A Long-term Follow-up Study to Evaluate Safety and Immunogenicity of a Chikungunya Virus Virus-like Particle Vaccine (PXVX0317) in Healthy Adults and Adolescents After Either a Single or Booster Vaccination Dosing Regimen

The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial CHIKV VLP vaccination.

开始日期2023-08-30

申办/合作机构

Bavarian Nordic A/S

NCT05349617

/ Completed临床3期

A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.

开始日期2022-05-12

申办/合作机构

Bavarian Nordic A/S

[+1]

NCT05065983

/ Completed临床2期

A Phase 2 Open-Label Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)

The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).

开始日期2021-10-11

申办/合作机构

Bavarian Nordic A/S

[+1]

100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的临床结果

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100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的转化医学

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100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的专利（医药）

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项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的文献（医药）

2025-04-01·Lancet Microbe

Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study

Article

作者: Mendy, Jason ; Liggett, Dani L ; Pierson, Benjamin C ; Ghosh, Neha ; Regules, Jason A ; Richardson, Jason S ; Warfield, Kelly L ; Gardner, Christina L ; Bedell, Lisa ; Burke, Crystal W ; Saunders, David ; Lee, Christine ; Hamer, Melinda J ; McCarty, James M ; Glass, Pamela J ; Haller, Jeannine M ; Royalty Tredo, Sarah ; Sanborn, Aaron D ; Gregory, Melissa K

BACKGROUND:

Immune responses to alphavirus vaccines might be impaired when heterologous alphavirus vaccines are administered sequentially. We aimed to compare immunogenicity and safety of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of heterologous alphavirus vaccines with alphavirus-naive controls in the USA.

METHODS:

In this open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled trial, which was conducted at two clinical study sites in the USA, adults (aged 18-65 years) who had previously received an investigational Venezuelan equine encephalitis virus vaccine (previous alphavirus vaccine recipients; n=30) and sex-matched and age-matched alphavirus vaccine-naive controls (n=30) were intramuscularly administered one 40 μg dose of CHIKV VLP vaccine on day 1. Immunogenicity was based on serum neutralising antibodies assessed by an in-vitro luciferase-based anti-CHIKV NT₈₀ neutralisation assay. The primary immunogenicity endpoint, which was assessed in the immunogenicity evaluable population (CHIKV VLP-vaccinated participants who had no important protocol deviations, had not received a prohibited medication, and provided evaluable serum sample results for baseline and on day 22), was to compare the proportion of previous alphavirus vaccine recipients with the proportion of alphavirus vaccine-naive controls who reached seroconversion 21 days after vaccination (ie, study day 22) with a single dose of CHIKV VLP vaccine, based on a four-fold increase of CHIKV neutralising antibodies compared with baseline. The significance of the comparison of the two groups was assessed using Fisher's exact test. The proportion with seroconversion in each group is presented with 95% CIs calculated using the Wilson method. The difference and 95% CIs for this difference was calculated based on Newcombe hybrid score method. An ANOVA model was fit with log₁₀-transformed titre as the dependent variable, and study arm, age, and sex as predictors. Least squares means, difference, and 95% CIs were back-transformed and reported as geometric mean titres (GMTs). This trial is registered with ClinicalTrials.gov, NCT03992872.

FINDINGS:

Between Nov 20, 2019, and Jan 19, 2021, 60 participants (20 [33%] female and 40 [67%] male; 40 (67%) White; median age 47·0 years [IQR 13·5]), 30 previous alphavirus vaccine recipients and 30 alphavirus vaccine-naive controls, were enrolled, vaccinated with CHIKV VLP, and completed the trial. The anti-CHIKV neutralising antibody seroconversion rate at day 22 was 100% (95% CI 88·6-100) in both groups. GMTs peaked in previous alphavirus vaccine recipients and alphavirus vaccine-naive controls at day 22 (2032·5 [95% CI 1413·0-2923·6] and 2299·2 [1598·1-3307·8], respectively) and were similar between the groups on day 22 and all subsequent visits. A higher proportion of previous alphavirus vaccine recipients (93·3% [95% CI 78·7-98·2]) had a four-fold neutralising antibody increase at day 8 than did alphavirus vaccine-naive controls (66·7% [48·8-80·8]; p=0·021). There was no statistically significant difference in the incidence of solicited adverse events between the previous alphavirus vaccine recipients and alphavirus vaccine-naive controls (53·3% vs 40·0%, respectively), although the relatively small sample size of the trial limited the power to detect a significant difference, and there were no reported vaccine-related serious adverse events.

