Experimental Human Pneumococcal Carriage Model Testing New Strains

  • Research type

    Research Study

  • Full title

    Experimental Human Pneumococcal Carriage Model (Programme Grant) Research: working towards a nasal vaccine for pneumonia The effect of new strains (types) of bacteria in healthy participants

  • IRAS ID

    193680

  • Contact name

    Jamie Rylance

  • Contact email

    jamie.rylance@lstmed.ac.uk

  • Sponsor organisation

    Royal Liverpool and Broadgreen University Hospital

  • ISRCTN Number

    ISRCTN68323432

  • Duration of Study in the UK

    2 years, 10 months, 31 days

  • Research summary

    Why? Pneumococcus bacteria can cause severe infection such as pneumonia, sepsis and meningitis particularly in those with lower immunity, the very young and elderly. Vaccines protect against a few of the many sub-types of the pneumococcal bacteria.
    How? To develop new vaccines we have established an Experimental Pneumococcal Carriage Model that allows healthy volunteers to carry these bacteria in their nose safely. This bacteria is commonly present in the nose of healthy adults without any sign of illness (10%) and more often carried by children (50%) this carriage may develop a natural immunity to the infection. Over 400 healthy volunteers have taken part in EHPC .
    What? this study aims to find out if two more types of this bacteria (strains) can be carried in the nose, how much remains and how long it is carried for then used to develop new vaccines.
    Who? To make sure participants are safe we will recruit healthy adults who are at less risk of infection.
    Where? The study will be conducted at the clinical research facility in Royal Liverpool University Hospital. Healthy volunteers will be recruited from the local advertising at Universities and in public places
    How? Part one will take 3-4 weeks. A few drops of the live bacteria are put into the nose then we collect secretions from the nose and take blood samples. If these bacteria do not remain in the nose we will increase the dose in the next group. Those who carry the bacteria will be invited to repeat this after 3- 6 months to see if they have developed natural immunity . We ask participants to report any early signs of infection, we provide a thermometer and antibiotics to identify and treat infection early. The research team are available any time day or night and will provide access to health care.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    15/NW/0931

  • Date of REC Opinion

    22 Dec 2015

  • REC opinion

    Favourable Opinion