A Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1019 in Healthy Adults

This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the bivalent SCB-1019 vaccine candidate with or without aluminium hydroxide in young adults (18-59 years) and older adults (60-85 years).

开始日期2023-12-13

申办/合作机构

Clover Biopharmaceuticals Aus Pty Ltd.

100 项与 RSV F antigen vaccine (Clover Biopharmaceuticals) 相关的临床结果

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100 项与 RSV F antigen vaccine (Clover Biopharmaceuticals) 相关的转化医学

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100 项与 RSV F antigen vaccine (Clover Biopharmaceuticals) 相关的专利（医药）

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项与 RSV F antigen vaccine (Clover Biopharmaceuticals) 相关的文献（医药）

2003-10-01·Vaccine3区 · 医学

Phase II safety and immunogenicity study of type F botulinum toxoid in adult volunteers*1

3区 · 医学

Article

作者: Sacared A Bodison ; Michael O'Donnoghue ; Steven S Wasserman ; Robert Edelman ; Judith G Perry ; Louis J DeTolla

An aluminum hydroxide (alum)-adsorbed, purified, botulinum F toxoid (Bot F) vaccine was manufactured to be administered as a stand-alone monovalent vaccine or to be added to the current botulinum pentavalent toxoid vaccine to make a hexavalent vaccine. We conducted a phase II trial of the Bot F vaccine over 3 years in 144 healthy adult volunteers to identify one of three vaccination schedules that was safe and maximally immunogenic for adult volunteers. We vaccinated 116 volunteers 1-3 times with Bot vaccine, and 28 volunteers 1-3 times with a licensed, alum-adsorbed hepatitis B vaccine (Engerix-B) as a reaction control group. After 1 year, 42 Bot volunteers with low, mouse anti-toxin titers (<0.10 IU/ml) received a booster injection and were followed for an additional year. The Bot vaccine inoculated three times over 28-42 days was generally well tolerated and safe, whether injected by the subcutaneous (s.c.) or intramuscular (i.m.) route, although it caused significantly more local reactions than did the HBV vaccine. Two vaccination schedules of three primary injections over 42 days (days 0, 14 and 42 or days 0, 21 and 42) provided significantly better protective immunity (anti-toxin levels >0.02 IU/ml) than did vaccinations given over 28 days (days 0, 7 and 28). Vaccine reactogenicity and immunogenicity were similar over 42 days whether administered subcutaneously or intramuscularly. However, even the most immunogenic schedule left 7-16% of volunteers unprotected at day 56 and 33-42% of vaccinees unprotected at 1 year. The booster dose administered at 1 year induced high levels of protective serum anti-toxin in all persons assayed which persisted for at least one additional year. A more potent vaccine formulation will be required to protect more individuals after primary immunization.

1994-07-01·Avian diseases4区 · 农林科学

Analysis and Characterization of Mycoplasma gallisepticum Isolates from Pennsylvania

4区 · 农林科学

Article

作者: Mark W. Jackwood ; Stanley H. Kleven ; Penelope S. Gibbs

Because Mycoplasma gallisepticum F strain vaccine can be pathogenic in chickens and is pathogenic in turkeys, we monitored the spread of MG F strain into unvaccinated flocks by screening field and experimental isolates. Thirteen MG isolates obtained from various sources in Pennsylvania were screened using several techniques capable of differentiating between MG strains. DNA restriction enzyme analysis (REA), Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) protein profiles, non-isotopic DNA probes, and a monoclonal antibody specific for F strain were used to characterize each of the 13 isolates. Three of the 13 isolates were identical to F strain; two of these were obtained from challenge studies, and one was a field isolate from a multiple-age commercial egg farm where the F strain vaccine had been used in the past. The remaining 10 isolates were different from MG F strain but were quite similar if not identical to each other according to REA; SDS-PAGE protein profiles show similarities between the 10 isolates. The results suggested that F strain vaccine is not a major cause of field outbreaks of MG in Pennsylvania.

