Early estimation of pandemic antiviral, therapy and vaccine effectiveness (EAVE)

• Research type

  Research Study

• Full title

  Early estimation of pandemic Antiviral, therapy and Vaccine Effectiveness and enhanced surveillance (EAVE) - use of a unique community and laboratory national linked dataset)

• IRAS ID

  114474

• Contact name

  Colin Simpson

• Contact email

  c.simpson@ed.ac.uk

• Sponsor organisation

  ACCORD

• ISRCTN Number

  ISRCTN40292537

• Research summary

  Building on prior work [1-3], we aim to enhance an approach used to determine effectiveness of the 2009 H1N1 influenza pandemic vaccine [2]. By linking primary care clinical, prescribing and vaccination data from 40 sentinel general practices to laboratory serology and swab information using a unique patient identifier the Community Health Index (CHI) number [HTA refs: 09/84/90] we will be able to determine once a new pandemic is underway:\n\n•\tThe uptake and effectiveness of any new pandemic vaccine once available;\n\nand using already collected serological information and swab data:\n\n•\tThe existence of any protective effect provided by previous exposure to and vaccination from A/H1N1 pandemic or seasonal influenza/identification of susceptible groups.\n•\tThe attack rate of pandemic influenza.\n•\tThe analysis of any protective effect conferred by antivirals & other therapeutuc agents\n\n\n[COVID-19 amendment 03/04/2020] The NIHR in 2019 requested from the NIHR Pandemic Influenza Portfolio of projects a document to set out our ability to redirect a set of hibernated projects to new/emerging infections [Simpson CR, et al. The UK’s pandemic influenza Building on prior work [1-3], we aim to enhance an approach used to determine effectiveness of the 2009 H1N1 influenza pandemic vaccine [2]. By linking primary care clinical, prescribing and vaccination data from 40 sentinel general practices to laboratory serology and swab information using a unique patient identifier the Community Health Index (CHI) number [HTA refs: 09/84/90] we will be able to determine once a new pandemic is underway:\n\n•\tThe uptake and effectiveness of any new pandemic vaccine once available;\n\nand using already collected serological information and swab data:\n\n•\tThe existence of any protective effect provided by previous exposure to and vaccination from A/H1N1 pandemic or seasonal influenza/identification of susceptible groups.\n•\tThe attack rate of pandemic influenza.\n•\tThe analysis of any protective effect conferred by antivirals & other therapeutuc agents research portfolio: a model for future research on emerging infections. Lancet Infect Dis 2019; 19: e 295-e300]. We now have been asked to trigger our portfolio, launching a suite of projects to provide the evidence needed for our health systems. The EAVE project has been enabled by the Scottish Government who have funded a larger (n<250 practices and wider proposal - including additional variables of interest). The most substantial change in our protocol is the title (page 1) which has been simplified to be more generic (to ensure a simplified process if activation occurs again).\nNew title: Early estimation of pandemic Antiviral, therapy and Vaccine Effectiveness and enhanced surveillance (EAVE) - use of a unique community and laboratory national linked dataset) Elsewhere we describe the increase in practices, the addition of the need to pivot COVID-19 and novel research questions and the addition of new datasets which were not widely available when EAVE was put into hibernation.

• REC name

  South East Scotland REC 02

• REC reference

  12/SS/0201

• Date of REC Opinion

  15 Nov 2012

• REC opinion

  Favourable Opinion