INTERPRETATION:

CHIKV VLP vaccine was well tolerated and similarly immunogenic in both alphavirus vaccine-naive participants and previous recipients of a heterologous alphavirus vaccine. There were no significant differences in adverse events between the groups. The results of this study support the use of CHIKV VLP vaccine in individuals with previous alphavirus vaccine exposure.

FUNDING:

Defense Health Program, Emergent Travel Health, and Bavarian Nordic A/S.

2025-04-01·LANCET

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial

Article

作者: Warfield, Kelly L ; Jenkins, Victoria A ; Richardson, Jason S ; Tindale, Lauren C ; Muhammad, Sufia ; Bedell, Lisa ; Mendy, Jason ; Tredo, Sarah Royalty ; Loreth, Tobi ; Ajiboye, Patrick ; Ramanathan, Roshan ; Caso, Jorge T ; Anderson, Deborah M

BACKGROUND:

Chikungunya disease is a growing global public health concern. Vimkunya (previously chikungunya virus virus-like particle vaccine, previously PXVX0317) is a single-dose, pre-filled syringe for intramuscular injection. Here, we report safety, tolerability, and immunogenicity data for Vimkunya versus placebo in healthy adolescents and adults aged 12-64 years, and evaluate lot-to-lot consistency.

METHODS:

This pivotal phase 3, randomised, double-blind, placebo-controlled, parallel-group trial was done at 47 clinical trial sites in the USA. Eligible participants were healthy adolescents and adults aged 12-64 years. Participants were divided into three age strata (12-17 years, 18-45 years, and 46-64 years) within each site and randomly assigned (2:2:2:1) to receive one of three consecutively manufactured lots of Vimkunya or placebo (same excipient composition without chikungunya virus virus-like particle or aluminium hydroxide components) on study day 1. Neither participants, nor clinical site personnel, nor the funder knew participants' individual treatment assignments until all participants completed their involvement in the trial and the database was cleaned and locked. Participants attended a screening visit, followed by a day 1 visit that included random assignment, blood sample collection, and administration of a single dose of Vimkunya or placebo by intramuscular injection in the deltoid muscle. The coprimary endpoints were: the difference in chikungunya virus serum neutralising antibody seroreponse rate (vaccine minus placebo) at day 22; chikungunya virus serum neutralising antibody geometric mean titre (GMT) at day 22 for vaccine and placebo; and chikungunya virus serum neutralising GMT ratio at day 22 between all three pairs of vaccine lots (A:B, B:C, and A:C) in adults aged 18-45 years. The trial is registered with ClinicalTrials.gov, NCT05072080 and EudraCT, 2023-001124-42.

FINDINGS:

Between Sept 29, 2021, and Sept 23, 2022, 4215 participants were screened, of whom 3258 were eligible and enrolled (1667 [51·2%] female and 1591 [48·8%] male), and 3254 (99·9%) received either Vimkunya (n=2790) or placebo (n=464). The immunogenicity evaluable population included 2983 participants, of whom 2559 received Vimkunya and 424 received placebo. At day 22, 2503 (97·8%) of 2559 participants in the Vimkunya group had a seroresponse, compared with five (1·2%) of 424 participants in the placebo group for the immunogenicity evaluable population. The seroreponse rate difference was 96·6% (95% CI 95·0-97·5; p<0·0001). In the immunogenicity evaluable population, chikungunya virus serum neutralising antibody GMT at day 22 for the vaccine group was 1618 and for the placebo group was 7·9 (p<0·0001). At day 22, the serum neutralising GMT ratios for the pairs of lots (A:B, B:C, and A:C) were 0·98 (95% CI 0·85-1·14), 0·97 (0·84-1·12), and 0·95 (0·82-1·10), respectively. Vimkunya had a favourable safety profile; most adverse events were self-limiting and grade 1 or 2 in severity. The most common adverse events were injection site pain (656 [23·7%] of 2764 participants in the vaccine group), fatigue (551 [19·9%] of 2764), headache (498 [18·0%] of 2765), and myalgia (486 [17·6%] of 2764).