1988-01-01·Avian pathology : journal of the W.V.P.A2区 · 农林科学

Examination ofmycoplasma gallisepticumstrains using restriction endonuclease DNA analysis and DNA‐DNA hybridisation

2区 · 农林科学

Article

作者: C.J. Morrow ; G.F. Browning ; K.G. Whithear ; D.M. Bulach ; S.H. Kleven ; E. Ghiocas

DNA from 10 Mycoplasma gallisepticum strains and one strain each of M. synoviae and M. gallinarum were studied by restriction endo-nuclease DNA analysis using endonucleases Eco RI, HindIII, BglII, BamHI, KpnI, and XhoI. Digestion patterns of DNA in agarose gels allowed easy differentiation of M. gallisepticum strains from different sources, while patterns obtained from one strain at the 6th and 100th in vitro passage levels were identical. The F strain and a field derivative obtained from a poultry farm where F strain vaccine had been previously used had almost identical patterns. This technique should be useful for comparing and differentiating M. gallisepticum strains in epidemiological and other studies. Strain differences were also noted by DNA-DNA hybridisation using a probe containing mycoplasma ribosomal RNA genes.

项与 RSV F antigen vaccine (Clover Biopharmaceuticals) 相关的新闻（医药）

2024-06-20

·美通社

三叶草生物公布其二价RSV候选疫苗SCB-1019 Ⅰ 期临床试验老年人群组获得积极初步数据

-- 二价 RSV候选疫苗SCB-1019诱导的 RSV-A 和 RSV-B 中和抗体滴度水平在老年人群组中显著提高，分别达到约7,900 IU/mL（提升高达8倍）和约46,700 IU/mL（提升高达11倍）-- -- 良好的安全性和反应原性数据，与生理盐水安慰剂组数据相当 -- -- 完整的 Ⅰ 期临床试验数据计划于2024年年底前获得 -- 2024年6月18日 - 致力以创新型疫苗拯救生命和改善全球健康水平的处于商业化阶段的全球生物制药公司——三叶草生物制药有限公司（以下简称"三叶草生物"；香港联交所股票代码：02197）今天公布，在评估公司基于三叶草生物独有的Trimer-Tag（蛋白质三聚体化）疫苗技术平台开发的二价RSV PreF-三聚体亚单位候选疫苗SCB-1019的 Ⅰ 期临床试验中，老年人群组获得了积极的初步免疫原性和安全性数据。这些在老年人群组（60-85岁）中获得的初步数据和今年4月公司公布的于年轻成年人群组（18-59岁）中获得的积极数据一致。 "作为中国首款进入临床试验阶段并获得积极临床数据的RSV PreF（基于融合前构象的F蛋白）候选疫苗，SCB-1019在老年人群组中的 Ⅰ 期临床试验中显示出针对RSV-A和RSV-B两个病毒亚型广谱且显著的中和抗体反应，以及良好的耐受性，" 三叶草生物首席执行官兼执行董事梁果先生表示，"我们期待在2024年年底前获取完整的 Ⅰ 期临床试验数据，以支持我们二价RSV候选疫苗SCB-1019的进一步开发，并增强我们该款产品在全球市场潜在的差异化竞争优势。" 在正在进行的 Ⅰ 期临床试验中，48名受试者入组了老年人群组，分别接种了SCB-1019或生理盐水安慰剂。应用既定的剂量水平，SCB-1019的RSV中和抗体（nAbs）和安全性初步数据总结如下： RSV-A中和抗体：接种后第 28 天，SCB-1019 诱导的 RSV-A 中和抗体的几何平均滴度 (GMT) 高达 7,906 IU/mL，而安慰剂组数据为 1,078 IU/mL。 RSV-B中和抗体：接种后第 28 天，SCB-1019 诱导的 RSV-B 中和抗体的几何平均滴度 (GMT) 高达 46,674 IU/mL，而安慰剂组数据为 12,185 IU/mL。几何倍数升高（GMFR）：观察到第0天（接种前）的中和抗体滴度基线值较高，尤其是针对 RSV-B，这可能反映了最近临床试验点附近暴发的RSV疫情。因此，对中和抗体滴度基线值最低四分位数的受试者进行了次级分析：第28天（接种后）相比第0天（接种前），SCB-1019的RSV-A中和抗体GMFR高达8倍，RSV-B中和抗体GMFR高达11倍。第28天（接种后），安慰剂组未观察到RSV-A或RSV-B中和抗体滴度的提升。与其他蛋白亚单位RSV PreF疫苗[1], [2], [3]相比，SCB-1019针对RSV-A和RSV-B的中和抗体滴度数据相当或可能更优；同时，基于之前观察到其他单价RSV-A疫苗对RSV-B的免疫反应和/或有效性较低[1], [4], [5]，这进一步支持三叶草生物选择开发二价 RSV-A/B PreF 疫苗的策略。临床试验的初步数据进一步证实，SCB-1019中的PreF抗原是稳定的融合前构象和三聚体结构，同时探索性的免疫原性结果显示出的在中和位点Ø和中和位点V抗体竞争滴度显著增加，也佐证了这一点。 SCB-1019的耐受性总体良好。SCB-1019的局部和全身不良事件（AEs）通常较轻，与生理盐水安慰剂组相当。未观察到严重不良事件（SAEs）、特殊关注的不良事件（AESIs）或AEs导致停药的不良事件。结果显示，与目前已获批的水包油佐剂[4]和/或基于mRNA[5]技术的RSV疫苗相比，SCB-1019在安全性和反应原性方面可能具有差异化优势。在澳大利亚进行的 Ⅰ 期临床试验是一项随机、安慰剂对照的研究，目的是评估SCB-1019在年轻成年人和老年人群中不同剂型、不同剂量水平下的安全性、反应原性和免疫原性。Ⅰ 期临床试验的完整安全性和免疫原性结果预计将于2024年年底前公布，以支持该二价RSV候选疫苗SCB-1019的进一步开发，并增强其在全球市场潜在的差异化竞争优势。 [1] Icosavax Company Presentations (28-JUN-2022 & 22-MAY-2023) and Press Release (12-DEC-2023) [2] NIH DS-Cav1 (DOI: 10.1016/S2213-2600(21)00098-9) [3] Pfizer (DOI: 10.1093/infdis/jiab612) [4] GSK ACIP Presentation (21-JUN-2023) [5] Moderna ACIP Presentation (29-FEB-2024) 三叶草生物是一家处于商业化阶段的全球生物制药公司，致力以创新型疫苗拯救生命和改善全球健康水平。凭借综合研发实力、生产和商业化能力，以及与分布全球的相关机构强大的合作伙伴关系，我们已经开发出多样化的候选疫苗管线，以期我们的疫苗可使更多疾病得到预防，助力减轻公共卫生的负担。内容来源于网络，如有侵权，请联系删除。

