Ebola may not strike the same note of fear that it did a matter of months ago, when it was ravaging the countries of West Africa and threatening to breach Europe’s health defences. Nevertheless its sporadic reappearance is a stark reminder that the fight against this deadly disease is by no means over and must be addressed continuously.
The Innovative Medicines Initiative (IMI) – the world’s largest public-private partnership in the life sciences sector – mobilised early to address the Ebola challenge and IMI2 continues to do so in a variety of important projects. Hope is being created via a network that brings together key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators.
The old maxim is that prevention is better than cure: in medicine terms this often relates to a vaccine. The Ebola+ project under IMI has already been up and running since 2014, when it was launched in response to the Ebola virus disease (EVD) outbreak that erupted in western Africa in the same year. Ebola+ is a comprehensive programme, spanning both IMI and IMI2, and aimed at tackling a wide range of challenges in Ebola research, including vaccines development, clinical trials, storage and transport, together with diagnostics and treatments.
The aim is to accelerate the development of two Ebola vaccine candidates: Ad26.ZEBOV is a monovalent vaccine designed to provide active specific acquired immunity to the Ebola virus; and MVA-BNÒ-Filo is a multivalent vaccine preparation designed to provide active acquired immunity to the Sudan virus, the Ebola virus, the Marburg virus. Both are in development at the Janssen Pharmaceutical Companies of Johnson & Johnson and Bavarian Nordic with support from the Biomedical Advanced Research and Development Authority and the National Institutes of Health.
EBOVAC1, EBOVAC2, EBODAC and EBOMAN are among the eight vaccines projects funded under the IMI Ebola+ programme to the tune of some €215 million.
Phase 1 trials – in which a medicine is tested in human beings for the first time – are being carried in the UK, USA, Kenya, Tanzania and Uganda out under IMI2’s EBOVAC1 project. These trials gather preliminary information on the safety and tolerability of the vaccine regimen. The immune response – how the body reacts to invading microbes or pathogens – generated by the regimen will also be evaluated in the longer term. A Central Information Repository has also been set up under EBOVAC1 to which all data is being channeled, for use by all Ebola+ programme projects as well as the wider community.
EBOVAC2 will oversee phase 2 trials in African and European volunteers, aimed at providing extensive and robust data on the safety and immunogenicity of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The development programme is running at pace, so these phase 2 studies are being conducted in parallel with the ongoing Phase 3 study in Sierra Leone (housed under EBOVAC1).
The EBODAC project focuses on developing a communications strategy and tools to maximise the impact of an Ebola vaccination. These tools include an identification tool using biometric registration and a mobile platform sending reminder and engagement messages. It will be instrumental in confronting the stigma surrounding Ebola and the general suspicion that surrounds vaccines, which often deter people from getting vaccinated.
The aim of the EBOMAN project is to accelerate the development and manufacturing of a ‘prime- boost’ Ebola vaccine regimen. Essentially the projects has two strands: in the short term, it will ensure the delivery of sufficient quantities of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen to support the EBOVAC projects in clinical trials; and it will prepare for a rapid access to additional vaccine production capacity in case of EVD escalation.
It doesn’t stop there, though. Towards the end of 2015, a second wave of Ebola+ projects was planned through the publishing of a Call for proposals on Ebola and related diseases – including other haemorrhagic fevers, such as those caused by the Marburg virus. The Call offers a continuous opportunity via IMI2 to support efforts to ensure the fast development and validation of innovative solutions that will result in an increased readiness to respond to future outbreaks. The idea calls for seamless interaction and collaboration with other Ebola+ projects.
This cornucopia of projects shows just how serious IMI is about combatting Ebola and trying to render it a disease of the past. Without the collaborative aspect of the IMI that pools a variety expertise in each vital project, the fight against Ebola might still be winnable – but it would doubtless last much longer.
We would like to thank colleagues from the IMI projects mentioned for contributing to this blog.0