Respiratory Syncytial Virus Vaccine (GSK)

-- Results indicate potential best-in-class RSV+hMPV±PIV3 combination vaccines, with the potential ability to re-vaccinate individuals previously receiving approved RSV vaccines to restore and broaden protection -- -- Increases in neutralizing antibodies of approximately 6-8 fold for RSV, 6-9 fold for hMPV and 4 fold for PIV3 (≥10 fold increases in PIV3 PreF-specific antibodies) were observed -- -- Interim analysis from RSV re-vaccination trial demonstrates ≥60% higher trend in RSV neutralizing antibodies for Clover's RSV vaccine compared head-to-head versus AREXVY (GSK) in older adults previously receiving an initial dose of AREXVY -- -- Potential first-in-class RSV+hMPV±PIV3 combination vaccine candidates to advance to Phase II clinical trials in the first half of 2026 -- SHANGHAI, Oct. 14, 2025 /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 data from two ongoing clinical trials evaluating the company's combination respiratory PreF vaccine candidates (RSV+hMPV±PIV3) leveraging its validated Trimer-Tag platform technology including: A Phase I trial in Australia evaluating SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) combination vaccines compared head-to-head with SCB-1019 (RSV) in RSV vaccine-naïve older adults; and, A Phase I trial in the U.S. evaluating re-vaccination with SCB-1019 compared head-to-head versus AREXVY (GSK's RSV vaccine) in older adults previously receiving AREXVY at least 2 seasons prior to enrolling. "We are pleased to announce positive Phase I clinical data indicating a potential best-in-class profile for our RSV+hMPV±PIV3 combination vaccine candidates, with the potential ability to re-vaccinate individuals previously receiving approved RSV vaccines to restore and broaden protection," said Joshua Liang, Chief Executive Officer & Board Director of Clover. "While currently approved protein-based RSV vaccines are safe & effective, critical gaps persist globally, including (1) the inability to prevent significant respiratory disease burden caused by other viruses related to RSV such as human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) and (2) the inability to re-vaccinate effectively when protection against RSV disease wanes. We look forward to advancing our RSV+hMPV±PIV3 combination vaccines into Phase II clinical trials in the first half of 2026 to strengthen our potential first-in-class and best-in-class profile." RSV+hMPV±PIV3 Combination Vaccines Phase I Trial (Australia) : Preliminary Full Results In an ongoing Phase I trial in Australia, older adults (60-85 years) were enrolled and randomized to receive either SCB-1022 (RSV+hMPV), SCB-1033 (RSV+hMPV+PIV3) or SCB-1019 (RSV) comparator. The study is assessing safety, reactogenicity and immunogenicity, with preliminary results from 144 participants (48 participants per vaccine group) at the selected dose levels summarized below: RSV Immune Responses: Geometric mean fold rises (GMFRs) of approximately 6-8 fold in RSV-A