Global biotechnology leader CSL ( and self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus Therapeutics  announced the results of a head-to-head study demonstrating that self-amplifying (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty for up to one year against Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at one-sixth the dose of the comparator (5 μg vs 30 μg, respectively)..

全球生物技术领导者CSL（和自扩增信使RNA（sa mRNA）先驱Arcturus Therapeutics）宣布了一项头对头研究的结果，表明自扩增（sa mRNA）COVID-19疫苗与传统的mRNA疫苗相比，保持了优异的免疫原性。针对武汉Hu-1，Omicron BA.4-5和某些其他变体的Comirnaty长达一年，并且是对照剂量的六分之一（分别为5μg和30μg）。。

The data, presented as a poster at the OPTIONS XII for the Control of Influenza conference, highlights 12-month follow-up analysis of the Phase III trial conducted in Japan by Meiji Seika Pharma, evaluating a booster dose of ARCT154, showing that the vaccine elicited superior immunogenicity and antibody persistence over Comirnaty for up to 12 months postvaccination, against multiple SARS-CoV-2 strains and in both younger and older adult age groups..

这些数据作为海报在“控制流感的选择十二”会议上发布，重点介绍了明治精嘉制药公司在日本进行的III期临床试验的12个月随访分析，评估了ARCT154的增强剂量，表明该疫苗在接种后12个月内对多种SARS-CoV-2毒株以及年轻人和老年人年龄组产生了优于Comirnaty的免疫原性和抗体持久性。。

'The 12-month results from the ARCT 154 study continue to establish the durability of immune response from this self-amplifying mRNA vaccine and reinforce the ability of this vaccine to provide protection against COVID-19 at lower doses compared to conventional mRNA vaccines,' said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.

CSL疫苗创新部门高级副总裁乔纳森·埃德尔曼（JonathanEdelman）医学博士说：“ARCT 154研究的12个月结果继续证实了这种自扩增mRNA疫苗的免疫反应的持久性，并增强了这种疫苗在较低剂量下比传统mRNA疫苗提供针对新型冠状病毒（COVID-19）的保护的能力。”。

'We are proud to showcase at the 2024 OPTIONS conference with these important data about the first sa-mRNA COVID-19 vaccine now approved in Japan.'.

“我们很自豪能在2024年选项会议上展示这些关于日本目前批准的第一种sa mRNA COVID-19疫苗的重要数据。”。

Additional data presented by CSL and Arcturus finds that the bivalent formula, ARCT 2301, developed on the same platform as ARCT 154, induces superior immunogenicity over conventional bivalent mRNA vaccine Comirnaty that persists against key variants up to six months post-vaccination.

CSL和Arcturus提供的其他数据发现，在与ARCT 154相同的平台上开发的二价配方ARCT 2301比传统的二价mRNA疫苗Comirnaty具有更高的免疫原性，这种疫苗在接种后6个月内仍能抵抗关键变体。

'The recent surge in COVID-19 infections and the emerging new variants illustrate the critical need for vaccines that provide a longer duration of protection compared to conventional mRNA vaccines,' said Igor Smolenov, M.D., Ph.D. Chief Development Officer of Arcturus Therapeutics. 'These compelling new studies reaffirm that these sa-mRNA vaccines have the potential to offer potent protection against COVID-19.'.

Arcturus Therapeutics首席开发官伊戈尔·斯莫列诺夫（IgorSmolenov）医学博士说：“最近新型冠状病毒感染的激增和新出现的变异说明，与传统的mRNA疫苗相比，迫切需要提供更长保护期的疫苗。”这些引人注目的新研究重申，这些sa mRNA疫苗有可能提供针对COVID-19的有效保护。

The COVID-19 vaccine from this sa-mRNA platform targeted against the JN.1 variant is approved in Japan for immunization against COVID-19 in adults 18 years and older and is being sold under the trade name Kostaive.

