Our group performs batch release tests on vaccines used to prepare for emergencies – including a recently licensed smallpox vaccine – as well as vaccines used in childhood immunisation programmes such as measles, mumps and rubella (MMR) vaccines.
We support this quality assessment through improving or redesigning assays to ensure we provide the appropriate specifications for the market release.
We contribute to pre-licensing discussions as scientific experts for the European Medicines Agency and have drafted new OCABR guidelines for the control testing of modified vaccinia Ankara (MVA)-based smallpox vaccines.
We are working with different laboratories to evaluate new bioassays to confirm how useful they are in control testing of vaccines with complex read-outs.
Since PCR is likely to become more prevalent as a read-out in vaccine control assays, our group is maintaining links with manufacturers to ensure new assays are introduced efficiently.
As well as improving the methodologies for evaluating the quality of vaccines, we develop reference materials to standardise these tests.
Currently we are working with the National Institutes for Food and Drug Control (NIFDC) in China to develop World Health Organisation (WHO) International Standards for Japanese encephalitis virus vaccines (JEV). These will be valuable in standardising the potency evaluation of these vaccines across different laboratories as well as supporting consistent vaccine manufacture.
We are also developing standards for JEV antibodies to help effectively evaluate vaccine efficacy in vaccinees. We are collaborating with members of the WHO South East Asia Region Network and direct collaborative studies for the evaluation of the candidate standards.
We have pre- and post-doctoral scientists contributing to the research programme. We collaborate within and outside NIBSC, including academia. We carry out research in assay development, standardisation and fundamental knowledge of the viruses. This means we can not only develop better control assays and reference materials but we can also respond to issues relevant to the safety, efficacy and quality of viral vaccines.
We are also identifying vaccine responses in model systems for viruses for which there are currently no licensed vaccines.
For rotavirus we are applying deep sequencing methods to the characterisation of circulating rotavirus strains – particularly in the UK as the infant rotavirus immunisation programme has begun.
We are also developing bioassays to improve our ability to characterise the immune response to rotavirus which will help evaluate vaccine efficacy as well as the development of novel vaccines.
Using a surrogate virus system for the study of hepatitis C virus (HCV) – GBV-B - we are identifying factors that correlate with clearance of virus from an infected individual, and antigens that will be central to the development of prophylactic and therapeutic vaccines against HCV.
Deep sequencing to reveal far greater virus sequence variability than previously recognised opens the door for exploiting our system for evaluating vaccine efficacy and novel HCV direct-acting antivirals.
A current EU-funded study is aimed at characterising biomarkers of disease, with a focus on micro RNAs (miRs), to evaluate disease pathology using less invasive techniques. This will apply to the evaluation of the effects of therapeutic vaccines and antivirals on the target organ.
On HIV, we contribute to the understanding of primate immunogenetic diversity and susceptibility to disease with a particular focus on major histocompatibility complex (MHC) diversity in the macaque model of HIV infection and vaccine development.
We have shown that knowledge of the MHC background allows successful passive transfer of lymphocytes between individuals. Using this approach means it should be possible to better investigate responses involved in effective vaccination.
Dr Nicola Rose, Principal ScientistDr Jane Mitchell, Post-doctoral scientistLedicia Botas Pérez, PhD StudentEmma Summersgill, Scientist