As part of a 3-year project, the NIBSC will be working with the Oxford Vaccine Group to generate source material for antibody standards from serum obtained from immunised volunteers. This material will then be characterised and assessed in an international multi-centre study.

The NIBSC is also collaborating with the Walter Reed Army Institute of Research in the USA in order to optimise and evaluate immunoassays for the detection of antibodies against the four most clinically relevant subtypes of Shigella.

Group B streptococcus

Group B streptococcus (GBS) bacteria is commonly found in the intestinal and reproductive tract of humans, where it is usually harmless. However, in rare instances GBS can cause serious illness in newborns that have been exposed to the bacteria during labour.

The precautionary administration of antibiotics during childbirth significantly reduces the risk of early onset GBS disease. Nevertheless, maternal vaccination is a more desirable strategy as this would also offer infants protection against late-onset GBS disease. Additionally, the availability of a vaccine will help to reduce the incidence of GBS infection in other vulnerable groups such as immunocompromised individuals and the elderly.  

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.