INTERPRETATION:

Vimkunya induces a rapid and robust immune response. These findings support the potential for this vaccine to protect individuals aged 12-64 years from disease caused by chikungunya virus.

FUNDING:

Emergent BioSolutions and Bavarian Nordic.

2025-04-01·LANCET

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial

Article

作者: Bedell, Lisa ; Ajiboye, Patrick ; Mendy, Jason ; Richardson, Jason S ; Ramanathan, Roshan ; Jenkins, Victoria A ; Muhammad, Sufia ; Tindale, Lauren C ; Anderson, Deborah M ; Tredo, Sarah Royalty ; Loreth, Tobi

BACKGROUND:

Adults older than 65 years are at increased risk for atypical presentations of chikungunya disease, as well as for severe outcomes including death.

METHODS:

In this phase 3, randomised, double-blind, placebo-controlled, parallel-group trial, adults aged 65 years and older received a single intramuscular dose of Vimkunya (previously chikungunya virus virus-like particle vaccine) or placebo at ten sites in the USA. Participants, clinical site personnel, and the sponsor were masked to individual treatment assignments until all participants had completed their involvement in the trial and the database was cleaned and locked. Baseline and postvaccination chikungunya virus serum neutralising antibody (SNA) titres (NT₈₀) were assessed at selected timepoints. Safety was assessed up to 183 days after dose administration in all participants from the exposed population who provided safety assessment data. This trial is registered with ClinicalTrials.gov, NCT05349617, and is completed.

FINDINGS:

Between May 12 and Dec 2, 2022, 413 participants were recruited and randomly assigned (1:1) to receive the Vimkunya vaccine (n=206) or placebo (n=207). The coprimary endpoints of immunologic superiority of chikungunya virus SNA titres compared with placebo and geometric mean titre at day 22 were met. Vimkunya induced a protective seroresponse (SNA NT₈₀≥100, considered the presumptive seroprotective antibody response) in 149 (82%) of 181 participants (95% CI 76·1-87·2) at day 15, in 165 (87%) of 189 participants (81·8-91·3) at day 22, and in 139 (76%) of 184 participants (68·9-81·2) at day 183. Although there was a slightly higher early immune response in the 65-74 years age group at day 15 compared with the 75 years and older age group, the seroresponse rates at day 22 and day 183 were similar. There were no notable differences in adverse event rates between groups, and most adverse events were grade 1 or 2 in severity and of short duration. No vaccine-related serious adverse events or deaths occurred.

INTERPRETATION:

We provide robust data from adults aged 65 years and older showing that Vimkunya is well tolerated and can provide a high rate of protection within 2 weeks postvaccination and during 6 months of follow-up.

FUNDING:

Emergent BioSolutions and Bavarian Nordic.

项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的新闻（医药）

2025-05-07

·GlobeNewswire-Health Care

Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom

May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. Bavarian Nordic is targeting launch of the vaccine in the UK during the summer of 2025. “Chikungunya mostly represents a risk for UK citizens traveling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change1,” said Paul Chaplin, President and CEO of Bavarian Nordic. “The mosquitos cannot be stopped, but with preventative measures such as vaccines, we can mitigate the impact of emerging diseases like chikungunya for those at risk, and we look forward to launching our vaccine in the UK later this year.” The UK approval of VIMKUNYA marks the third approval of Bavarian Nordic’s chikungunya vaccine, which was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025.2,3 Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026. Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years4. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years5. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide6. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile7. VIMKUNYA is a single dose, prefilled, adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. 1 European Centre for Disease Prevention and Control. Increasing risk of mosquito-borne diseases in EU/EEA following spread of Aedes species. https://www.ecdc.europa.eu/en/news-events/increasing-risk-mosquito-borne-diseases-eueea-following-spread-aedes-species 2 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. https://www.bavarian-nordic.com/media/media/news.aspx?news=7053 3 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. https://www.bavarian-nordic.com/media/media/news.aspx?news=7056 4 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. https://www.cdc.gov/chikungunya/data-maps/index.html. 5 European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease. 6 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. https://www.ecdc.europa.eu/en/publications-data/chikungunya-virus-disease-case-notification-rate-100-000-population-january-2024. 7 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准疫苗

