Seasonal quadrivalent influenza vaccine(Medicago, Inc.)(Seasonal quadrivalent influenza vaccine(Medicago, Inc.))

概要

基本信息

药物类型

病毒样颗粒疫苗、预防性疫苗、多价疫苗

别名

Influenza virus vaccine quadrivalent、Quadrivalent seasonal influenza VLP vaccine、Seasonal influenza vaccine quadrivalent

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靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

流感病毒感染

原研机构

Medicago, Inc.

在研机构-

非在研机构

Medicago, Inc.

最高研发阶段终止申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

6

项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的临床试验

NCT04622592

/ Completed临床1/2期

A Randomized, Partially-Blinded, Active Comparator-Controlled, Dose-Ranging, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of an Adjuvanted Seasonal Recombinant Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains.
In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development.
Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).

开始日期2020-11-02

申办/合作机构

Medicago, Inc.

NCT03739112

/ Completed临床3期

A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

开始日期2018-09-18

申办/合作机构

Medicago, Inc.

NCT03321968

/ Completed临床3期

A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

开始日期2017-09-29

申办/合作机构

Medicago, Inc.

100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的临床结果

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100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的转化医学

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100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的专利（医药）

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108

项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of a bivalent norovirus vaccine candidate in infants from 6 weeks to 5 months of age: A phase 2, randomized, double-blind trial

Article

作者: López, Pío ; Mendelman, Paul M ; Baehner, Frank ; Borkowski, Astrid ; Sáez-Llorens, Xavier ; Sherwood, Jim ; deAntonio, Rodrigo ; Masuda, Taisei ; López-Medina, Eduardo

As infants suffer significant morbidity and mortality due to norovirus-related acute gastroenteritis (AGE), we assessed four formulations of the bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in Panamanian and Colombian infants. 360 infants aged 6 weeks to 5 months were randomly allocated to 8 groups to receive three doses of HIL-214 or two doses of HIL-214 and one dose of placebo (Days 1, 56 and 112), where HIL-214 doses contained 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH)₃. Solicited injection-site and systemic adverse events (AE) were collected within 7 days after each dose, unsolicited AEs were collected within 28 days after each, and serious AEs throughout the study. Pan-Ig and histoblood group antigen-blocking antibodies (HBGA) were measured on Days 1, 56, 84, and 140. All formulations were well-tolerated causing mainly mild-to-moderate transient solicited AEs, most frequently local pain and irritability/fussiness, but no vaccine-related serious AEs. Two doses of each formulation induced high titers of high avidity Pan-Ig and also HBGA antibodies; a third dose increased titers against both antigens and the avidity of Pan-Ig antibodies against GII.4c but not against GI.1. Two and three doses of HIL-214 were well-tolerated and induced potent immune responses at 4-6 months of age supporting further clinical assessment to protect against norovirus-related AGE.

2025-01-01·International Journal of Biological Macromolecules

Investigating the stability of chimeric murine polyomavirus VP1 Capsomeres via molecular dynamics simulations and experimental analysis

Article

作者: Zhang, Songping ; Luo, Hong ; Ma, Yanyan ; Gerstweiler, Lukas ; Gu, Yanhao ; Su, Zhiguo

The development of modular virus-like particle (VLP) vaccine platforms with genetically inserted antigens in viral structural proteins shows great promise for advancing vaccine technology. However, the instability of many constructs leads to trial-and-error approaches, and the challenge of predicting stability based solely on amino acid sequences remains unresolved, yet highly appealing. This study evaluates the stability of wild-type murine polyomavirus (MPV) VP1 capsomeres and three engineered chimeric variants using molecular dynamics (MD) simulations and laboratory experiments. MD simulations, based on AlphaFold2 predictions and up-to-date all-atom force fields, accurately predicted the thermal stability and hydrophobicity of VP1-based capsomeres. Thermodynamic analysis revealed that binding energies from simulations reliably indicate thermal stability. Experiments and simulation results showed that inserts influence the stability of capsomeres differently, with larger insertions generally having a greater impact on the structures of capsomeres. This leads to increased intra-subunit distances and a higher proportion of flexible regions in the capsomere chassis. Capsomeres with less compact structures were found to have lower thermal stability. Specifically, the thermal transitional temperature (T_m) of the wild-type capsomeres was 46.9 °C, while the T_m values of the three chimeric derivatives were 42.0 °C, 38.8 °C, and 37.7 °C, reflecting a correlation between decreased thermal stability and reduced structural compactness. This research presents a robust approach for predicting the stability of novel VLP constructs based on amino acid sequences, potentially enhancing vaccine design by reducing failures, and suggests a shift towards minimal epitope insertions for improved stability.

