As for shigella, there are no licensed vaccines for GBS at present but candidates in development have shown great promise. Consequently, there is an urgent need for standardised immunoassays that can assure vaccine quality.As for shigella, there are no licensed vaccines for GBS at present but candidates in development have shown great promise. Consequently, there is an urgent need for standardised immunoassays that can assure vaccine quality.
In this 3-year project, the NIBSC will work with Pfizer to produce a WHO international reference serum standard. It will be composed of pooled serum from individuals immunised with a GBS vaccine containing the six most prevalent serotypes of the bacteria. This standard will also be assessed and calibrated in an international collaborative study to ensure that it is fit for purpose. A further aim of the project is to develop an affordable immunoassay that can be used by the GBS community to quantify GBS antibodies.
Supporting vaccine development
The outputs of both of these standardisation projects will enable the comparison of data from different laboratories and vaccines. This in turn will facilitate licensure of the most promising vaccine candidates for Shigella and GBS.
Dr Paul Stickings, interim Head of Bacteriology at the NIBSC comments that:
“These projects build on the well-established expertise of NIBSC in the development, production and characterisation of reference standards. The collaborations with academia and industry, supported by the BMGF, will help to ensure the project engages relevant stakeholders and that the reference materials produced will facilitate the development and evaluation of vaccines against Shigella and GBS.”
Further information on our bacteriological standardisation, research and control testing work is available here.