2025-05-06

·蒲公英Ouryao

一周｜国际法规药事(04.28-05.04)

◆ ◆ ◆ ◆Paul's Insight2025年4月28日-5月4日◆ ◆ ◆ ◆过去一周（4月28日至5月4日），全球制药监管与行业机构发布了多项重要动态。美国FDA在细胞产品安全和质量管理等领域持续发力；欧盟EMA在临床前新方法学新药审批上有新的更新；欧洲药典EDQM进一步完善CEP电子提交流程；英国MHRA在疫苗审批、给药创新和执法行动上齐头并进；美国PDA重启区域分会，并探讨前沿疫苗传递技术；ISPE则描绘了生物制造设施与数字化转型的未来蓝图。美国FDA细胞产品安全和质量/GMP两大领域持续发力1. 人源细胞组织产品安全管理新指南草案5月2日，美国FDA的生物制品评估与研究中心（CBER）发布两份针对人源细胞、组织及衍生产品（HCT/P）的指南草案。一是《减少HCT/P相关脓毒症病原体传播风险的建议》，更新了2007年供体资格决策中脓毒症筛查与检测标准；二是《减少HCT/P中结核分枝杆菌传播风险的建议》，在专用检测工具面世前，明确了结核病史与风险因素评估的推荐措施。两份草案现正面向公众征询意见，反馈截止日期为7月7日。图：美国FDA发布两份针对人源细胞、组织及衍生产品（HCT/P）的指南草案https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-reduce-risk-transmission-disease-agents-associated-sepsis-human-cells-tissues-and2. 质量管理成熟度原型评估计划FDA药品评估与研究中心（CDER）宣布，将启动自愿质量管理成熟度（QMM）原型评估计划的第二轮工作。该计划面向符合条件的药品生产企业开放申请，申请者需具备已完成注册、具备检查记录，并在美国市场有商业化分销产品等资格。入选企业将接受由三名CDER工作人员组成的QMM评估团队的系统性评估，评估不涉及负责cGMP合规的FDA检查人员。为期五天的评估将围绕企业的质量管理实践进行，企业将提前收到评估议程，并需安排适当人员参与。评估结束后，企业将收到一份详尽的评估报告，内容包括各实践领域的评分、说明、优势亮点及改进建议，并有机会与评估团队面对面沟通报告内容、提出问题或反馈意见。图：FDA启动质量管理成熟度原型评估计划第二轮工作https://www.federalregister.gov/documents/2025/04/23/2025-06968/voluntary-quality-management-maturity-prototype-assessment-protocol-evaluation-program3. 电商平台执法力度再升级4月29日，FDA向电商巨头亚马逊发出警告信，指控其平台销售未经FDA批准的新药，包括多款声称用于纹身前后镇痛的外用制剂。FDA通过亚马逊网站采购样品后确认，相关产品均未获FDA许可且标签不合规，构成对《联邦食品、药品和化妆品法案》第301条的违反。此次行动彰显FDA对线上销售渠道监管的持续加码。图：FDA向电商巨头亚马逊发出警告信https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-689355-041720254. 泛疫苗（广谱疫苗）新体系——“金标准”项目5月1日，美国卫生部（HHS）和国立卫生研究院（NIH）联合宣布启动“金标准”（Generation Gold Standard）泛疫苗开发项目，计划投入约5亿美元，研发可同时对抗多种流感和冠状病毒株的广谱疫苗。项目将采用β-丙内酯灭活全病毒技术，目前已在实验室中制备了针对H5N1与多种冠状病毒的候选疫苗。图：美国官方宣布开发泛疫苗（广谱疫苗）新体系https://www.hhs.gov/press-room/hhs-nih-announces-generation-gold-standard.html美国PDA分会动态与疫苗给药创新1. 波多黎各分会重新启动5月2日，PDA发表文章宣布重启波多黎各分会，新任负责人Myrta Atiles将聚焦AI等新兴技术应用，推动区域人才培养与技术创新。2月25日于波多黎各举办的“加速创新，快速惠及患者”会议，探讨了无菌加工、技术转移敏捷性及监管加速等话题。波多黎各是全球重要的制药制造中心之一，拥有高度集中的制药和生物制药产业，对该地区经济具有支柱性作用。图：PDA宣布波多黎各分会重新启动https://www.pda.org/pda-letter-portal/home/full-article/pda-puerto-rico-chapter-reignites2. 微针阵列贴片（MAP）疫苗给药创新4月29日，PDA发布文章聚焦微针阵列贴片（MAP）这一新兴疫苗传递技术。MAP通过不足一毫米的微针将疫苗递送至皮肤表层，激活免疫反应，具备减少剂量、简化冷链物流、提高接种率等优势。其材料多为可溶性或可降解聚合物，具备良好生物相容性。临床研究显示，MAP在安全性和免疫效果上表现优异，尤其适用于资源有限地区。尽管仍面临生产、监管等挑战，MAP有望成为未来全球疫苗接种的重要工具。图：PDA探讨疫苗给药创新https://www.pda.org/pda-letter-portal/home/full-article/microneedle-array-patches-for-vaccine-delivery欧盟EMA临床前研究新方法学与新药审批1. 推动新方法学（NAM）替代动物试验欧洲药品管理局（EMA）表示，其正积极推动在药物研发和测试中采用新的方法学（NAM），以减少动物使用，践行“3R”原则（替代、减少、优化）。这些新技术包括器官芯片、类器官、体外细胞模型和计算机建模，旨在在确保药物安全有效的同时，提高科学预测性并减少伦理争议。EMA通过其创新工作组（ITF）为开发者提供免费咨询平台，帮助新方法更顺利地被纳入监管体系。