間隔（0,2,6個月）下，所有六種血清型的抗體反應最強。迄今爲止，VLA15 在所有試驗中都顯示出良好的安全性和耐受性。獨立的數據安全監測委員會（DSMB）1,2在任何治療組中均未觀察到任何安全問題。
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 20223. The companies previously reported positive results for the booster phase of trial VLA15-2024 and a third Phase 2 trial, VLA15-2215, providing further evidence on VLA15's safety profile and its potential to provide immunity against Lyme disease in adult, pediatric and adolescent populations. The companies also aim to publish these results in a peer-reviewed medical journal.
Valneva 和 Pfizer 於 2020 年 4 月簽訂了合作協議，共同開發 VLA15，並於 2023 年 6 月對該協議中的條款進行了更新。兩家公司此前報告了 VLA15-2024 試驗的加強階段和第三項 2 期試驗 VLA15-2215 的積極結果，這進一步證實了 VLA15 的安全性及其爲成人、兒童和青少年群體提供萊姆病免疫的潛力。兩家公司的目標還是在同行評審的醫學期刊上發表這些結果。
The Phase 3 clinical trial, VALOR, is currently ongoing to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States, Canada and Europe. Enrollment of 9,437 participants for the trial was completed in December 2023.
名爲 VALOR 的 3 期臨床試驗目前正在進行中，旨在研究 VLA15 對美國、加拿大和歐洲高度流行地區的五歲及以上參與者的療效、安全性和免疫原性。該試驗的9,437名參與者的註冊於2023年12月完成。
Subject to positive data, Pfizer aims to submit a Biologic License Application to the Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026.
根據積極的數據，輝瑞的目標是在2026年向食品藥品監督管理局提交生物許可申請，並向歐洲藥品管理局提交上市許可申請。
About VLA15
There are currently no approved human vaccines for Lyme disease, and VLA15 has advanced the furthest of any Lyme vaccine candidates currently in clinical development, with two Phase 3 trials in progress. This 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. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium's ability to leave the tick and infect humans. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe.
關於 VLA15
目前尚無獲批准的萊姆病人用疫苗，在目前處於臨床開發的所有萊姆病候選疫苗中，VLA15 的進展最快，兩項 3 期試驗正在進行中。這種正在研究的多價蛋白亞單位疫苗使用萊姆病疫苗的既定作用機制，該疫苗靶向引起萊姆病的細菌伯氏疏螺旋體外表面蛋白A（oSpA）。oSpA 是細菌在蜱中存在時表達的一種表面蛋白。阻斷 oSpA 會抑制細菌離開壁蝨並感染人類的能力。該候選疫苗涵蓋了北美和歐洲伯氏疏螺旋體所表達的六種最常見的OspA血清型。
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of infected Ixodes ticks6. It is the most common vector-borne illness in the Northern Hemisphere7,8. While the true incidence of Lyme disease is unknown, the Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 129,000 cases are reported annually in Europe9,10. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system9,10. The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens11.
關於萊姆病
萊姆病是一種全身性感染，由伯氏疏螺旋體細菌通過被感染的Ixodes ticks6的叮咬傳播給人類。它是北半球最常見的病媒傳播疾病7,8。儘管萊姆病的真實發病率尚不清楚，但美國疾病控制與預防中心（CDC）估計，美國每年約有47.6萬人接受診斷和治療，歐洲每年報告12.9萬例病例9,10。萊姆病的早期症狀（例如逐漸擴大的稱爲偏頭紅斑的紅斑皮疹或其他非特異性症狀，例如疲勞、發燒、頭痛、輕度頸部僵硬、肌肉和關節疼痛）經常被忽視或誤解。如果不加以治療，這種疾病可能會傳播並導致更嚴重的慢性併發症，影響皮膚、關節（關節炎）、心臟（心臟炎）或神經系統9,10。隨着萊姆病地理足跡的擴大，對萊姆病疫苗接種的醫療需求穩步增加11。
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.
關於 Valneva SE
我們是一家專業疫苗公司，開發、製造和商業化傳染病預防性疫苗，以滿足未滿足的醫療需求。我們採取高度專業化和有針對性的方法，將我們的深厚專業知識應用於多種疫苗模式，專注於提供一流、最佳或唯一的疫苗解決方案。
我們有良好的往績記錄，從早期研發到批准，已將多種疫苗推進到批准，目前利用我們已建立的商業基礎設施銷售三種專有旅行疫苗以及某些第三方疫苗。
我們不斷增長的商業業務的收入有助於推動我們疫苗管道的持續發展。這包括與輝瑞合作開發的唯一萊姆病候選疫苗，以及針對寨卡病毒和其他全球公共衛生威脅的候選疫苗。
1 Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate - Valneva
2 Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate - Valneva
3 Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15 - Valneva
4 Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate - Valneva
5 Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate - Valneva
6 Stanek, et al. Lyme Borreliosis. 2012. The Lancet 379:461–473.
7 Burn L, et al. Incidence of Lyme Borreliosis in Europe from National Surveillance Systems (2005–2020). 2023. Vector Borne and Zoonotic Diseases. 23(4):156–171.
8 Kugeler KJ, et al. Estimating the frequency of Lyme disease diagnoses—United States, 2010-2018. 2021. Emergency Infectious Disease. 27(2).
9 Centers for Disease Control and Prevention. Lyme disease. Signs and Symptoms. Available from: Accessed September 2022.
10 Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature Reviews Disease Primers. 2016;2:16090.
11 Centers for Disease Control and Prevention. Understanding Lyme and Other Tickborne Diseases. May 2022. Available from: . Accessed April 2024.
1 Valneva和輝瑞報告了萊姆病候選疫苗的2期兒科陽性數據-Valneva
2 Valneva和輝瑞報告了萊姆病候選疫苗的兒童和成人的六個月抗體持久性數據-Valneva
3 Valneva和輝瑞簽訂了萊姆病候選疫苗 VLA15 的股權認購協議並更新了合作條款協議-Valneva
4 Valneva和輝瑞報告了萊姆病候選疫苗Valneva的更多陽性2期結果，包括加強反應
5 Valneva和輝瑞報告了萊姆病候選疫苗Valneva的兒童和青少年2期加強劑的陽性結果
6 Stanek 等人。萊姆伯氏疏螺旋體病。2012。《柳葉刀》379:461 —473。
7 Burn L 等人。來自國家監測系統的歐洲萊姆伯氏疏螺旋體病發病率（2005—2020 年）。2023。媒介傳播和人畜共患疾病。23 (4): 156—171。
8 Kugeler KJ 等人估計萊姆病的診斷頻率——美國，2010-2018年。2021年。緊急傳染病。27 (2)。
9 疾病控制和預防中心。萊姆病。體徵和症狀。可用時間：2022年9月訪問。
10 Steere AC、Strle F、Wormser GP 等萊姆伯氏疏螺旋體病。《自然評論》疾病入門。2016；2:16090。
11 疾病控制和預防中心。了解萊姆病和其他蜱傳疾病。2022年5月。可從:.2024 年 4 月訪問。
譯文內容由第三人軟體翻譯。