Title: Vaccine Evaluation Consortium Phase II
Funder: Department of Health and Social Care

Abstract: Background NVEC is an unique collaboration between the HPA, NIBSC and academia with an established track record in delivering high quality research relevant to the development of UK vaccination policy. A wide range of research questions is being addressed under the current RDD grant No. 1217470 in the three vaccine evaluation areas, namely clinical and preclinical assessment of vaccines; vaccine safety; and modelling and economic evaluation. Though funding from the current RDD grant ends in June 2006, there will be an ongoing need for such vaccine evaluation research efforts in order to inform UK vaccination policy. A 5 year work programme is proposed in the three vaccine evaluation areas covering the following: clinical trials studies with new conjugate vaccines or new combinations of existing vaccines for the pediatric and elderly populations and initiation of trials with new vaccines for prevention of healthcare associated infections with a parallel pre-clinical research programme to assist in the development of surrogate markers of efficacy and batch release tests; extension of the existing vaccine safety research work to capture new and powerful data sources, and continuation of the programme of modelling and economic evaluation work to include the assessment of new vaccines such as human papilloma virus vaccine and staphylococcal vaccines. Aims HISTORIC PROJECT - Entire abstract transferred from the previous database into the [Scientific summary background] field of this database. Plan of Investigation HISTORIC PROJECT - Entire abstract transferred from the previous database into the [Scientific summary background] field of this database. Potential Impact HISTORIC PROJECT - Entire abstract transferred from the previous database into the [Scientific summary background] field of this database. Policy Relevance The research outputs delivered through NVEC have direct policy relevance as they form a major part of the evidence base provided to the DH Joint Committee on Vaccination and Immunisation which advises DH on national vaccine policy. The ability to conduct independent investigator-led studies comparing different schedules or vaccines, and with input from JCVI on trial design, has ensured that UK vaccine policy can evolve to meet the population's needs, supported by an appropriate evidence base. Furthermore, as a result of the development of the economic evaluation component of the NVEC work under the existing grant, DH is now increasingly reliant on NVEC cost-benefit analyses for making the economic case to ministers to support the introduction of a new vaccine. Assessment of the epidemiological, and therefore economic impact, of an immunisation programmes is complex since prediction of the impact on disease requires the use of mathematical models that can simulate the transmission dynamics of the infection in the population and can properly take account of the indirect herd immunity effects as well as the direct protective effects of vaccination. The availability of high quality surveillance data generated by the HPA Centre for Infections for model development, parameterisation and validation, together with a cadre of trained modellers and economists, places it in a unique position to provide the robust cost effectiveness evaluations needed to support national policy. Examples of the policy relevance of NVEC research is provided in the accompanying update report.

Lay abstract: The National Vaccine Evaluation Consortium (NVEC) is a tripartite grouping of research in vaccine evaluation, safety and clinical trials and has been providing response research and advice to Policy through requests from JCVI. This research consortium’s primary purpose is to inform the national vaccination policy by providing specific evidence needed to evaluate the clinical effectiveness and cost effectiveness of new, or changes to existing, vaccination programmes. Thus, the consortium plays a valuable role in providing key evidence to support the development of the immunisation programme and to underpin the above proposed key public health outcome measure. It provides the knowledge gaps and specific evidence needs that go beyond what a vaccine manufacturer can provide. The NVEC clinical trials provide the basis for the tender that is put out by DH for the supply of vaccines suitable for use in the UK national immunisation programme.

Research activity codes: 3.4 VACCINES
Health categories: GENERIC HEALTH RELEVANCE