Preventing infectious diseases for healthy ageing: The VITAL public-private partnership project.

Prevention of infectious diseases through immunisation of the growing ageing adult population is essential to improve healthy ageing. However, many licenced and recommended vaccines for this age group show signs of waning of the protective effect due to declining immune responses (immuno-senescence) and decreasing vaccine uptake. Today's major challenge is to improve vaccine effectiveness and uptake and to deploy efficient vaccination strategies for this age group. The Vaccines and InfecTious diseases in the Ageing popuLation (VITAL) project, with partners from 17 academic & research groups and public institutes as well as seven industry collaborators, aims to address this challenge. The ambition is to provide evidence-based knowledge to local decision makers. Using a holistic and multidisciplinary approach and novel analytical methods, VITAL will provide tools that allow the development of targeted immunisation programs for ageing adults in European countries. The project is based on four pillars focussing on the assessment of the burden of vaccine-preventable diseases in ageing adults, the dissection of the mechanisms underlying immuno-senescence, the analysis of the clinical and economic public health impact of vaccination strategies and the development of educational resources for healthcare professionals. By the end of the project, a clear, detailed, and integrated program should be available for implementing a consistent, affordable, and sustainable vaccination strategy for ageing adults with regular evaluations of its impact over time.

A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children.

INTRODUCTION: New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a large body of evidence on their clinical safety in children. METHODS: We carried out a systematic search for safety data from published clinical trials on newly adjuvanted vaccines in children ≤10 years of age. Serious adverse events (SAEs), solicited AEs, unsolicited AEs and AEs of special interest were evaluated for four new adjuvants: the immuno-stimulants containing adjuvant systems AS01 and AS02, and the squalene containing oil-in-water emulsions AS03 and MF59. Relative risks (RR) were calculated, comparing children receiving newly adjuvanted vaccines to children receiving other vaccines with a variety of antigens, both adjuvanted and unadjuvanted. RESULTS: Twenty-nine trials were included in the meta-analysis, encompassing 25,056 children who received at least one dose of the newly adjuvanted vaccines. SAEs did not occur more frequently in adjuvanted groups (RR 0.85, 95%CI 0.75-0.96). Our meta-analyses showed higher reactogenicity following administration of newly adjuvanted vaccines, however, no consistent pattern of solicited AEs was observed across adjuvant systems. Pain was the most prevalent AE, but often mild and of short duration. No increased risks were found for unsolicited AEs, febrile convulsions, potential immune mediated diseases and new onset of chronic diseases. CONCLUSIONS: Our meta-analysis did not show any safety concerns in clinical trials of the newly adjuvanted vaccines in children ≤10 years of age. An unexplained increase of meningitis in one Phase III AS01-adjuvanted malaria trial and the link between narcolepsy and the AS03-adjuvanted pandemic vaccine illustrate that continued safety monitoring is warranted.