and RSV-B neutralizing antibodies (nAbs) at 28 days post-vaccination were observed for both SCB-1022 and SCB-1033, which were in-line with the SCB-1019 comparator (and also in-line with previous results from a separate clinical trial conducted by Clover comparing SCB-1019 head-to-head versus AREXVY). No signs of immune interference on RSV nAb responses from the addition of hMPV and PIV3 PreF antigens in the RSV+hMPV±PIV3 combination vaccines were observed. hMPV Immune Responses: GMFRs of approximately 6-7 fold in hMPV-A nAbs and approximately 8-9 fold in hMPV-B nAbs were observed for both SCB-1022 and SCB-1033. PIV3 Immune Responses: GMFRs of approximately 4 fold in total PIV3 nAbs was observed for SCB-1033, along with ≥10 fold increases in PIV3 PreF-specific antibodies (against Site Ø and Site X) confirming that the PreF-specific antibody responses against PIV3 are likely at least in-line with responses observed for RSV and hMPV. In participants with pre-existing baseline PIV3 nAb levels in the bottom 50th percentile, GMFRs of approximately 6 fold in PIV3 nAbs was observed for SCB-1033, suggesting stronger responses in people who may be most at-risk for infection and disease. PIV3 PreF-specific nAbs (such as Site Ø and Site X) can potently neutralize the PIV3 virus[1], but unlike RSV and hMPV, the majority of pre-existing PIV3 nAbs at baseline are against the PIV3 HN protein (whereas levels of pre-existing PIV3 nAbs against the PIV3 PreF protein at baseline are low)[2]. Therefore, a numerically lower increase in total PIV3 nAbs induced by SCB-1033 (containing PIV3 PreF antigen) – as compared to increases in RSV and hMPV nAbs – is expected. Safety and Reactogenicity: SCB-1022 and SCB-1033 were generally well-tolerated. Local and systemic AEs were generally mild for SCB-1022 and SCB-1033 and were comparable to SCB-1019, which had previously demonstrated significantly better tolerability than AREXVY in a separate trial. No vaccine related serious adverse events (SAEs), adverse events of special interest (AESIs), or AEs leading to discontinuation were observed for SCB-1022, SCB-1033 or SCB-1019. Based on these positive Phase I results, Clover plans to advance SCB-1022 and SCB-1033 to Phase II clinical trials in the first half of 2026. RSV Re-Vaccination Phase I Trial (U.S.) : Preliminary Interim Analysis Results Enrollment is ongoing in a Phase I trial in the U.S. in older adults (60-85 years) who previously received an initial dose of GSK's RSV vaccine (AREXVY) at least 2 seasons prior. Participants are being randomized to receive either a heterologous SCB-1019 (Clover RSV PreF) revaccination dose, a homologous AREXVY (GSK RSV PreF) revaccination dose or saline placebo. The study is assessing safety, reactogenicity and immunogenicity. AREXVY homologous re-vaccination (when given at 2-3 years after the initial dose) has previously been reported to boost RSV nAbs only up to approximately 60-65% of the peak levels that were induced by the initial dose[3], implying