疫苗临床终止

2024-06-18

·PRNewswire

Clover Announces Positive Preliminary Phase Ⅰ Results for Bivalent RSV Vaccine Candidate SCB-1019 in Older Adults

-- Bivalent SCB-1019 significantly boosted RSV-A and RSV-B neutralizing antibody titers in older adults up to approximately 7,900 IU/mL (up to 8-fold increase) and approximately 46,700 IU/mL (up to 11-fold increase), respectively -- -- Favorable safety & reactogenicity profile comparable to saline placebo -- -- Full Phase Ⅰ data readout is planned by year-end 2024 -- SHANGHAI, June 18, 2024 /PRNewswire/ -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced positive preliminary immunogenicity and safety data in the older adult & elderly cohort from its Phase Ⅰ trial evaluating SCB-1019 – the company's bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate – which is based on Clover's Trimer-Tag vaccine technology platform. These preliminary results in older adults & elderly cohort (aged 60-85) are consistent with the positive results in younger adults (aged 18-59) announced earlier this year. "As the first RSV PreF vaccine candidate developed in China to enter the clinical trial stage and generate clinical data, SCB-1019 Phase Ⅰ results in older adults demonstrate broad and significant neutralizing antibody responses against both RSV-A and RSV-B as well as a favorable tolerability profile," said Joshua Liang, Chief Executive Officer & Board Director of Clover. "We look forward to the full Phase Ⅰ clinical readout by the end of 2024 to support further development and strengthen our potentially differentiated profile for markets globally." In the ongoing Phase Ⅰ trial, 48 subjects were enrolled in the older adult & elderly cohort and received either SCB-1019 or saline placebo. Preliminary results for RSV neutralizing antibodies (nAbs) and safety for SCB-1019 at the selected dose-level are summarized below: Immunogenicity Results RSV-A nAbs: SCB-1019 induced geometric mean titers (GMTs) in RSV-A nAbs of up to 7,906 IU/mL compared to 1,078 IU/mL for placebo at Day 28. RSV-B nAbs: SCB-1019 induced geometric mean titers (GMTs) in RSV-B neutralizing antibody titers (nAbs) of up to 46,674 IU/mL compared to 12,185 IU/mL for placebo at Day 28. Geometric Mean Fold Rise (GMFR): High baseline nAb titers at Day 0 (pre-vaccination), especially to RSV-B, were observed, potentially reflecting recent outbreaks near the clinical trial sites. Thus, sub-analysis in subjects with the lowest quartile baseline nAb titers was performed: GMFRs for SCB-1019 were up to 8-fold for RSV-A nAbs and 11-fold for RSV-B nAbs at Day 28 compared to Day 0 (pre-vaccination). No increases in RSV-A or RSV-B nAbs were observed for placebo at Day 28. nAb results across both RSV-A and RSV-B appear to be in-line or potentially favorable compared to other protein subunit RSV PreF vaccines1, 2, 3 and continue to be supportive of Clover's bivalent RSV-A/B approach, given that other monovalent RSV-A vaccines have previously observed lower immune responses and/or efficacy against RSV-B 1, 4, 5. Results further confirm that Clover's PreF antigens in SCB-1019 are in the stabilized prefusion and trimeric form, additionally supported by exploratory immunogenicity results demonstrating significant increases in Site Ø and Site V nAb-competitive titers. Safety & Reactogenicity Results SCB-1019 was generally well-tolerated. Local and systemic adverse events (AEs) were generally mild for SCB-1019 and were comparable to saline placebo. No serious adverse events (SAEs), adverse events of special interest (AESIs), or AEs leading to discontinuation were observed. Results indicate that SCB-1019 could potentially have a differentiated and favorable safety & reactogenicity profile compared to currently-approved oil-in-water adjuvanted4 and/or mRNA5-based RSV vaccines. The Phase Ⅰ clinical trial in Australia is a randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of SCB-1019 at multiple dose levels and in different formulations in young and older adults. Full safety and immunogenicity results in the Phase Ⅰ clinical trial are expected by the end of 2024 to support further development and strengthen our potentially differentiated profile for markets globally. About Clover Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable.  Clover Forward-looking Statements This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used, the words "aim," "anticipate," "believe," "could," "estimate," "expect," "going forward," "intend," "may," "might," "ought to," "plan," "potential," "predict," "project," "seek," "should," "will," "would" and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time. Clover Biopharmaceuticals: Corporate Communication: Lola Cao [email protected] Investor Relations: Michael Tu [email protected] SOURCE Clover Biopharma