图：EMA推动新方法学替代动物试验https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing/regulatory-acceptance-new-approach-methodologies-nams-reduce-animal-use-testing2. 对Winlevi（clascoterone）给出负面意见4月25日，EMA人用药品委员会（CHMP）对意大利Cassiopea公司申请的痤疮治疗药Winlevi（clascoterone）提出负面意见，认为其在12至18岁青少年中的潜在风险大于获益。Winlevi作为一种新型雄激素受体阻断药，虽以乳膏形式用于治疗寻常痤疮，但可能抑制下丘脑、垂体及肾上腺功能，影响青少年的生长发育与性成熟。尽管企业提交的数据显示风险较低，并提出相应的风险控制措施，CHMP仍认为证据不足，最终建议拒绝其上市许可申请。图：EMA对痤疮治疗药的评审提出负面意见https://www.ema.europa.eu/en/medicines/human/EPAR/winlevi欧洲EDQMCEP电子化提交流程再升级5月2日，EDQM宣布，将接受基于eCTD验证标准v8.1的CEP申请，同时在2025年5月31日前继续兼容v7.1版本，以确保提交过程平稳过渡。此举旨在应对当前EU M1包中跟踪表位置要求与EDQM实际流程不一致的问题。图：CEP电子化提交流程再升级https://www.edqm.eu/en/w/validation-of-ectd-submissions-for-cep-applications英国MHRA新药审评与打击非法药品行动1. Vimkunya基孔肯雅疫苗获批5月1日，英国药品和健康产品监管局（MHRA）通过国际认可程序（IRP）批准Vimkunya疫苗，用于预防12岁及以上人群感染基孔肯雅病毒。基孔肯雅病由受感染蚊子传播，常见于亚洲、非洲及美洲的亚热带地区，患者通常出现发热、皮疹及关节剧烈疼痛，症状可能持续数月甚至数年。Vimkunya疫苗的批准基于IRP机制，该机制允许MHRA借鉴国际可信监管机构的专业评估，以加快英国患者的用药可及性。MHRA在IRP框架下仍保留对证据强度不足的申请予以拒绝的权力。图：MHRA通过国际认可程序（IRP）批准疫苗https://www.gov.uk/government/news/vimkunya-vaccine-approved-to-prevent-disease-caused-by-the-chikungunya-virus-in-people-12-years-of-age-and-older2. 纳武利尤单抗皮下注射新给药方案批准4月30日，英国MHRA批准纳武利尤单抗（nivolumab，商品名Opdivo）皮下注射新配方，将给药时间从传统的30–60分钟静脉输注大幅缩短至仅需3–5分钟，适用于包括肺癌、黑色素瘤等多种肿瘤类型，显著提升患者治疗舒适度与临床操作效率。该药由百时美施贵宝（BMS）研发，是一款程序性死亡受体-1（PD-1）抑制剂，可通过激活免疫系统识别并攻击肿瘤细胞。图：纳武利尤单抗皮下注射给药方案批准https://www.gov.uk/government/news/mhra-authorises-cancer-treatment-variation-with-an-administration-time-of-3-5-minutes3. 打击非法药品4月29日凌晨，英国MHRA在英格兰中西部及西北部发起大规模突袭行动，逮捕了12名涉嫌组织药品贩运的犯罪嫌疑人。这也是MHRA历史上规模最大的一次此类刑事调查。执法人员在现场查获了大量非法药物和犯罪资产：数十万剂包括类鸦片镇痛药和抗焦虑药在内的受控药物被缴获。图：英国MHRA打击非法药品行动https://www.gov.uk/government/news/twelve-arrested-in-mhras-biggest-ever-crackdown-on-organised-medicines-trafficking国际ISPE上周，ISPE发布了两篇预告文章，介绍2025年ISPE生物技术大会将重点讨论的两大主题：1. 生物制造设施的未来格局在“设施生命周期”专场中，行业专家将探讨如何从传统的静态基础设施，转型为灵活、自适应的生产生态系统，以应对多样化治疗模式对速度、可持续性和敏捷制造的需求。重点议题包括：武田制药展示的实时产能建模、模块化建设与数字化集成实践，以及如何通过应用ISO 14644-16等国际标准，实现洁净室的节能设计和运营效率最大化。2. 人工智能/机器学习与生物技术融合趋势在“利用人工智能和机器学习(AI/ML) 加速生物制药发展”专场，专家们将分享AI/ML在药物研发、临床试验优化、智能制造及供应链管理中的应用实例，展示其如何加速产品上市并提升运营效率。讨论内容包括支持AI部署的数据架构建设、AI驱动的持续工艺确认（CPV）与实时放行（RTR）、mRNA项目中的可解释性建模，以及通过强化学习实现自主运营与技能传承的前沿探索。图：ISPE发布了预告文章，介绍2025年ISPE生物技术大会将重点讨论的主题https://ispe.org/pharmaceutical-engineering/ispeak/trends-and-opportunities-how-artificial-intelligence-ai-and结语回顾一周动态，各大监管机构和行业组织在药品安全、监管创新、技术应用和执法合规等方面均有进展。FDA聚焦细胞治疗与质量管理、EMA强调替代动物试验与风险评估、EDQM优化电子提交流程、MHRA加速疫苗与给药方案审批并加强执法、PDA与ISPE则在疫苗传递与生物制造数字化等方面绘制蓝图。这些举措体现了全球制药监管与行业在科学进步、伦理责任和患者需求三者之间的协调与平衡，共同推动药品研发和监管迈向更加智能、高效和安全的未来。END声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。活动推荐5月8日 | 线上 | 双维度解锁无菌药品生产污染防控策略5月16日 | 线上 |《VHP生物指示剂的应用》5月22日 | 线下 | 2025中国无菌药品制造创新发展论坛

