Influenza is a major public health problem. In a conservative estimate, influenza infects annually 60 of the 500 million inhabitants of the EU. Vaccines are the cornerstone for preventing influenza and its consequences. Current influenza vaccines have a moderate variable effect, given the mismatch between vaccine and circulating strains, waning immunity and interference from previous vaccination, among others. The single most important challenge in achieving VE studies for the various influenza vaccines put every year on the European market is the ability of the different stakeholders to work in collaboration. To enable a sustainable network of influenza vaccine VE studies, the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) main goal will be the development of a governance model between public and private entities. This model will ensure scientific independence in the studies and full transparency, allowing different stakeholders to fulfill their needs taking into account their respective obligations and statutes. A second challenge will be to reach the capacity to perform vaccine brand- specific effectiveness studies, which is agile enough to deliver the needed outputs in timely manner, and robust enough to provide results by different age and risk groups and flexible enough to utilize novel tools while at the same time aims to be sustainable. Combining these outputs, DRIVE will establish a sustainable platform for joint influenza vaccine effectiveness evaluation which will have a positive impact on European citizens public health.

The first Ebolavirus Zaire (EBOV) outbreak of 2014 was declared on 22 March in Guinea. As of 30 September 2014, the World Health Organization (WHO) reports the total number of cases in the current outbreak of Ebola virus disease (EVD) in West Africa at 7470, with 3431 deaths. The US Centers for Disease Control and Prevention states that the number of cases is currently doubling every 20 days and estimates the true number of cases at 2.5 times higher than that reported. Countries that have been affected are Guinea, Liberia, Nigeria, Senegal and Sierra Leone. Ten percent of fatalities have occurred among front line health care workers attempting to contain the epidemic. On 7 August 2014, the WHO requested that GSK “fully engage in WHO-coordinated efforts to test, license and make available safe and effective Ebola interventions” to assist in the control of the outbreak. Taking into account the early stage of development, EbolaVac seeks to accelerate the clinical development of the GSK chimpanzee adenovirus type 3 Ebolavirus Zaire (ChAd3-EBO Z) vaccine candidate to make the vaccine available to frontline health care workers at risk and to be used in the containment of EBOV outbreaks. The project specifically aims to: (i) complete Phase 1 development of the ChAd3-EBO Z vaccine by supporting a clinical study conducted in Lausanne, Switzerland (WP2); (ii) evaluate the ChAd3-EBO Z vaccine in Phase 2 testing on adults and children at established clinical study centers in West Africa outside the current most heavily affected countries of Guinea, Sierra Leone, and Liberia (WP3); (iii) investigate immunological effects of vaccination and the effect of booster vaccination (WP4) and (iv) centrally manage and analyse clinical study data (WP5). Besides using an innovative vaccine technology, much of the innovation of this program will reside in its capacity to implement vaccine evaluation under significant time pressure and complex logistical challenges while maintaining appropriate quality standards.

The TBVAC2020 proposal builds on the highly successful and long-standing collaborations in subsequent EC-FP5-, FP6- and FP7-funded TB vaccine and biomarker projects, but also brings in a large number of new key partners from excellent laboratories from Europe, USA, Asia, Africa and Australia, many of which are global leaders in the TB field. This was initiated by launching an open call for Expressions of Interest (EoI) prior to this application and to which interested parties could respond. In total, 115 EoIs were received and ranked by the TBVI Steering Committee using proposed H2020 evaluation criteria. This led to the prioritisation of 52 R&D approaches included in this proposal. TBVAC2020 aims to innovate and diversify the current TB vaccine and biomarker pipeline while at the same time applying portfolio management using gating and priority setting criteria to select as early as possible the most promising TB vaccine candidates, and accelerate their development. TBVAC2020 proposes to achieve this by combining creative “bottom-up” approaches for vaccine discovery (WP1), new preclinical models addressing clinical challenges (WP2) and identification and characterisation of correlates of protection (WP5) with a directive “top-down” portfolio management approach aiming to select the most promising TB vaccine candidates by their comparative evaluation using objective gating and priority setting criteria (WP6) and by supporting direct, head-to head or comparative preclinical and early clinical evaluation (WP3, WP4). This approach will both innovate and diversify the existing TB vaccine and biomarker pipeline as well as accelerate development of most promising TB vaccine candidates through early development stages. The proposed approach and involvement of many internationally leading groups in the TB vaccine and biomarker area in TBVAC2020 fully aligns with the Global TB Vaccine Partnerships (GTBVP).