临床结果疫苗临床2期

2024-04-24

·精准药物

第一批吃到螃蟹的药企

第一批开悟的药企，已率先享受RSV药物的时代红利。作为RSV药物的商业化元年，2023年有2款RSV疫苗和1款预防抗体药物合计斩获30亿美元销售额。随着市场竞争大幕缓缓拉开，更多药企持续开悟中。01国产不再“静悄悄”就中国市场而言，RSV药物赛道可谓是“蓝海中的蓝海”。目前，全球已获批的3款RSV药物，仅赛诺菲/阿斯利康的Beyfortus（尼塞韦单抗）于今年1月在中国上市，而GSK的Arexvy尚处于Ⅰ期临床，预计2026年实现商业化落地。尽管国内市场尚处于萌芽阶段，但潜力巨大。据灼识咨询数据，到2030年，中国RSV药物市场规模预计增至15亿美元，年复合增长率高达75.8%，远超全球同期增速（21.4%）。其中，针对儿童的RSV药物预计约占整个中国RSV药物市场的89.4%。这无疑吸引了众多国产企业布局，包括艾棣维欣、三叶草生物、沃森生物、艾美疫苗、智飞生物等，多数技术路线为已验证成药性的重组蛋白和mRNA。图片来源：中航证券研报进度最快的是艾棣维欣重组蛋白亚单位疫苗ADV110（BARS13），针对60-80岁老年人的II期临床试验，以及针对18-45岁成人的I期临床试验，均显示出良好的安全性、耐受性和免疫原性。三叶草生物基于其独有的Trimer-Tag（蛋白质三聚体化）疫苗技术平台开发的二价重组蛋白RSV候选疫苗SCB-1019，在针对18-59岁成人的I期试验中取得了积极初步数据。另外，处于临床早期阶段的还有康乐卫士、康泰生物布局的重组蛋白疫苗，以及百克生物布局的重组亚单位疫苗。mRNA疫苗方面，艾美疫苗、沃森生物/蓝鹬生物、石药集团和嘉晨西海等均已布局，目前处于临床早期阶段。值得一提的是，智飞生物与GSK于去年10月签订了在中国独家销售带状疱疹疫苗Shingrix的合作，同时还就后者的RSV疫苗Arexvy达成初步合作意向。除此以外，也有一些国产企业选择布局RSV预防药物。例如，爱科百发的RSV抗病毒特效药AK0529已向国家药监局递交上市申请，用于治疗婴幼儿、成人患者中RSV感染，有望成为全球首个获批的特效抗RSV病毒感染的临床药品；智翔金泰研发的重组RSV单抗GR2102，于今年2月获批临床，拟用于预防RSV感染。02全球争夺“大蛋糕”据不完全统计，目前全球有近70条在研RSV预防管线，涉及技术路线包括减毒活疫苗、亚单位疫苗、mRNA疫苗和针对不同病毒蛋白的重组载体候选疫苗，参与者不乏强生、默沙东等MNC巨头。其中，Moderna的mRNA-1345进展最快，对60岁以上老人效果显著，目前已申请在欧盟、瑞士、澳大利亚和美国等多地上市，并开展了针对儿科人群的临床试验。格外值得一提的是，已拥有RSV预防药物的阿斯利康，也顺势打入了RSV疫苗赛道：于2023年底斥资11亿美元溢价收购Icosavax，后者的核心产品IVX-A12是一种针对RSV和人偏肺病毒（hMPV）的潜在FIC的VLP组合候选疫苗，已被FDA授予针对60岁以上成人的快速通道资格，可与Synagis和Beyfortus形成互补，覆盖更多人群，且即将开展Ⅲ期临床试验。除技术创新外，一些企业还选择开发疫苗联合疗法。例如，近日GSK启动了RSV重组蛋白疫苗+新冠mRNA疫苗联合免疫的三期临床试验；Moderna也布局了一款流感/新冠/RSV三联mRNA疫苗mRNA-1230，目前处于临床前阶段。RSV预防药物的在研管线也不在少数，包括默沙东的clesrovimab、珠海泰诺麦博TNM001和赛诺菲的gontivimab等，均已处于临床Ⅱ期及以上阶段。从上述管线的进度不难看出，未来几年RSV药物的市场竞争将进入白热化阶段。全球RSV抗体管线丰富图片来源：开源证券研报由于RSV可感染广泛人群，扩大适用年龄范围成为推动RSV疫苗增长的关键。这点与HPV疫苗类似。