疫苗基因疗法加速审批

2025-05-02

·Pharmaceutical Technology

MHRA authorises Bavarian Nordic’s chikungunya virus vaccine

Bavarian Nordic’s chikungunya vaccine application has been submitted for approval to Health Canada. Credit: Sonia Bonet/Shutterstock. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Bavarian Nordic’s Vimkunya (recombinant, adsorbed) vaccine for preventing chikungunya virus infection in people aged 12 and above. Vimkunya also received approvals from the US Food and Drug Administration (FDA) and the European Commission (EC). The vaccine’s authorisation in the UK was facilitated by the international recognition procedure, acknowledging the recent EC approval. Vimkunya’s launch in the country is anticipated by the summer of 2025. Bavarian Nordic’s chikungunya vaccine application has been submitted for approval to Health Canada, with potential authorisation expected in the first half of 2026. Designed as a prefilled, single-dose, adjuvanted virus-like particle recombinant protein vaccine, Vimkunya is approved for active immunisation to prevent the virus in these individuals. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Approvals in the UK, EU and US were supported by the outcomes from two Phase III trials. These trials, which involved 3,500 healthy participants, met their primary endpoints, demonstrating the vaccine’s performance in inducing neutralising antibodies in up to 97.8% of the vaccinated subjects, within 21 days post-vaccination. Vimkunya was found to be tolerated well, with the most common side effects being injection site pain, headache, muscle pain and fatigue, mostly mild or moderate. Bavarian Nordic CEO and president Paul Chaplin stated: “Chikungunya mostly represents a risk for UK citizens travelling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change.” In December 2024, the company entered a licence and manufacturing agreement with the Serum Institute of India for its mpox vaccine, MVA-BN.

上市批准临床结果临床3期引进/卖出疫苗

100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
基孔肯雅热	美国	Bavarian Nordic A/S	2025-02-14

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临床结果

适应症

分期

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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


