Serosurveillance study of maternally derived anti-pertussis antibody

• Research type

  Research Study

• Full title

  Using Guthrie cards for a serosurveillance study of maternally-derived antibody against pertussis

• IRAS ID

  234583

• Contact name

  Kirsty Le Doare

• Sponsor organisation

  St George's University of London

• Duration of Study in the UK

  2 years, 0 months, 24 days

• Research summary

  Research Summary:

  During the pertussis outbreak in 2012, over 400 babies in England developed pertussis disease and ten babies died. Maternal vaccination against pertussis was introduced to try and stop the outbreak and has been part of the UK vaccination programme since. Vaccinating mothers enables them to pass antibodies via the placenta that protect their babies until they complete their primary childhood vaccinations. However, we do not know exactly how much antibody is needed to protect babies from this deadly disease. We need to collect comprehensive information about the amount of antibody that protects infants from pertussis in order to inform the maternal vaccination programme. Taking blood from babies is difficult and we have identified that dried blood spots (DBS) from newborn bloodspot cards, taken for national newborn screening are a good alternative. Cards from 2012 are due to be disposed of in 2017 giving us an ideal opportunity to test for baby antibody without the need for baby blood tests. We aim to undertake a study comparing antibody from DBS from 150 infants with pertussis that occurred during 2012 with DBS from 300 healthy controls. We will do this by using the PHE national surveillance that identifed babies with pertussis disease and requesting laboratories storing the cards to take up to two of the DBS that remain on the card for analysis. We will also ask the laboratories to pick two other cards taken at
  the same time to act as our healthy controls. We will then use the antibody test developed at Public Health England to measure antibody concentrations to work out how much antibody is needed to protect babies from pertussis.

  Lay Summary of Results:

  342 stored dried blood spots (DBS) were collected from newborn screening laboratories across the UK in 2018. Case samples were collected from infants with confirmed pertussis disease in 2011/2012 and control samples were matched at each laboratory for gestation, sex and ethnicity. Prior to commencing testing on all samples, a subset of samples was quality checked by assessing total Immunoglobulin G (IgG) levels. Results from this initial testing indicated that the antibody concentrations in the DBS were too low to be measured, despite using enhanced antibody elution methods. This demonstrates that DBS samples degrade over time and that this may be as a result of their storage conditions. Our investigations suggest that DBS samples should be stored at -20°C, and at lower temperatures for long-term storage (>6 month), if this potentially valuable resource is to be used for antibody studies in the future.

• REC name

  North East - York Research Ethics Committee

• REC reference

  17/NE/0323

• Date of REC Opinion

  12 Oct 2017

• REC opinion

  Favourable Opinion