Vaccine development Phase I, II, and III

Specific challenge

In view of the current epidemic, the WHO has identified the progression of vaccine candidates currently in development as an urgent public health need. Several candidate vaccines are available. Prime/boost vaccine approaches are promising, as they may provide protection against Ebola infection that is of longer duration.

Scope

Design and implementation of Phase I, II, or III clinical development of vaccine candidates, including prime boost combinations against Ebola virus disease (Zaire), to start in early 2015. The applicants must have vaccine candidates available and demonstrate the ability to roll out clinical trial vaccination programmes in EU / Africa, and to conduct studies in areas where Ebola virus disease is endemic. The clinical development programme(s) need(s) to be aligned with the global effort coordinated by the WHO.

Proposals addressing Topic 1 must include plans to set up a Central Information Repository for the Ebola+ programme for sharing results, learnings and data both amongst Ebola+ partners and with the outside community.  The information repository should include (but not exclusively be restricted to): The capability to capture basic experimental data via an electronic lab notebook; A pharmacological screening platform for the capture, analysis and sharing of assay data and a system for capturing, analysing and sharing translational/clinical data. Applicants should in the first instance re-use capabilities that have been developed in other IMI projects and new capabilities should only be developed where no other alternative already exists. Finally any solution should include a strategy that ensures the long term sustainability of the data so that it remains accessible to the scientific community beyond the time-line of the project.

In addition, proposals addressing Topic 1 should include plans to set up a Scientific Advisory Board including proposed membership representing key stakeholders to give scientific and strategic advice to both specific projects and to the overall programme.  Likewise, proposals should include plans to set up an Ethics Board whose role would be to ensure that all activities carried out under the programme fully account for any ethical considerations[1].

It is considered that an IMI2 JU financial contribution of 70-110 million and an EFPIA in-kind contribution of EUR 10-20 million would allow this specific challenge to be addressed appropriately. Nevertheless, this does not preclude submission and selection of proposals requesting other amounts.

Clinical study designs and therefore costs are likely to be influenced by several external factors such as; evolution of the current outbreak in West Africa and the precise requirements of regulatory authorities.

Expected impact

The vaccine development programme(s) are/is expected to provide the data to assess the safety, immunogenicity and efficacy of the candidate vaccine(s) in preventing EVD. The projects are thus expected to have a major impact on global health, both at the individual and the public health level. Learnings from this programme will also have an impact on the worldwide capacity to quickly develop vaccines in situations of global public health emergencies.

Special information

Since the implementation of Phase I, II, and III clinical trials is linked to manufacturing capability, projects funded under Topics 1 and 2 of this Call are expected to work in collaboration to ensure maximal impact.

[1] Ethics pre-screening and ethics review - IMI2 Manual For Submission, Evaluation And Grant Award