2024-12-31·Human Vaccines & Immunotherapeutics

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Article

作者: Kuxhausen, Adrienne ; Naficy, Abdi ; Mwakingwe-Omari, Agnes ; Seifert, Harry ; Hastie, Andrew ; Leav, Brett ; Anteyi, Kate ; Miller, Jacqueline

The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

100 项与 Seasonal quadrivalent influenza vaccine(Medicago, Inc.) 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
流感病毒感染	临床1期	-	Medicago, Inc.	-
流感病毒感染	临床1期	-	Medicago, Inc.	-

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临床结果

适应症

分期

评价

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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


NCT03301051 (CTgov)	临床3期	RNA病毒感染 \| 呼吸系统疾病 \| 流感病毒感染 \| 呼吸道感染 \| 病毒感染	10,160	Quadrivalent VLP Vaccine (Quadrivalent VLP Vaccine)	遞淵顧鬱糧齋構壓憲鹽(願簾鏇襯襯繭艱艱蓋選) = 衊鏇壓遞壓憲糧餘淵築鬱廠願壓餘鬱願窪獵夢 (蓋窪衊廠壓餘遞網構窪, 齋壓構糧膚廠廠鑰願艱 ~ 鑰鏇憲糧構選壓遞憲願) 更多	-	2023-08-14
				Placebo (Placebo)	遞淵顧鬱糧齋構壓憲鹽(願簾鏇襯襯繭艱艱蓋選) = 襯憲糧淵繭窪憲齋夢鑰鬱廠願壓餘鬱願窪獵夢 (蓋窪衊廠壓餘遞網構窪, 願襯築繭憲遞鹽獵鏇鹹 ~ 鹽鏇願積壓選鏇艱醖糧) 更多
NCT03321968 (CTgov)	临床3期	流感病毒感染	1,202	Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 1)	鬱築蓋淵觸艱醖餘艱觸(顧衊繭糧鏇鹹積製鹹網) = 範鹹壓齋夢窪簾積簾鑰願構鑰蓋膚艱積衊蓋窪 (壓壓構夢齋齋鏇夢醖獵, 鑰鑰艱遞網獵衊鬱蓋廠 ~ 觸窪繭膚醖鹹蓋製艱簾) 更多	-	2023-08-04
				Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 2)	鬱築蓋淵觸艱醖餘艱觸(顧衊繭糧鏇鹹積製鹹網) = 膚簾廠鹹蓋廠獵醖鹹願願構鑰蓋膚艱積衊蓋窪 (壓壓構夢齋齋鏇夢醖獵, 齋繭淵積廠鹽艱遞餘顧 ~ 鏇廠鑰壓鬱範獵築鑰鹹) 更多
NCT04622592 (CTgov)	临床1/2期	流感病毒感染	209	Instramuscular vaccine (QVLP15+Full AS03)	鏇憲遞齋鑰醖夢築壓艱(鬱鹹鏇顧襯築窪餘網窪) = 顧鏇鑰齋顧網鬱窪膚蓋鹹齋餘鑰淵艱夢繭築構 (繭廠遞膚憲艱糧選範憲, 醖願鹹壓壓簾醖獵鬱觸 ~ 獵衊窪糧簾遞鑰願鹽淵) 更多	-	2023-07-21
				Instramuscular vaccine (QVLP15+Half AS03)	鏇憲遞齋鑰醖夢築壓艱(鬱鹹鏇顧襯築窪餘網窪) = 觸窪願鹽廠鹹簾製憲鏇鹹齋餘鑰淵艱夢繭築構 (繭廠遞膚憲艱糧選範憲, 簾鬱遞鹽窪鹹餘齋醖餘 ~ 蓋製襯獵膚繭獵觸夢膚) 更多