Non-inferiority study of adjuvanted vs. high dose flu vaccine in residents of long term care

长期护理居民中佐剂与高剂量流感疫苗的非劣效性研究

基本信息

  • 批准号:
    9412645
  • 负责人:
  • 金额:
    $ 79.99万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2017
  • 资助国家:
    美国
  • 起止时间:
    2017-12-01 至 2020-11-30
  • 项目状态:
    已结题

项目摘要

Project Summary / Abstract Influenza and pneumonia are the most common infection-related and vaccine-preventable causes of hospitalization and death. Over 90% of influenza-related deaths occur among the 13% of adults aged >65 years. Over 2 million Americans reside in nursing homes, skilled nursing facilities, or long-term residential care facilities, a number the CDC projects will significantly grow in the coming decades. These seniors rank highest for risk of influenza complications. Two influenza vaccines now available are FDA approved specifically for persons over age 65: the newly approved adjuvanted seasonal influenza vaccine (Fluad®) and the increasingly used high dose (HD(FluzoneHD®)) vaccine approved in 2009. The absolute or relative clinical advantage to long-term care residents of Fluad vs. HD over non-adjuvanted standard dose (SD) vaccine remains unclear from existing immunologic and clinical evidence. Fluad and HD have not been compared head-to-head and an industry-sponsored study is unlikely to be conducted to evaluate relative efficacy or effectiveness due to uncertainty as to whether manufacturers will gain additional market advantage while risking uncovering relative inferiority. Both Fluad and HD vaccine have been shown individually to be more effective than SD vaccine in trials conducted in different cohorts and years. HD vaccine is more expensive than SD vaccine, and Fluad is less expensive than HD vaccine. As an adjuvanted vaccine, Fluad has been shown to have higher levels of heterologous immunity to drifted influenza strains than non-adjuvanted (SD) vaccine - another potential advantage of Fluad over HD vaccine, which is non-adjuvanted. Heterologous immunity is particularly important in bad match years when the CDC's strain choices for vaccine composition in that season are incorrect. Also, adjuvant is used in vaccines in general to maintain higher antibody titers for a longer period of time. This project's rationale and innovation derive from its ability to help determine the best use of these two vaccines in the setting of one of the most vulnerable elderly populations - those living in long-term care (LTC) settings such as nursing homes (NH). Overall the immunogenicity and clinical analyses they propose here are essential to provide support and rationale as to whether an enormously more expensive multi-site clinical endpoint RCT to compare these two vaccines is warranted. Hypothesis: Adjuvanted flu vaccine, Fluad, is not immunologically inferior to HD influenza vaccine in older persons living in long-term care. They propose a non-inferiority randomized clinical trial to enroll 558 NH residents age 65 and older to receive either Fluad or HD vaccine at 1:1 ratio. Blood will be sampled pre- and post-vaccine (1 mo after vaccination) and after the influenza season is over for blinded laboratory analysis. Aim 1. Primary objective: To determine if Fluad is immunologically non-inferior to HD influenza vaccine in NH residents over age 65. Aim 2: Secondary objective: To determine if Fluad has greater heterologous immunity than HD vaccine. Aim 3: Pilot clinical objective: To determine if Fluad has similar protective efficacy to HD vaccine.
项目摘要/摘要

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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DAVID H CANADAY其他文献

DAVID H CANADAY的其他文献

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{{ truncateString('DAVID H CANADAY', 18)}}的其他基金

Immunogenicity of recombinant zoster vaccine in Rheumatoid arthritis patients
重组带状疱疹疫苗对类风湿关节炎患者的免疫原性
  • 批准号:
    10663064
  • 财政年份:
    2021
  • 资助金额:
    $ 79.99万
  • 项目类别:
Immunogenicity of recombinant zoster vaccine in Rheumatoid arthritis patients
重组带状疱疹疫苗对类风湿关节炎患者的免疫原性
  • 批准号:
    10426040
  • 财政年份:
    2021
  • 资助金额:
    $ 79.99万
  • 项目类别:
Epidemiology, transmission and immunology of COVID-19 in nursing home residents
疗养院居民中 COVID-19 的流行病学、传播和免疫学
  • 批准号:
    10326526
  • 财政年份:
    2020
  • 资助金额:
    $ 79.99万
  • 项目类别:
Mechanisms of increased susceptibility to TB in HIV-Infected individuals
HIV 感染者对结核病易感性增加的机制
  • 批准号:
    8059671
  • 财政年份:
    2010
  • 资助金额:
    $ 79.99万
  • 项目类别:
Mechanisms of increased susceptibility to TB in HIV-Infected individuals
HIV 感染者对结核病易感性增加的机制
  • 批准号:
    7840614
  • 财政年份:
    2010
  • 资助金额:
    $ 79.99万
  • 项目类别:
Mechanisms of increased susceptibility to TB in HIV-Infected individuals
HIV 感染者对结核病易感性增加的机制
  • 批准号:
    8239554
  • 财政年份:
    2010
  • 资助金额:
    $ 79.99万
  • 项目类别:
Mechanisms of increased susceptibility to TB in HIV-Infected individuals
HIV 感染者对结核病易感性增加的机制
  • 批准号:
    8435529
  • 财政年份:
    2010
  • 资助金额:
    $ 79.99万
  • 项目类别:
Predictors of Immunologic Failure in Older Adults
老年人免疫失败的预测因素
  • 批准号:
    7908825
  • 财政年份:
    2009
  • 资助金额:
    $ 79.99万
  • 项目类别:
Predictors of Immunologic Failure in Older Adults
老年人免疫失败的预测因素
  • 批准号:
    8195966
  • 财政年份:
    2009
  • 资助金额:
    $ 79.99万
  • 项目类别:
Predictors of Immunologic Failure in Older Adults
老年人免疫失败的预测因素
  • 批准号:
    7797075
  • 财政年份:
    2009
  • 资助金额:
    $ 79.99万
  • 项目类别:
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