Newswise — Baltimore, MD (USA) and London, England (UK), August 28, 2014 –The Center for Vaccine Development at the University of Maryland School of Medicine is leading an internationally-acclaimed consortium of scientists in an unprecedented multi-trial collaboration to test a potential vaccine that could help prevent the continuing spread of the deadly Ebola virus.
Myron M. Levine, M.D., D.T.P.H, who is the Simon and Bessie Grollman Distinguished Professor and Director of the UM SOM Center for Vaccine Development (CVD) and Samba Sow, M.D., M.S. Adjunct Professor of Medicine at the UM SOM and Director General of the UM SOM CVD-Mali, will lead the testing of the new candidate vaccine in the Republic of Mali in West Africa, where Dr. Levine and his team are internationally recognized for their longstanding work in developing vaccines and improving the health of the nation’s citizens. The CVD has earned a global reputation as an academic vaccine development enterprise for creating and testing vaccines against cholera, typhoid fever, paratyphoid fever, non-typhoidal Salmonella disease, shigellosis (bacillary dysentery), Escherichia coli diarrhea, malaria, and other infectious diseases, including influenza.
Human trials of the new candidate Ebola vaccine, being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic, which the World Health Organization recently declared a public health emergency of international concern.
A £2.8 million grant (approximately $4.64 million in U.S. dollars) from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the US run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).
“This is an extraordinary effort of multiple groups working together to bring a promising early stage candidate Ebola vaccine to field tests in West Africa in record time,” Dr. Levine said. On short notice, the project partners have contributed enormous energy, time and resources to respond to the Ebola disease calamity. If the vaccine trials begin according to schedule, a new paradigm will have been established whereby multiple agencies mobilize to address a public health threat by accelerating the preliminary evaluation of a promising potential public health tool.”
The phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are granted, the UK research teams could start vaccinating volunteers by mid-September.
The candidate vaccine is against the Zaire species of Ebola, which is the one circulating in West Africa, and uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola. Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that it provides promising protection in non-human primates exposed to Ebola without significant adverse effects.
To accelerate these trials, the NIH has generously agreed to provide the NIAID/GSK Ebola vaccine for safety studies led by the Oxford team, which will run in parallel to its own trials. Oxford’s Jenner Institute also has extensive experience conducting clinical trials of similar vaccines, which they have evaluated clinically for six other diseases in Europe and Africa.
If the first volunteers vaccinated in the Oxford study show a good response with no adverse reactions, the trial will, after approval from the relevant authorities, be extended to volunteers at the MRC Unit in Gambia. The second West African arm of the study, led by Dr. Levine and Dr. Sow of the Center for Vaccine Development in Mali (a joint initiative between the University of Maryland School of Medicine and the Ministry of Health of Mali), will then begin in Bamako, Mali.
“The international leadership of Dr. Levine and the CVD in this extraordinary assemblage of leading scientists from around the world truly exemplifies the SOM’s global reach and impact,” said E. Albert Reece, M.D., Ph.D, M.B.A., who is Vice President of Medical Affairs and the John Z. and Akiko Bowers Distinguished Professor and Dean of the University of Maryland School of Medicine. “We look forward to collaborating with our partner institutions in addressing the most critical and urgent global public health issue we currently face today.”
This collaborative multi-trial approach will help ensure the fastest possible progress to determining the best candidate vaccine approach and delivery. The addition of West African testing sites will also ensure that the studies take account of differences between European and West African populations that might affect safety or immune response.
It is hoped that the phase 1 trials might be finished by the end of 2014, after which deployment of the vaccine could be fast-tracked should it prove to be safe and immunogenic.
Dr. Levine and the CVD, which celebrates its 40th anniversary this year, have worked closely with the Ministry of Health in the Republic of Mali in West Africa for nearly two decades, following the Center’s broad success in Chile.
Today, the Republic of Mali in West Africa is an important area of focus for the Center with two components: one focuses on endemic and epidemic infectious diseases, mainly affecting young children. The other component is the Bandiagara Malaria Project, run by the CVD’s Malaria group, which works in a hyper-endemic area of malaria around Bandiagara.
The CVD is particularly devoted to infectious diseases that affect children in less- developed countries. To gather information on the burden of diarrheal diseases, the CVD oversees the global enteric Multicenter study (GEMS). Funded by the Bill & Melinda Gates Foundation, GEMS is the largest, most comprehensive study of the burden and etiology of childhood diarrheal diseases ever conducted in developing country settings. The CVD faculty and staff also consult with international agencies such as the World Health Organization, the agency for International Development, The World Bank, and the GAVI alliance (the Global Alliance for Vaccines and Immunization), as well as with individual governments and health agencies.
Dr. Levine has published over 460 peer reviewed journal articles, is an inventor or co-inventor on many issued patents and is Senior Editor of New Generation Vaccines, a textbook of research vaccinology. He was elected to the Institute of Medicine of the National Academy of Science, the Association of American Physicians, the American Society of Clinical Investigation and the Interurban Clinical Club. He is the recipient of the Albert B. Sabin Gold Medal Award for lifetime achievement in the area of vaccine development and implementation and has also received the Merck-Hilleman Award, the American Society for Microbiology’s premier award for major contributions to pathogenesis, vaccine discovery, vaccine development, and control of vaccine preventable diseases.
The University of Maryland School of Medicine was chartered in 1807 and is the first public medical school in the United States and continues today as an innovative leader in accelerating innovation and discovery in medicine. The School of Medicine is the founding school of the University of Maryland and is an integral part of the 11-campus University System of Maryland. Located on the University of Maryland’s Baltimore campus, the School of Medicine works closely with the University of Maryland Medical Center to provide a research-intensive, academic and clinically based education. With 43 academic departments, centers and institutes and a faculty of more than 3,000 physicians and research scientists plus more than $400 million in extramural funding, the School is regarded as one of the leading biomedical research institutions in the U.S. with top-tier faculty and programs in cancer, brain science, surgery and transplantation, trauma and emergency medicine, vaccine development and human genomics, among other centers of excellence. The School is not only concerned with the health of the citizens of Maryland and the nation, but also has a global vision, with research and treatment facilities in more than 30 countries around the world. http://medschool.umaryland.edu/
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