NCT05349617 (FDA_CBER) 人工标引	临床3期	基孔肯雅热	-	VIMKUNYA	衊鬱糧積餘遞齋鹽鬱觸(齋夢繭鹽壓構糧淵繭夢) = 鹽獵構艱蓋獵壓製獵廠遞築鏇鹹願齋憲鹹願範 (夢鏇觸醖觸顧艱醖鹽築, 582.3 ~ 892.7) 更多	积极	2025-02-14
				Placebo	衊鬱糧積餘遞齋鹽鬱觸(齋夢繭鹽壓構糧淵繭夢) = 鹹觸壓鹹積憲構獵築範遞築鏇鹹願齋憲鹹願範 (夢鏇觸醖觸顧艱醖鹽築, 6.5 ~ 10.0) 更多
NCT05072080 (FDA_CBER) 人工标引	临床3期	基孔肯雅热	-	VIMKUNYA	膚衊廠窪艱構鏇齋觸獵(衊構餘簾壓醖醖襯積遞) = 憲餘醖艱廠壓衊憲範積顧鑰壓顧繭鑰範膚壓積 (鹹鬱鹽構選範鹹獵獵淵, 1504.1 ~ 1695.6) 更多	积极	2025-02-14
				Placebo	膚衊廠窪艱構鏇齋觸獵(衊構餘簾壓醖醖襯積遞) = 襯壓憲鹹糧繭積繭繭醖顧鑰壓顧繭鑰範膚壓積 (鹹鬱鹽構選範鹹獵獵淵, 7.0 ~ 8.8) 更多
NCT05349617 (CTgov)	临床3期	-	413	CHIKV VLP/adjuvant (Group 1 - PXVX0317)	艱簾觸顧鏇蓋構衊繭艱 = 獵衊艱積顧艱壓醖網艱夢鏇窪襯範廠鹹齋觸壓 (廠艱鏇鹽夢簾鹽選願顧, 壓淵憲鑰顧憲鏇鏇顧積 ~ 醖簾觸簾選鏇廠鬱餘膚) 更多	-	2024-12-13
				Placebo (Group 2 - Placebo)	艱簾觸顧鏇蓋構衊繭艱 = 膚餘襯夢夢簾觸糧糧顧夢鏇窪襯範廠鹹齋觸壓 (廠艱鏇鹽夢簾鹽選願顧, 壓網壓夢繭遞醖糧構鹽 ~ 觸鬱構築醖鹽獵願積簾) 更多
NCT05072080 (CTgov)	临床3期	基孔肯雅热	3,258	CHIKV VLP/adjuvant (Group 1)	遞醖遞蓋窪齋觸觸構衊 = 築製構構餘蓋鏇願遞鏇淵鏇衊鬱築獵齋構糧憲 (鹹窪鬱築窪簾構遞廠遞, 窪淵襯遞觸網壓窪範積 ~ 壓壓願簾獵繭憲憲艱窪) 更多	-	2024-08-30
				CHIKV VLP/adjuvant (Group 2)	遞醖遞蓋窪齋觸觸構衊 = 鹹觸窪憲製淵遞膚廠窪淵鏇衊鬱築獵齋構糧憲 (鹹窪鬱築窪簾構遞廠遞, 範鏇鏇顧積築構鏇顧齋 ~ 構憲襯鬱遞鏇願鏇鑰獵) 更多
NCT02562482 (phase 2, Pubmed \| Vaccine)	临床2期	基孔肯雅热 focus reduction neutralizing antibody	400	CHIKV VLP vaccine seropositive recipients	鹹築鬱壓衊醖範觸夢襯(艱鹽選蓋範構廠蓋獵艱) = 製遞鏇鹽製蓋繭窪遞廠簾積齋膚顧網築餘壓鬱 (觸膚積壓壓願鹽範繭艱 )	积极	2023-10-06
