A Phase II, Multicenter, Randomized, Double-Blind, Active Comparator Controlled Study of the Immunogenicity and Safety of VAX2012Q, A Quadrivalent Influenza Vaccine in Healthy Adults 18-64 Years

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.

开始日期2015-05-01

申办/合作机构

VaxInnate Corp.

[+2]

NCT02247362 / Unknown status临床1/2期

Phase 1b/2 Double Blind, Randomized, Placebo Controlled Study of Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years

One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled study.

开始日期2014-11-01

申办/合作机构

VaxInnate Corp.

NCT02015494 / Unknown status临床1期

Phase 1 Study of the Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 18-40 Years

One dose of escalating strengths of an investigational influenza vaccine VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for tolerability and immunogenicity in healthy adults 18-40 years of age.

开始日期2014-03-01

申办/合作机构

VaxInnate Corp.

100 项与 VAX-2012Q 相关的临床结果

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100 项与 VAX-2012Q 相关的转化医学

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100 项与 VAX-2012Q 相关的专利（医药）

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项与 VAX-2012Q 相关的文献（医药）

2016-01-01·Open Forum Infectious Diseases3区 · 医学

Phase 1 Safety and Immunogenicity Study of a Quadrivalent Seasonal Flu Vaccine Comprising Recombinant Hemagglutinin-Flagellin Fusion Proteins

3区 · 医学

ArticleOA

作者: Liu, Ge ; Lucksinger, Gregg ; Tussey, Lynda ; Abraham, Katalin ; Umlauf, Scott ; Song, Langzhou ; White, C. Jo ; Strout, Cynthia ; Davis, Matthew ; Johnson, Casey

AbstractBackground. We evaluated the safety and immunogenicity of VAX2012Q, a quadrivalent influenza vaccine comprising 4 hemagglutinin subunits fused to flagellin.Methods. In this dose-ranging, open-label study, healthy adults (18–40 years) were divided into 7 cohorts for evaluation of 5 dose levels and 3 component ratios. Dose levels were as follows: (1) 1 mcg per component of VAX128C (H1N1), VAX181 (H3N2), VAX173 (B-YAM), and VAX172 (B-VIC), respectively; (2) 2 mcg per component, respectively; (3) 2, 4, 4, and 4 mcg of each component, respectively; (4) 2, 4, 6, and 6 mcg of each component, respectively; and (5) 3 mcg per component, respectively. Tolerability and immunogenicity data were analyzed.Results. Three hundred sixteen subjects received VAX2012Q (309 per protocol). At all dose levels, 54% to 65% of subjects reported mild injection site pain, the most common local reaction. Moderate injection site pain increased at dose levels 2 through 5 (22%–42%, compared with 20% at dose level 1). Systemic symptoms were mostly mild to moderate with moderate symptoms increasing in dose levels 3 and 4. Three dose level 3 subjects (6%) reported severe, transient chills and or fever. Mean fold rises in hemagglutination inhibition titers ranged from 2.5 to 6.9 despite high baseline titers. Mean seroprotection rates were ≥90% and mean seroconversion rates were ≥40% for all strains in all groups postvaccination.Conclusions. VAX2012Q elicited immune responses at all dose levels with no significant safety concerns. Doses of 2 or 3 mcg per component provided a favorable balance of tolerability and immunogenicity.

100 项与 VAX-2012Q 相关的药物交易

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研发状态

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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2期	澳大利亚	VaxInnate Corp.	2014-11-01

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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


NCT02015494 (pubmed \| Open Forum Infect Dis) 人工标引	临床1期	-	-	VAX2012Q	(網範夢簾構膚窪醖壓鬱) = 餘網夢淵餘糧鑰選壓顧鑰構鹹築糧鏇淵獵餘鹹 (醖憲鬱繭網願獵繭觸繭 ) 更多	积极	2016-01-29