默沙东的九价HPV疫苗之所以能爆卖，正是由于扩龄策略，将适用人群从16-26岁拓展至9-45岁适龄女性，使得潜在消费者基数大幅增加，市场空间实现了翻倍。除了老年人，RSV疫苗的适用人群还在持续拓展。今年1月底，欧盟已受理GSK的Arexvy扩龄至50-59岁成人的上市申请，预计今年下半年可获批上市。只是很可惜，Arexvy针对婴幼儿和孕妇的临床试验均未成功。另一边，辉瑞的Abrysvo也在扩龄：去年8月获得FDA批准新增胎龄32-36周孕妇适应症，以保护新生儿免受RSV感染。而且，Abrysvo针对18-59岁人群的III期研究已经成功，即将申请上市，同时正在开展针对2-17岁高危儿童及青少年的Ⅲ期临床试验。可见，无论GSK还是辉瑞，都在想方设法攻克儿童人群，尤其5岁以下婴幼儿。毕竟，该年龄段是RSV的最核心易感人群，市场前景更佳。据灼识咨询数据显示，针对儿童的RSV药物预计2030年将增至117亿美元，将占全球RSV药物市场的91.1%。基于此，不少药企布局了儿童RSV疫苗，包括赛诺菲的鼻喷减毒活疫苗LID/ΔM2-2/1030s（Ⅲ期，预计2026年提交上市申请）、BlueLake（蓝湖生物）的BLB-201（Ⅱ期）等。值得一提的是，赛诺菲的LID/ΔM2-2/1030s可以保护新生儿在第二个RSV流行季（次年4月-次年9月）不受感染，而与阿斯利康联合研发的Beyfortus，可保护新生儿在第一个RSV流行季（当年10月-次年3月）不受感染，可谓进行了全方位的布局。图片来源：民生证券研报03百亿美元赛道作为新晋明星赛道，RSV疫苗市场需求大、增长潜力足，被誉为“下一个HPV疫苗”。呼吸道合胞病毒（RSV）感染范围广泛，具有明显的季节性，尤其在秋末初冬时高发，对所有年龄段的人群都构成威胁，特别是婴幼儿、成年免疫缺陷者和老年人等高危人群。根据WHO统计数据显示，RSV每年导致全球约6400万儿童感染、36万成人入院。针对RSV感染的治疗，主要分为主动免疫（RSV疫苗）和被动免疫（RSV预防药物）两种治疗手段。1998年，诞生了全球首款RSV预防药物，MedImmune公司（后被阿斯利康收购）研发的Synagis（帕利珠单抗）获FDA批准上市，用于预防早产儿RSV引起的下呼吸道疾病。但由于价格昂贵、覆盖病患群体小（仅在美国获批用于治疗早产儿），且需每月注射一次，直到上市后的第10年，Synagis才跻身“重磅炸弹药物”行列。近两年，RSV预防药物迎来了重大突破：由阿斯利康和赛诺菲联合开发的Beyfortus（尼塞韦单抗），分别于2022年、2023年获欧盟、FDA批准上市，用于预防婴幼儿RSV引起的下呼吸道疾病。图片来源：平安证券研报相较之下，RSV疫苗的研发之路更加坎坷，耗时60多年才终于迎来曙光。2023年5月，葛兰素史克（GSK）的Arexvy、辉瑞的二价RSV疫苗Abrysvo相继获FDA批准上市，用于预防60岁及以上人群由RSV引起的下呼吸道疾病。至此，2023年成为了RSV药物的商业化元年，且销售表现不俗。其中，Arexvy仅销售7个月便大卖15.66亿美元，Abrysvo在6个月的时间实现销售额8.9亿美元，Beyfortus的营收也达到了5.98亿美元。GSK预测，Arexvy销售峰值将超过30亿英镑，彰显RSV疫苗市场的巨大潜力。由于感染广泛、疾病负担重、市场尚处蓝海，RSV药物市场具备百亿美元级别的潜力。据灼识咨询研究数据显示，RSV药物全球整体市场规模预计到2030年将增长至128亿美元。参考资料：1.各家公司的财报、公告、官微2.《11亿美元AZ入新局，与辉瑞、GSK开启“三国杀”？RSV赛道谁是国内第一玩家？》，E药经理人，2023-12-163.平安证券、民生证券、开源证券、中航证券研报声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 金银花转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

