CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation MRNA Vaccine Booster
CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation MRNA Vaccine Booster
Study conducted by Meiji Seika Pharma in Japan
明治製藥在日本進行的研究
Data follow approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine for Adults by Japan Ministry of Health, Labor and Welfare
The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan, was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with Comirnaty
Phase 3 Study published in The Lancet Infectious Diseases
數據是在日本厚生勞動省批准世界上第一款成人自擴增信使 RNA (sa-mRNA) COVID-19 疫苗之後得出的
這項在日本 11 個地點進行的隨機、雙盲、主動對照研究旨在比較 sa-mRNA 疫苗 ARCT-154 與 Comirnaty 的免疫原性和耐受性
發表在《柳葉刀傳染病》上的3期研究
KING OF PRUSSIA, Pa. & SAN DIEGO--(BUSINESS WIRE)--Dec. 21, 2023-- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty. ARCT-154 results were achieved with one sixth the dose of Comirnaty (5 μg vs 30 μg).
賓夕法尼亞州普魯士國王和聖地亞哥--(美國商業資訊)--2023年12月21日--全球生物技術領導者CSL（澳大利亞證券交易所股票代碼：CSL；USOTC: CSLLY）和Arcturus Therapeutics（納斯達克股票代碼：ARCT）今天宣佈在《柳葉刀傳染病》上發表一項三期研究，該研究表明，一種新型的自擴增信使 RNA (sa-mRNA) 疫苗 ARCT-154 的加強劑量引發了一種與原始武漢-Hu-1病毒株相比，對SARS-Hu-1病毒株的免疫反應更高（符合非劣勢標準），對SARS-CoV-2病毒的Omicron BA.4/5亞變體的免疫反應更好傳統 mRNA 疫苗 Comirnaty 的加強劑量。ARCT-154 的結果是使用 Comirnaty 劑量的六分之一（5 μg 對 30 μg）獲得的。
The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty or Spikevax); and then a third dose of Comirnaty at least three months prior to the booster dose of either ARCT-154 or Comirnaty in the study. Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
該研究包括最初接種兩劑mRNA疫苗（Comirnaty或Spikevax）的健康成年人；然後在研究中 ARCT-154 或Comirnaty加強劑量前至少三個月接種第三劑Comirnaty。兩種疫苗的耐受性良好，沒有因果相關的嚴重或嚴重不良事件。該研究是與總部位於日本的全球健康公司明治製藥合作進行的。
"The initial head-to-head results of the ARCT-154 study are exciting as they show that our sa-mRNA vaccine platform has the potential to produce immunogenicity against COVID-19 in previously vaccinated patients that is as good or better—and at a much lower dose—than first generation mRNA vaccines," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. "These results move CSL one step closer to delivering on our promise to develop and provide differentiated innovations that help protect the public against the ongoing burden of COVID-19. We look forward to sharing additional data from CSL's sa-mRNA programs as we continue to advance this exciting technology."
CSL 疫苗創新部高級副總裁喬納森·愛德曼醫學博士說：“ARCT-154 研究的初步正面交鋒結果令人興奮，因爲它們表明我們的 sa-mRNA 疫苗平台有可能在先前接種過疫苗的患者中產生針對 COVID-19 的免疫原性，這種免疫原性與第一代 mRNA 疫苗一樣好或更好，而且劑量要低得多。”“這些結果使CSL離兌現我們的承諾又近了一步，即開發和提供差異化創新，幫助保護公衆免受 COVID-19 的持續負擔。隨着我們繼續推進這項令人興奮的技術，我們期待分享來自CSL的SA-mRNA計劃的更多數據。”
"These important study findings mark another major achievement in the development of our innovative sa-mRNA vaccine platform and a significant moment for Arcturus and CSL," said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics. "This study represents the first phase of CSL and Arcturus' plans to launch this innovative vaccine platform globally."
Arcturus Therapeutics首席科學官帕德·奇武庫拉博士說：“這些重要的研究發現標誌着我們在開發創新的sa-mRNA疫苗平台方面取得了又一項重大成就，也是Arcturus和CSL的重要時刻。”“這項研究代表了CSL和Arcturus計劃在全球推出這一創新疫苗平台的第一階段。”
The phase 3 study results with ARCT-154 were used to support the approval of ARCT-154 for primary immunization and as a booster dose in Japan in November of this year.
ARCT-154 的 3 期研究結果被用來支持日本於今年 11 月批准 ARCT-154 用於初級免疫和作爲加強劑量。
The ARCT-154 study is ongoing and will continue to collect safety data and assess durability of the immune response in participants at 3-, 6- and 12-months post-vaccination.
ARCT-154 研究正在進行中，並將繼續收集安全數據並評估參與者在疫苗接種後 3、6 和 12 個月內免疫反應的耐久性。
譯文內容由第三人軟體翻譯。