What’s the STORY? (Serum Testing Of Representative Youngsters) [COVID-19] [UPH]

  • Research type

    Research Study

  • Full title

    Sero-epidemiological survey of England in 2019/2020\n

  • IRAS ID

    263097

  • Contact name

    Matthew Snape

  • Contact email

    matthew.snape@paediatrics.ox.ac.uk

  • Sponsor organisation

    University of Oxford / Clinical Trials and Research Governance

  • ISRCTN Number

    ISRCTN11952463

  • Clinicaltrials.gov Identifier

    NCT04061382

  • Clinicaltrials.gov Identifier

    CPMS42523, ; ,

  • Duration of Study in the UK

    1 years, 4 months, 30 days

  • Research summary

    Research Summary
    Public Health England has an ongoing sero-prevalence programme to assess how well the population is protected from vaccine preventable diseases. The current way to check this is by testing left-over blood samples from different healthcare laboratories around the country and examine them to see what protection they have from vaccine preventable diseases. There are two problems with this system. Firstly samples may not be representative of the general population particularly in younger age groups and secondly we do not know which vaccines the patients who provided the samples have received. In the Netherlands they use a different system, in which they actively collect new blood samples from a representative cross section of society. This type of approach would address the limitations of using residual serum samples and would be an invaluable resource for understanding the levels of immunity against vaccine preventable disease in the English population. This in turn would allow us to anticipate the re-emergence of new diseases such as measles or diphtheria. We are proposing a pilot study to assess the feasibility of establishing a national sero-epidemiological survey in England in individuals aged 0 – 24 years. We will be focusing initially on Diphtheria and Group C invasive meningococcal disease both of which are vaccine preventable. Each participant will have the study explained to them and if they give consent they will be asked to provide one blood sample and answer a short questionnaire. These samples will then be analysed in a Public Health England laboratory to see if the participant has evidence of immunity against Diphtheria and invasive Group C meningococcal disease. We will produce reports both for publication and for Public Health England. [COVID-19 amendment - 25/02/2020] To include the testing of antibodies against other infectious diseases, specifically COVID-19.

    Summary of Results
    The study recruited 2,963 participants 0-24-years between October 2019 and June 2021, creating a biobank (a collection of blood samples) that captured many demographic characteristics of the paediatric population in England and their corresponding immunisation histories. To date, these samples have provided a unique insight into the prevalence (the proportion of the population affected at a specific time) of SARS-CoV-2 (the virus causing COVID-19) infection-induced antibodies in the serum of children aged 0 to 18 years during the COVID-19 pandemic prior to widespread immunisation within this age group. The prevalence of antibodies has indicated ‘when and where’ SARS-CoV-2 infection rates were increasing in the paediatric populations, and populations at particular risk of infection, as well the proportion of the population with potential immunity against re-infection. This study has also provided insight into the lack of protection against SARS-CoV-2 infection afforded by pre-existing antibodies against seasonal coronaviruses. For future prospective seroprevalence studies, STORY has illustrated the strengths and weaknesses of different sample types (serum, saliva) and antibody targets (spike, nucleocapsid).

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    19/LO/1040

  • Date of REC Opinion

    20 Jun 2019

  • REC opinion

    Favourable Opinion