This is the first time the new vaccines were trialled in humans and the first human clinical trial of any malaria vaccine to be carried out in Ireland. Completion of this type of “first in human” study (phase one) in Ireland is significant not only for malaria vaccine research, but also for translational research in general in Ireland.
The clinical trial involved 24 Irish volunteers who received the vaccines to assess safety and the immune responses. The vaccines were found to have an excellent safety profile and produced the appropriate immune response, generating specific T cells that are primed to respond to malaria proteins. Combining these vaccines with others in development may lead to a vaccine that could prevent malaria, which would have a huge impact on human health as a result. The vaccines have now progressed to the next phase of clinical trials at the University of Oxford.
The World Health Organization (WHO) estimates that 207 million cases of malaria occurred globally in 2012 and 627,000 malaria deaths. Most cases (80%) and deaths (90%) occurred in Africa and most deaths (77%) were in children under five years of age.
The first author on the study is Dr Eoghan De Barra, Research Fellow, RCSI Department of International Health & Tropical Medicine, who worked with collaborators at RCSI and senior author Professor Adrian Hill, Director of the Jenner Institute at University of Oxford.
Minister for Development, Trade Promotion and North South Cooperation, Mr Seán Sherlock, TD said: “Irish Aid has contributed €8 million to EVI since 2007 and will continue our support into 2015. I am very encouraged to see the positive outcome of this important trial being carried out by Irish researchers as part of an international effort to address a global health problem that affects millions worldwide. Irish researchers are making a contribution to finding new and better products to improve the health of some of the most vulnerable populations in low income countries, and this is supported by longstanding Irish Aid work in vaccine development internationally and through support to EVI.”
Professor Sam McConkey, Head of the RCSI Department of International Health & Tropical Medicine and Senior Author on the study commented: “Malaria remains a major cause of mortality in the world, with almost 700,000 deaths annually. In low income countries where malaria is endemic, the expensive multi-drug therapy required to treat malaria is often not an available option so there is a need for new preventative tools.The results of the RCSI malaria vaccine trial, which demonstrate both safety for the patient and a positive clinical and immunological response, are very promising and represent an important step in the development of an effective vaccine for the disease.”
“Conducting this first in human trial at the RCSI Clinical Research Centre moves Ireland’s research capacity for developing better interventions for human diseases into a new space. All stages of clinical development of new drugs and devices, can now be carried out in Ireland, as well as manufacturing and distribution. This new clinical trial capacity at RCSI in Ireland will enable biotechnology companies and major pharmaceutical manufacturers to carry out the critical steps of moving potential products into human trials in Ireland.” Professor McConkey concluded.
Dr Odile Leroy, Executive Director of EVI said: “It is a great pleasure and honour to see our long-lasting collaboration with RCSI and University of Oxford adding a major piece to the complex scientific puzzle of designing the second generation of malaria vaccine. This would not have been possible without the support of Irish Aid.”
The two new malaria vaccines (ChAd63 CS and MVA CS) were developed at University of Oxford and use the gene for malarial circumsporozoite protein inserted into a weakened adenovirus.
Pictured at the RCSI Education and Research Centre, Beaumont Hospital, Dublin are (L-R), Prof. Samuel McConkey, Principal Investigator and Head of the Department of International Health and Tropical Medicine, RCSI, Ann Collins, Research Nurse, RCSI, Liz Fogarty, Research Nurse, RCSI, Kerrie Hennigan, Research Assistant, RCSI and Dr. Eoghan de Barra, Research fellow, RCSI.
RCSI is a not-for-profit health sciences institute which focuses on education and research to drive positive change in all areas of human health worldwide. RCSI is headquartered in Dublin and is a recognised College of the National University of Ireland. In 2010, RCSI was granted independent degree-awarding status by the State, which enables the College to award degrees alongside its traditional powers to award licentiates.
EVI is a leading European non-profit Product Development Partnership that has the principal objective to develop effective, accessible, and affordable vaccines against malaria and other diseases of poverty. Since its inception in 1998 it has contributed to the development of 32 malaria vaccine candidate formulations with 16 vaccine candidates being advanced into phase I clinical trials, three of which have been transitioned for further clinical development in sub-Saharan Africa. EVI leads global efforts in the development of vaccines against diseases of poverty, while also acting as coordinator of several initiatives/consortia to create harmonisation between all global stakeholders in vaccine research. EV is co-founder of the Malaria Vaccine Funders Group and is hosted by Heidelberg University in Germany. EVI is currently funded by Irish Aid, the European Commission, EDCTP, and the German Federal Ministry of Education and Research (BMBF).