that an incremental approximately 1.5x higher response induced by SCB-1019 heterologous re-vaccination (if observed) compared to AREXVY homologous re-vaccination may be able restore peak levels of RSV nAbs and protection. An interim analysis for immunogenicity in Clover's ongoing re-vaccination trial has been performed, and the preliminary results from 34 participants (16 participants receiving SCB-1019, 15 participants receiving AREXVY, 3 participants receiving saline placebo) are summarized below: RSV nAbs: SCB-1019 heterologous re-vaccination induced a 1.6-1.8x higher trend in GMFRs for RSV-A and RSV-B nAbs compared to AREXVY homologous re-vaccination, with approximately double the percentage of participants observing increases in RSV nAbs (≥2-fold): GMFRs in RSV nAbs: Approximately 3.0-3.3 fold GMFRs in RSV-A and RSV-B nAbs were induced in participants receiving SCB-1019, as compared to 1.8-1.9 fold for AREXVY and no increases for placebo. % of Participants with Increases in RSV nAbs: 69-75% of participants receiving SCB-1019 observed ≥2-fold increases in RSV-A and RSV-B nAbs, as compared to 33-40% for AREXVY and 0% for placebo. Randomization and Baseline Characteristics: The randomization of participants included in this interim analysis was consistent, with baseline characteristics (such as baseline RSV nAb titers, participant age, re-vaccination interval) in the SCB-1019 and AREXVY groups being highly comparable. Baseline RSV nAb titers prior to re-vaccination in this study appeared to be approximately 2-3 fold higher than baseline nAb titers in RSV vaccine-naïve older adults from other clinical trials and is consistent with the previously reported results for AREXVY at 2-3 years following the initial dose[3]. Given that more than 40% adults 60 years and older in the U.S. have previously received an protein-based RSV vaccine (comprising approximately 15 million doses)[4], and clinical data to-date for currently approved RSV vaccines have not supported RSV re-vaccination policy recommendations despite waning efficacy observed after the initial dose, these preliminary clinical data from Clover's interim analysis suggest the potential for Clover's RSV+hMPV±PIV3 combination vaccine candidates to both restore protection against RSV and broaden protection to hMPV±PIV3 in this population. Additional data from the ongoing RSV re-vaccination trial is expected by the first half of 2026. 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. 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摘要:咱们身边 65 岁以上的长辈越来越多了 ——2025 年数据显示，欧盟 65 岁以上人口已占 21.3%，80 岁以上的人未来 75 年还会增加 2.5 倍。但老年人的免疫系统会随年龄变弱（也就是 “免疫衰老”），普通疫苗效果打折扣，一旦感染流感、肺炎这些病，不仅容易住院，还可能留下走路没劲、记忆力下降的 “长期后遗症”，甚至增加心脏病、中风的风险。好消息是，2025 年最新研究里，老年人疫苗有了不少新突破：流感有高剂量疫苗，肺炎有 21 价新疫苗，带状疱疹疫苗保护率能到 97%，连之前没疫苗的 RSV（呼吸道合胞病毒）也有了新选择。今天就跟大家掰扯清楚，这些疫苗怎么选、怎么打，才能真的护好爸妈。 一、先搞懂：为啥老年人打疫苗，比年轻人更重要？ 很多人觉得 “爸妈身体好，不用打疫苗”，其实正好相反 —— 老年人感染一次，后果可能比年轻人严重 10 倍。 首先是 “免疫衰老” 在拖后腿：随着年龄增长，老年人的 B 细胞、T 细胞（都是免疫系统的 “战士”）活性会下降，就算打了疫苗，产生的抗体也少、消失得还快。