Ebola vaccine trial funding announced by Innovative Medicines Initiative
16 January 2015London School of Hygiene & Tropical Medicine London School of Hygiene & Tropical Medicine https://lshtm.ac.uk/themes/custom/lshtm/images/lshtm-logo-black.png
The London School of Hygiene & Tropical Medicine is to coordinate clinical trials of a vaccine candidate for Ebola virus disease, it was announced today by the EU Innovative Medicines Initiative (IMI).
The trials are part of the IMI Ebola+ programme, a series of eight projects covering vaccine development and manufacture, as well as diagnostics, community education and compliance. The announcement comes in the run up to the World Economic Forum in Davos, where Ebola will feature high on the agenda.
Phase I safety trials started this month in Europe, and will be followed by Phase II and III trials to assess the safety and tolerability of a new 'prime-boost' Ebola vaccine regimen being developed by Janssen Pharmaceutical Companies of Johnson & Johnson.
Patients are first given a prime to the immune system to stimulate an initial immune response, and then a boost intended to further enhance the level of the body's immune response over time, that should ensure optimal and long-lasting protection against Ebola. The vaccine does not contain any replicating virus, so it is not possible to be infected with Ebola.
The Phase II and III trials in Europe and Africa, subject to review of the preliminary Phase I data, will be carried out in parallel. In these trials, larger groups of people will receive the vaccine regimen, allowing the projects to gather further information on the regimen's safety and tolerability, including in specific groups such as children and the elderly, and to assess its efficacy against Ebola virus.
Partners in the two consortia for trials and vaccine development also include Inserm (L'Institut national de la santé et de la recherche médicale), the University of Oxford and La Centre Muraz, alongside other collaborating research institutes across Africa.
School researchers are also co-ordinating another consortium to overcome the stigma surrounding Ebola and suspicion of vaccines in general. Working with Janssen, Grameen Foundation, and World Vision, they will develop a communication strategy, tools and mobile technologies to promote the acceptance and uptake of new Ebola vaccines.
Professor Peter Piot, Director of the London School of Hygiene & Tropical Medicine, and co-discoverer of the Ebola virus, said: "It is vital that we work together to accelerate the development of an effective vaccine, both for the current epidemic and future outbreaks. We must take this opportunity to make sure that this is the last Ebola epidemic in which our only tools to control it are isolation and quarantine."
A total of eight projects have been selected for funding under the IMI Ebola+ programme with a total budget of €215 million (approx. £165 million) announced today, three of them involving the School. All received funding from the Innovative Medicines Initiative 2 Joint Undertaking, supported by the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
European Commissioner for Research, Science and Innovation Carlos Moedas said: "There is no vaccine or treatment against Ebola as yet, so we must urgently step up our efforts in Ebola research. With this funding from Horizon 2020 and our industry partners, we are speeding up the development of an Ebola vaccine as well as rapid diagnostic tests to aid heroic health workers. These are the tools we need to defeat Ebola once and for all."
Links and notes:
The projects in which the School is a partner are:
Vaccine development in Phase I, II, and III (EBOVAC 1 & 2)
Consortium members: Janssen, London School of Hygiene & Tropical Medicine, Oxford University, Inserm (L'Institut national de la santé et de la recherche médicale), Inserm Transfert, Le Centre Muraz
Between them, the two EBOVAC projects will assess, through clinical trials in Europe and Africa, the safety and tolerability of the 'prime-boost' Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. Phase I trials will be carried out by the EBOVAC1 project, to gather preliminary information on the safety and tolerability of the vaccine regimen, and the immune response longer term. The Phase II and III trials, subject to review of the preliminary Phase I data, will be carried out in parallel by the EBOVAC2 and EBOVAC1 projects respectively to speed up the clinical development of the vaccine.
Deployment and compliance of vaccination regimens (EBODAC)
Consortium members: Janssen, London School of Hygiene & Tropical Medicine, Grameen Foundation, World Vision of Ireland
The stigma surrounding Ebola, coupled with a suspicion of vaccines in general, could deter many people from getting vaccinated. The EBODAC project will develop a communication strategy and tools to promote the acceptance and uptake of new Ebola vaccines. One of the project's most important products will be a platform, based on mobile technology, dedicated to providing local communities with information on Ebola and vaccines, and will send reminders to people receiving the 'prime boost' vaccine to return to get their second 'booster' dose and facilitate the tracking of vaccination coverage. EBODAC will also set up local training programmes to make sure the communication strategy and tools are ready for deployment in local settings.
About the Ebola Vaccine Regimen
The vaccine regimen used here, which was discovered in a collaborative research program with the National Institutes of Health (NIH), uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic, a biotechnology company based in Denmark.
It has been identified by the World Health Organization (WHO) as one of the three most promising candidate vaccines currently being tested. The others, both single-shot vaccines, are being developed by GSK/US National Institutes for Health and Merck & Co, respectively.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking, which receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.