来自该sa mRNA平台的针对JN.1变体的COVID-19疫苗在日本被批准用于18岁及以上成年人的COVID-19免疫接种，并以商品名Kostaive出售。

ARCT-154 12-month Study Design and Results; The randomized, double-blind, active-controlled Phase III study was conducted at 11 clinical sites in Japan. The study enrolled 828 adults ho had previously been fully immunized with three doses of mRNA vaccine(s). Participants were randomized equally to receive a booster dose of either ARCT 154 or Comirnaty.

ARCT-154 12个月的研究设计和结果；这项随机，双盲，主动对照的III期研究在日本的11个临床地点进行。该研究招募了828名成年人，他们之前已经用三剂mRNA疫苗完全免疫。参与者被随机分配接受ARCT 154或Comirnaty的增强剂量。

Immune responses were measured as neutralizing antibodies against the Wuhan-Hu-1 and Omicron BA.4-5 strains in sera obtained at Day 1 before booster vaccination, and Days 29, 91, 181, and 361 after vaccination of participants who were seronegative for SARS-CoV-2 nucleocapsid protein (N-protein), considered to be an indicator of recent COVID-19 infection.

在加强疫苗接种前第1天和接种SARS-CoV-2核衣壳蛋白（N蛋白）血清阴性的参与者接种后第29,91181和361天获得的血清中，测量免疫应答作为针对武汉-Hu-1和Omicron BA.4-5菌株的中和抗体，被认为是近期COVID-19感染的指标。

At the same timepoints neutralizing antibodies against Delta, Omicron BA.2, Omicron BA.2.86, and Omicron XBB.1.5.6 variants were measured in subsets of participants (~30 per group). Responses are expressed as group geometric mean titers (GMT) with 95% confidence intervals, and geometric mean titer ratio (GMTR) between the two vaccine groups at each timepoint..

同时，在参与者亚组（每组约30个）中测量了针对Delta，Omicron BA.2，Omicron BA.2.86和Omicron XBB.1.5.6变体的中和抗体。反应表示为95%置信区间的组几何平均滴度（GMT）和每个时间点两个疫苗组之间的几何平均滴度比（GMTR）。。

At Day 29, neutralizing antibodies (GMTs unadjusted) against the Wuhan-Hu-1 strain in ARCT 154 recipients (n = 378) were superior to those in the Comirnaty group (n = 374): GMT = 5390 (95% CI: 4899–5931) vs. 3738 (3442–4060), a GMT ratio of 1.44 (1.27–1.64). This advantage persisted through all time points.  At Day 361 (unadjusted) GMTs were 3396 (3019–3821) and 1771 (1532–2047) in ARCT 154 (n = 272) and Comirnaty (n = 266) groups, a GMT ratio of 1.92 (1.59–2.31).

在第29天，ARCT 154受体（n=378）中针对武汉Hu-1菌株的中和抗体（未调整的GMT）优于Comirnaty组（n=374）：GMT=5390（95%CI:4899-5931）与3738（3442-4060），GMT比为1.44（1.27-1.64）。这种优势在所有时间点都持续存在。在第361天（未调整），ARCT 154（n=272）和Comirnaty（n=266）组的GMT分别为3396（3019-3821）和1771（1532-2047），GMT比为1.92（1.59-2.31）。

Differences were also observed in responses against Omicron BA.4-5, with GMT ratios of 1.31 (1.07–1.59) at Day 29 and 1.89 (1.42– 2.50) at Day 361. A subset of subjects who were seronegative for N-protein displayed similar differences in immune responses between ARCT 154 and Comirnaty against the Delta, Omicron BA.2, BA.2.86, and XBB.1.5.6 variants at Day 361.

对Omicron BA.4-5的反应也存在差异，第29天的GMT比为1.31（1.07-1.59），第361天的GMT比为1.89（1.42-2.50）。在第361天，对N蛋白呈血清阴性的一部分受试者在ARCT 154和Comirnaty之间对Delta，Omicron BA.2，BA.2.86和XBB.1.5.6变体的免疫反应方面表现出相似的差异。

The GMT ratios were 1.88 (0.79–4.49) against Delta, 2.34 (1.06–5.17) against Omicron BA.2, 2.51 (1.00–6.31) against Omicron BA.2.86 and 2.81 (1.09–7.28) against Omicron XBB.1.5.6.

