Adjuvanted Influenza Vaccine

佐剂流感疫苗

基本信息

  • 批准号:
    7270972
  • 负责人:
  • 金额:
    $ 30万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2007
  • 资助国家:
    美国
  • 起止时间:
    2007-08-01 至 2009-07-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Seasonal influenza constitutes a significant healthcare problem in the U.S., with an estimated 17 to 50 million persons affected yearly. Influenza was responsible for an average of 36,000 deaths annually throughout the decade 1990-1999. Elderly patients are at particular risk, accounting for 80-90% of influenza related deaths. In the US, the economic cost of the annual flu season is estimated at $ 71-167 billion. The principal means of preventing influenza is by immunization with seasonal influenza vaccine. Influenza vaccination, which has efficacy rates from 70-90% in young adults, is effective in only 27-75% in elderly subjects. A vaccine that increases efficacy in the elderly would be of significant benefit. In addition, influenza vaccine with greater immunopotency than the present vaccine would have a significant beneficial impact where vaccine supplies were scarce, such as for emerging strains of influenza virus or for shortfalls in manufacture of seasonal vaccine stocks. Such a dose-sparing effect would stretch vaccine stocks to help ensure sufficient supplies to protect the U.S. population. Moreover, the enhanced immunopotency could have an epitope spreading effect, where antibodies are produced against less dominant epitopes, thereby increasing the possibility of cross reactivity with other strains of influenza virus. The objective of this program is to develop a prophylactic influenza vaccine to help fulfill these needs. The approach combines a potent new adjuvant, MAS-1, which has an established safety record from over 20 clinical trials, with approved seasonal influenza vaccine antigens. MAS-1 is advantageous in that it can be formulated to cGMP by a fully validated process in a licensed facility on a large scale adequate for prophylactic vaccines or it can be formulated at the clinic with pre-distributed MAS-1 adjuvant vehicle and standard influenza vaccine antigens by a validated point-of-use mixing method. Both formulation methodologies will be assessed with seasonal influenza vaccine in this program. The work will include initial formulation testing to confirm mixing parameters for MAS-1 influenza vaccine. This will be followed by proof of concept studies in laboratory animals to demonstrate that MAS-1 enhances the antibody response to the three component strains of virus in the seasonal influenza vaccine, in comparison with standard (non- adjuvanted) vaccine. These studies will include dose ranging to establish effective doses of influenza antigens and of injection volume, and the outcome will be based primarily on the measurement of anti-H antigen antibody titers by the standard hemagglutination inhibition assay. A sub-acute, pre-clinical toxicology study will be performed on the MAS-1 influenza vaccine to confirm safety as a prelude to clinical evaluation. This two year program will culminate in the preparation and filing of an IND for clinical trials of MAS-1 influenza vaccine.
描述(由申请人提供):季节性流感在美国构成了一个重大的医疗保健问题,估计每年受影响的17至5000万人。在1990 - 1999年期间,流感造成平均每年36,000人死亡。老年患者特别有风险,占流感相关死亡的80-90%。在美国,年度流感季节的经济成本估计为71.67亿美元。预防流感的主要手段是通过季节性流感疫苗免疫。流感疫苗接种的年轻人的疗效率从70-90%的疗效率仅在老年受试者中有效27-75%。提高老年人功效的疫苗将具有重大利益。此外,与本疫苗相比,具有更大免疫力的流感疫苗将对疫苗供应稀少,例如流感病毒的新兴菌株或用于生产季节性疫苗库存的短缺。这样的剂量分配作用将扩大疫苗库存,以帮助确保足够的供应来保护美国人口。此外,增强的免疫能力可能具有表位扩散效果,在这种抗体中与较少的显性表位产生抗体,从而增加与其他流感病毒菌株交叉反应性的可能性。该计划的目的是开发一种预防性流感疫苗,以帮助满足这些需求。该方法结合了一个有效的新辅助MAS-1,该辅助辅助剂具有20多个临床试验的既定安全记录,并获得了批准的季节性流感疫苗抗原。 MAS-1是有利的,因为它可以通过有执照的设施中的完全验证的工艺配制为CGMP,这是足够的大规模预防性疫苗,或者可以通过预先分布的MAS-1辅助车和标准流感疫苗在临床上配制,并通过有效的混合使用点混合方法来配制。在该计划中,将通过季节性流感疫苗评估两种配方方法。这项工作将包括初始配方测试,以确认MAS-1流感疫苗的混合参数。随后将在实验动物中进行概念研究证明,以证明MAS-1与标准(非辅助)疫苗相比,在季节性流感疫苗中增强了对病毒三个成分菌株的抗体反应。这些研究将包括剂量范围以建立有效剂量的流感抗原和注射量,并且结果将主要基于通过标准的血液凝集抑制测定法测量抗H抗原抗体滴度。将对MAS-1流感疫苗进行亚急性的临床前毒理学研究,以确认安全性作为临床评估的前奏。这项为期两年的计划将在制备和提交MAS-1流感疫苗的临床试验的IND中达到顶峰。

项目成果

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Peter Blackburn其他文献

Peter Blackburn的其他文献

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{{ truncateString('Peter Blackburn', 18)}}的其他基金

Therapeutic Vaccine for Asthma
哮喘治疗疫苗
  • 批准号:
    7538915
  • 财政年份:
    2008
  • 资助金额:
    $ 30万
  • 项目类别:
Therapeutic Vaccine for Asthma
哮喘治疗疫苗
  • 批准号:
    7662446
  • 财政年份:
    2008
  • 资助金额:
    $ 30万
  • 项目类别:
Adjuvanted Influenza Vaccine
佐剂流感疫苗
  • 批准号:
    7471548
  • 财政年份:
    2007
  • 资助金额:
    $ 30万
  • 项目类别:

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