				CHIKV VLP vaccine seronegative recipients	鹹築鬱壓衊醖範觸夢襯(艱鹽選蓋範構廠蓋獵艱) = 淵齋遞選鹽鏇範鏇簾鏇簾積齋膚顧網築餘壓鬱 (觸膚積壓壓願鹽範繭艱 )
NCT05065983 (CHIKV VLP, CTgov)	临床2期	基孔肯雅热	25	CHIKV VLP, adjuvanted	鹽壓鏇膚簾網獵憲願廠 = 廠鹽夢糧積簾遞淵鏇醖鏇鬱壓憲膚夢齋淵鏇選 (廠願遞醖壓獵構築糧夢, 築膚壓窪遞選製壓醖餘 ~ 選膚夢壓艱壓壓觸範構) 更多	-	2023-02-28
NCT03992872 (WRAIR, Biospace) 人工标引	临床2期	甲病毒感染 \| 基孔肯雅热	60	PXVX 0317	鹽襯鏇選選鹹夢壓簾簾(壓廠獵製簾顧壓製鏇鏇) = The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. 廠艱鏇構艱蓋繭鑰網窪 (淵膚夢齋醖糧獵鬱積鏇 )	积极	2022-11-01
NCT02562482 (Pubmed \| J Coll Physicians Surg Pak) 人工标引	临床2期	基孔肯雅热	400	PXVX-0317	襯襯範遞糧鏇築繭顧鏇(淵糧製憲獵淵構簾鏇遞) = 醖衊顧糧餘遞衊廠願鏇壓鏇願餘鹽繭顧築艱構 (網遞糧繭範憲襯觸淵願 ) 更多	积极	2020-04-14
				Placebo	襯襯範遞糧鏇築繭顧鏇(淵糧製憲獵淵構簾鏇遞) = 蓋選網築憲夢糧鑰艱糧壓鏇願餘鹽繭顧築艱構 (網遞糧繭範憲襯觸淵願 ) 更多
NCT02562482 (VRC-CHKVLP059-00-VP \| phase 2, CTgov)	临床2期	基孔肯雅热	400	VRC-CHKVLP059-00-VP (Group 1: VRC-CHKVLP059-00-VP 20 mcg)	繭壓壓憲衊壓鹽糧鑰窪 = 遞獵壓鏇艱鏇鹽壓鏇遞憲顧夢獵廠壓獵簾醖醖 (衊鬱窪襯壓製鹽選衊廠, 齋淵鬱顧遞獵餘壓夢鏇 ~ 獵餘廠簾鑰製醖蓋獵鹹) 更多	-	2019-05-14
				VRC-PBSPLA043-00-VP (Group 2: Placebo (VRC-PBSPLA043-00-VP))	繭壓壓憲衊壓鹽糧鑰窪 = 壓襯醖餘餘廠衊糧齋衊憲顧夢獵廠壓獵簾醖醖 (衊鬱窪襯壓製鹽選衊廠, 壓網壓衊衊選鑰膚鹹簾 ~ 壓蓋獵鹽選壓壓壓糧窪) 更多
NCT03483961 (PipelineReview) 人工标引	临床2期	基孔肯雅热	415	PXVX-0317	憲淵顧壓鏇壓願鏇夢鏇(衊簾艱構夢艱廠繭獵膚) = 餘顧願蓋艱鹽膚繭鬱衊夢積願夢夢憲顧簾衊廠 (簾壓壓夢鏇選襯襯窪鏇 ) 更多	积极	2019-04-17