GMT对Delta的比率为1.88（0.79-4.49），对Omicron BA的比率为2.34（1.06-5.17）。对Omicron BA.2.86的比率为2.51（1.00-6.31），对Omicron XBB的比率为2.81（1.09-7.28）。1.5.6。

Bivalent 6-month Study Design and Results; In this randomized, multicenter, Phase III, observer-blind, active-controlled trial in Japan, fully-immunized (3‒5 doses of mRNA vaccine) adults were randomized 1:1 to receive a booster dose of ARCT 2301 or Comirnaty Original/BA.4-5. The primary objective was to demonstrate non-inferiority of the immunogenicity of ARCT-2301 vs.

二价6个月的研究设计和结果；在日本的这项随机，多中心，III期，观察者盲，主动对照试验中，完全免疫（3-5剂mRNA疫苗）的成年人以1:1的比例随机接受增强剂量的ARCT 2301或Comirnaty Original/BA.4-5。主要目的是证明ARCT-2301与。

Comirnaty Original/BA.4-5 at Day 29 as neutralizing antibody GMT and seroresponse rates (SRR) against Omicron BA.4-5. Key secondary outcomes included titers of neutralizing antibodies against Wuhan-Hu-1 and Omicron XBB.1.5..

Comirnaty Original/BA.4-5在第29天作为中和抗体GMT和针对Omicron BA.4-5的血清反应率（SRR）。关键的次要结果包括针对武汉Hu-1和Omicron XBB.1.5的中和抗体滴度。。

Between September and November 2023, 930 men and women (19‒80 years) with at least three prior mRNA COVID-19 vaccinations were enrolled at nine medical centers in Japan and administered ARCT 2301 (n = 465) or Comirnaty Original/BA.4-5 (n = 465) boosters. At Day 29 ARCT 2301 (n = 398) induced superior neutralizing antibody responses vs.

2023年9月至11月，日本9家医疗中心招募了930名男性和女性（19-80岁），其中至少有三次接种过新型冠状病毒肺炎疫苗，并给予ARCT 2301（n=465）或Comirnaty Original/BA.4-5（n=465）助推器。在第29天，ARCT 2301（n=398）诱导了优越的中和抗体反应。

Comirnaty (n = 405) against Omicron BA.4-5 (GMT ratio 1•49 [95% CI: 1.26–1.76], SRR difference 7.2% [95% CI: 0.6–13.7]), and against Wuhan-Hu-1 (GMT ratio 1.45 [1.28–1.63], SRR difference 12.5% [5.9–19.0]). The difference persisted through six months with GMT ratios of 2.17 (95% CI: 1.75-2.69) and 1.98 (95% CI: 1.69-2.31), respectively.

Comirnaty（n=405）对抗Omicron BA.4-5（GMT比1.49[95%CI:1.26-1.76]，SRR差异7.2%[95%CI:0.6-13.7]），对抗武汉胡-1（GMT比1.45[1.28-1.63]，SRR差异12.5%[5.9-19.0]）。这种差异持续了六个月，GMT比率分别为2.17（95%CI:1.75-2.69）和1.98（95%CI:1.69-2.31）。

Antibody responses against Omicron XBB.1.5 were also higher after ARCT 2301 vs. Comirnaty (GMT ratio 1.63 [1.36–1.94], SRR difference 16.7% [10.1–23.2])..

ARCT 2301与Comirnaty相比，针对Omicron XBB.1.5的抗体反应也更高（GMT比1.63[1.36-1.94]，SRR差异16.7%[10.1-23.2]）。。

About sa-mRNAmRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response..

关于sa-mRNAmRNA疫苗通过为体内细胞提供蓝图来制造蛋白质，帮助我们的免疫系统识别和对抗疾病，从而有助于预防传染病。与标准的mRNA疫苗不同，自我扩增的mRNA疫苗指导身体产生更多的mRNA和蛋白质来增强免疫反应。。

Condition: Coronavirus/COVID-19 Infection

条件：冠状病毒/新型冠状病毒19感染

Type: drug

类型：药物