比如普通流感疫苗，在年轻人里能防 70% 的感染，但老年人可能只能防 30%-50%。 更麻烦的是，老年人常伴有高血压、糖尿病、慢阻肺这些 “共病”，一旦感染，很容易引发并发症。比如有慢阻肺的老人，得社区获得性肺炎的风险，是普通人的 20 倍以上；加拿大一项研究还发现，65 岁以上老人住过流感院后，12% 会去世，20% 会变得走路需要人扶（11% 甚至彻底失去自理能力）。 更隐蔽的是 “长期后遗症”：感染不只是 “发烧几天就好” 这么简单。比如得了带状疱疹，3 个月后还疼的 “带状疱疹后神经痛（PHN）”，会让老人连穿衣服都疼；就算是普通肺炎，康复后几年内，心脏病、中风的风险也会升高 —— 有研究发现，流感确诊后第一周，心肌梗死的风险会增加 6 倍！ 所以对老年人来说，疫苗不只是 “防发烧”，更是在防残疾、防重病，甚至防死亡。二、这 5 种疫苗，老年人现在有 “升级版” 可选！ 以前老年人常打的只有流感、肺炎疫苗，现在不一样了，5 种高风险感染都有了更适合的疫苗，咱们一个个说：1. 流感疫苗：别再只打普通款，高剂量/佐剂款更管用 流感每年都会变花样（“抗原漂移”），所以得年年打，但普通疫苗对老年人效果一般。现在有两种更好的选择： 高剂量流感疫苗（HD-TIV）：抗原量是普通疫苗的 4 倍（每株 60μg vs 15μg），能让老年人产生更多抗体。研究显示，它比普通疫苗减少 24% 的肺炎住院、17.8% 的流感住院，法国 2021-22 年的数据还显示，它防流感住院的效果比普通疫苗好 23.3%。 佐剂流感疫苗（aTIV）：加了 “佐剂”（比如 MF59）的疫苗，能唤醒更多免疫细胞。这种疫苗不仅抗体多，还能识别 “变异的流感病毒”（比如 H3N2 漂移株），防实验室确诊流感的效果比普通疫苗好 63%（调整后比值比 0.37）。 另外，mRNA 流感疫苗也在试：就像新冠 mRNA 疫苗一样，它生产快，能更精准地匹配当年的流行株。比如候选疫苗 mRNA-1010，对甲型流感的抗体反应比普通疫苗强，还有厂家在研发 “流感 + 新冠” 二联疫苗，以后打一针能防两种病，省得爸妈跑两趟。2. 肺炎疫苗：最新 21 价疫苗，覆盖更全 肺炎球菌是老年人肺炎、脑膜炎的 “头号凶手”，美国每年有 3 万老年人得侵袭性肺炎球菌病（IPD），2.5 万人会去世。以前常用的是 23 价多糖疫苗（PPV-23），但现在有了 “结合疫苗” 的升级版： 从 PCV-13（13 价）到 PCV-15（15 价）、PCV-20（20 价），再到 2024 年美国获批、2025 年欧洲获批的PCV-21（21 价疫苗），覆盖的 “肺炎球菌血清型” 越来越多。 特别是 PCV-21，比 PPV-23 多了 8 种老年人易感的血清型（看下面的表），能防更多类型的肺炎。虽然还没有直接的 “防住院” 数据，但它产生的抗体，比老疫苗更强、更持久（尤其是对免疫弱的老人）。 表 1：肺炎球菌多糖疫苗（PPV）与结合疫苗（PCV）的血清型组成  3. 带状疱疹疫苗：选 “重组款”，保护率高、维持久 带状疱疹是 “水痘病毒复活” 引起的，50 岁后发病率会飙升，80 岁以上老人几乎一半都会得。以前的 “减毒活疫苗（Zostavax）” 效果一般，70 岁以上老人用，保护率不到 20%，现在推荐的是 “重组带状疱疹疫苗（Shingrix）”： 它加了 AS01B 佐剂，能激发更强的 T 细胞反应，50 岁以上老人用，保护率能到 97%，70 岁以上也能到 89.8%—— 几乎不会得带状疱疹。 更省心的是，它保护时间长，打两针后能维持 10 年以上，就算是身体弱的 “frail 老人”，效果也不会打折扣；免疫低下的老人（比如肾移植后、得白血病的）也能打，这是老疫苗做不到的。4. 新冠疫苗：别停在 “基础针”，booster（加强针）要跟上 虽然新冠死亡率下降了，但老年人还是高风险人群。现在的重点是 “及时打加强针”： 3 针疫苗后，防重症、防死亡的效果还能保持在 80% 以上，就算感染了，也不容易住 ICU。 现在有针对最新变异株的 “更新款疫苗”，而且厂家在研发 “新冠 + 流感 + RSV” 三联疫苗，以后可能打一针就能防三种呼吸道病毒，对记性不好的老人很友好。5. RSV 疫苗：终于有了！保护能维持 2 年 RSV（呼吸道合胞病毒）以前被忽视了，其实它是老年人冬季肺炎的 “隐形凶手”—— 工业化国家里，50 岁以上老人每年约 150 万感染 RSV，21.4 万人住院，1.6% 会去世。2023-2024 年，三种 RSV 疫苗终于获批： 有含佐剂的（如 GSK 的 Arexvy，加了 AS01E），也有不含佐剂的（如 Pfizer 的 Abrysvo），还有 mRNA 疫苗（Moderna 的 mRNA-1345）。 效果都不错：防下呼吸道感染（比如肺炎）的效果在 66.7%-83.7% 之间，而且能保护 2 年 —— 不用像流感那样年年打。美国的真实世界数据也显示，打了 RSV 疫苗的老人，住院风险能降 80%。三、疫苗里加 “佐剂”，到底是在 “加什么料”？ 前面总提到 “佐剂疫苗”，很多人会问：“加佐剂会不会有副作用？” 其实佐剂是疫苗的 “好帮手”，专门帮老年人克服 “免疫衰老”。 简单说，佐剂就是 “唤醒免疫系统的闹钟”：它能在注射部位吸引更多免疫细胞（比如 dendritic 细胞，相当于 “情报员”），让这些细胞更高效地把疫苗里的 “抗原”（相当于 “敌人照片”）传给 T 细胞、B 细胞，从而产生更多抗体、更强的免疫记忆。 现在常用的佐剂有两种： MF59：一种油包水乳化剂（含角鲨烯，和皮肤里的成分类似），常用在流感疫苗里。它能促进炎症因子释放，帮 dendritic 细胞成熟，让抗体维持更久。 AS01B：用在带状疱疹疫苗里，包含 MPL（脂多糖衍生物）和 QS-21（一种植物提取物），能激发更强的 T 细胞反应 —— 这对带状疱疹特别重要，因为防带状疱疹主要靠 T 细胞。 研究显示，加了佐剂的疫苗，不仅抗体多，还能让免疫反应更 “广谱”（比如防变异病毒），副作用和普通疫苗差不多，不用太担心。四、给家属的 3 个小提醒，别让疫苗 “白打” 别纠结 “要不要年年打”，按指南来：流感、新冠需要每年打（因为病毒会变异）；RSV、带状疱疹疫苗能管 2-10 年，不用年年打；肺炎疫苗打一次 PCV-21，一般不用补打（具体遵医嘱）。 记好 “疫苗记录”：把爸妈打疫苗的时间、类型记在手机里，下次去医院时带给医生看 —— 比如打了 PCV-21，就不用再打 PPV-23 了，避免重复接种。 别信 “身体弱不能打”：除了严重过敏，大部分老人就算有高血压、糖尿病，也能打疫苗。比如重组带状疱疹疫苗，肾移植、白血病患者都能打，反而这些人更需要保护。 最后想说，对老年人来说，疫苗是性价比最高的 “健康保险”—— 花几百块打一针，能避免几万块的住院费，还能让爸妈少遭罪。2025 年这些疫苗新进展，都是为了让老年人的疫苗 “不白打、打得值”。如果爸妈还没打今年的疫苗，赶紧查下当地社区医院的接种时间，别错过了～ 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。