疫苗临床1期信使RNA临床2期

100 项与 RSV F antigen vaccine (Clover Biopharmaceuticals) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
呼吸道合胞体病毒感染	临床1期	澳大利亚	四川三叶草生物制药有限公司	2023-12-12

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06194318 (NEWS) 人工标引	临床1期	呼吸道合胞体病毒感染	48	SCB-1019	選壓艱淵積淵艱願餘壓(網製衊顧鏇願簾廠簾製) = CB-1019的局部和全身不良事件（AEs）通常较轻，与生理盐水安慰剂组相当。構窪醖繭膚簾顧鑰齋膚 (遞夢範蓋顧網襯壓遞窪 ) 更多	积极	2024-06-18
				Placebo
Phase I trial (PRNewswire) 人工标引	临床1期	呼吸道合胞体病毒感染	-	SCB-1019	窪選齋願衊衊觸積選醖(夢膚鹽醖蓋衊觸襯壓衊) = 獵構壓顧顧觸觸顧廠壓繭膚簾廠繭簾餘憲衊蓋 (繭壓艱獵餘襯製艱鬱製 ) 更多	积极	2024-04-08
				SCB-1019 (GMT (Day 0))	窪選齋願衊衊觸積選醖(襯憲積艱憲壓範積範獵) = 製鹹願夢艱鹽膚蓋窪夢繭憲顧夢衊齋鹹醖窪衊 (獵鹹觸鏇鹹襯齋鏇製夢 ) 更多