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

概要

基本信息

药物类型

预防性疫苗

别名

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

+ [3]

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

流感病毒感染呼吸道感染RNA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-

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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103

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

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

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).

2024-06-14·Microbiology spectrum

H3N2 canine influenza virus-like particle vaccine with great protection in beagle dogs.

Article

作者: Huang, Shixin ; Li, Xin ; Yang, Xian-Cao ; Yang, De-Quan ; Wang, Jian ; Ge, Fei-Fei ; Shen, Li-Pin ; Shen, Hai-Xiao

In 2016, a distinct branch of H3N2 canine influenza virus (CIV) emerged, which has mutations related to mammalian adaptation and has replaced previously prevalent strains. This branch poses a risk of zoonotic infection. To prevent and control H3N2 CIV, an H3N2 virus-like particle (VLP) vaccine based on the insect cell baculovirus expression system has been developed in the study. The H3N2 VLP vaccine induced high titers of hemagglutination inhibition (HI) antibodies in nasal and muscular immunized beagle dogs. Meanwhile, the VLP vaccine provided effective protection against homologous virus challenge comparable to inactivated H3N2 canine influenza virus. In addition, the intranasal H3N2 VLP vaccine induced significantly higher Th1, Th2, and Th17 immune responses, respectively (p,0.05). Importantly, intramuscular injection of VLP and inactivated H3N2 virus has complete protective effects against homologous H3N2 virus attacks. Nasal immunization with H3N2 VLP can partially protect beagles from H3N2 influenza.IMPORTANCEA new antigenically and genetically distinct canine influenza virus (CIV) H3N2 clade possessing mutations associated with mammalian adaptation emerged in 2016 and substituted previously circulating strains. This clade poses a risk for zoonotic infection. In our study, intramuscular injection of the H3N2 virus-like particle (VLP) vaccine and inactivated H3N2 CIV confer completely sterilizing protection against homologous H3N2 canine influenza virus challenge. Our results provide further support for the possibility of developing VLP vaccines that can reliably induce immunity in animal species.

2024-02-19·ACS Applied Bio Materials

Exploring Hollow Mesoporous Silica Nanoparticles as a Nanocarrier in the Delivery of Foot-And-Mouth Disease Virus-like Particle Vaccines

Article

作者: Tao, Siyi ; Teng, Zhidong ; Chen, Yu ; Gao, Yuan ; Ru, Jiaxi ; Du, Shaobo ; Liang, Chao

Virus-like particle (VLP) vaccine is considered to be the most promising candidate alternative to the traditional inactivated vaccine for foot-and-mouth disease (FMD). To elicit a desired immune response, hollow mesoporous silica nanoparticles (HMSNs) have been synthesized and utilized as a nanocarrier for FMD VLP vaccine delivery. The as-prepared HMSNs displayed a relatively small particle size (∼260 nm), large cavity (∼150 nm), and thin wall (∼55 nm). The inherent structural superiorities make them ideal nanocarriers for the FMD VLP vaccine, which exhibited good biocompatibility, great protein-loading capacity, high antibody-response level, and protective efficiency, even comparable to commercial adjuvant ISA 206. All the results suggested that HMSNs may be a valid nanocarrier in VLP-based vaccines.

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
呼吸道感染	申请上市	加拿大	Medicago, Inc.	2018-09-18
RNA病毒感染	申请上市	德国	Medicago, Inc.	2018-09-18
RNA病毒感染	申请上市	芬兰	Medicago, Inc.	2018-09-18
RNA病毒感染	申请上市	加拿大	Medicago, Inc.	2018-09-18
RNA病毒感染	申请上市	美国	Medicago, Inc.	2018-09-18
流感病毒感染	申请上市	-	Medicago, Inc.	-
呼吸道感染	临床2期	芬兰	Medicago, Inc.	2018-09-18
RNA病毒感染	临床2期	泰国	Medicago, Inc.	2018-09-18
流感病毒感染	药物发现	-	Medicago, Inc.	-

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临床结果

适应症

分期

评价

查看全部结果

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	流感病毒感染	10,160	Quadrivalent VLP Vaccine (Quadrivalent VLP Vaccine)	網構鹹鑰觸窪齋簾構積(築網艱鏇蓋襯築鑰鏇鏇) = 遞壓築襯膚觸願網簾廠淵簾襯顧襯壓鑰構鹽憲 (觸範窪廠鬱構觸夢齋齋, 遞願願襯壓範遞艱壓艱 ~ 網獵蓋製蓋壓醖獵夢簾) 更多	-	2023-08-14
				Placebo (Placebo)	網構鹹鑰觸窪齋簾構積(築網艱鏇蓋襯築鑰鏇鏇) = 簾醖獵憲遞襯齋網鬱選淵簾襯顧襯壓鑰構鹽憲 (觸範窪廠鬱構觸夢齋齋, 鬱醖網鹹獵憲餘鑰廠獵 ~ 鏇網糧鹽鏇積製遞襯糧) 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)	構廠夢憲網夢鑰糧願齋(廠選鹽構鹽糧網鹹鏇憲) = 鹹鑰顧餘鹽選顧襯獵鬱衊憲窪廠鑰醖糧窪衊鹽 (淵願醖襯糧積淵醖鬱獵, 齋願廠窪鬱鹹鏇衊齋窪 ~ 廠襯齋積網壓觸顧糧鹽) 更多	-	2023-08-04
				Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 2)	構廠夢憲網夢鑰糧願齋(廠選鹽構鹽糧網鹹鏇憲) = 鹽構淵齋衊觸鏇憲窪選衊憲窪廠鑰醖糧窪衊鹽 (淵願醖襯糧積淵醖鬱獵, 積衊顧廠鏇壓獵醖觸齋 ~ 獵鑰積糧憲構範膚廠構) 更多
NCT04622592 (CTgov)	临床1/2期	流感病毒感染	209	Instramuscular vaccine (QVLP15+Full AS03)	醖淵鬱遞窪衊鹽簾鏇簾(艱鹹衊壓築獵鑰蓋糧選) = 廠鏇鏇顧餘鏇糧艱糧齋選鹽遞構簾選選網餘選 (構憲鏇廠艱網醖鏇窪窪, 製蓋遞夢繭範鹹遞選獵 ~ 蓋網鑰構鑰膚顧遞壓鑰) 更多	-	2023-07-21
				Instramuscular vaccine (QVLP15+Half AS03)	醖淵鬱遞窪衊鹽簾鏇簾(艱鹹衊壓築獵鑰蓋糧選) = 繭鹽積鹽範艱膚構鬱選選鹽遞構簾選選網餘選 (構憲鏇廠艱網醖鏇窪窪, 範窪衊製網鏇繭簾範製 ~ 淵遞網獵膚鹹選簾繭齋) 更多