National Immunisation Schedule Evaluation Consortium (NISEC)

Background Immunisation is central to the health of every UK resident. It is essential that the routine immunisation schedule be employed in a way that achieves optimal impact for minimum cost. Means of achieving this include combining vaccinations at the same visit or by allowing different vaccines against the same disease target to be used interchangeably, facilitating procurement of a sustainable supply. The consortium will have the ability to evaluate novel schedules rapidly and to respond to evolving changes in disease epidemiology and outbreaks. Aims To respond to research needs prioritised by the Department of Health and/or the JCVI, including any emergent threat from infectious disease (e.g. influenza pandemics). Current research priorities identified by the consortium that are likely to be relevant include: incorporation of vaccines against Hepatitis B virus (HBV) into the infant immunisation schedule the potential for mixed schedules of HPV vaccines to achieve an expanded breadth of protection against cervical cancer while minimising incremental costs the influence of maternal pertussis immunisation on the persistence to preschool age (3 ½ years) of antibodies induced by infant immunisation Research Plan and methods of investigation To answer these questions the suggested research plan is: a comparison of the immunogenicity of two combination diphtheria-toxoid, tetanus-toxoid, acellular pertussis, Haemophilus influenzae type b, inactivated polio and Hepatitis B vaccines (trade names Vaxelis and Infanrix-hexa) a randomised comparison of the immunogenicity of three HPV vaccine regimens incorporating the recently licensed nonavalent HPV vaccine given at 6 month intervals: i) HPV2 followed by HPV9; ii) HPV9 followed by HPV2; iii) HPV9 followed by HPV9. An extension study evaluating vaccine induced antibodies at 3 ½ years of age following immunisation of infants born to mothers receiving either Repevax, Boostrix, or no pertussis vaccine, in pregnancy As outlined above alternative research priorities may be identified and will be addressed in a flexible manner as needed. Research team This collaboration will combine the expertise, clinical trial capacity and laboratory facilities of Public Health England (including UCL Great Ormond Street Institute of Child Health) and the UK Paediatric Vaccine Group (UKPVG, consisting of the Oxford Vaccine Group, St George s Vaccine Institute, Bristol Children s Vaccine Centre, the University of Southampton and Imperial College). The Oxford Vaccine Group, University of Oxford will provide the administrative lead with responsibility for financial management, clinical trial databases, monitoring and report submission. Public Health England (PHE) will provide statistical support and responsibility for laboratory assays. Across the consortium there is capacity for clinical trials in healthy paediatric, adolescent, maternity, adult and elderly populations, as well as high-risk child and adult populations and a proven record in delivering expedited large-scale studies in the event of emergent health crises. As PHE undertakes the post-marketing surveillance of vaccine preventable diseases, provides scientific secretariat to the JCVI, procures the vaccines for the NHS programme, co-ordinates the implementation of the English programme, provides all clinical and technical guidance to NHS commissioners and providers and undertakes the public communication activities, having PHE in the leadership of the consortium will ensure that the research remains flexible to the needs of the programme. The link between direct evaluation of programme impact undertaken by PHE and the results of immunogenicity studies conducted by NISEC will sustain the reputation of the UK programme as one of the most innovative and evidence-based in the world. Potential Impact It is expected that the above body of work will directly contribute to changes in the UK immunisation schedule across all ages