July 06, 2016
Trial Will Examine Safety and Efficacy in Setting Where Malaria Is Common
Malaria is one of the world’s deadliest diseases: it infects hundreds of millions of people every year, and kills about half a million, most of them under five years of age.
There is no vaccine. Experts agree that an effective vaccine could transform how we deal with the disease, potentially saving millions of lives. Now, researchers at the University of Maryland School of Medicine (UM SOM) are testing a malaria vaccine that has shown success in early tests.
They recently started a Phase 1 trial of the vaccine to test its safety and efficacy, in a place where malaria is common.
The trial, which will test the PfSPZ Vaccine, began last month in Burkina Faso, West Africa. The study is a joint project of the country’s National Center for Malaria Research and Training and the University of Maryland School of Medicine’s Institute for Global Health (IGH).
The trial is a follow-up to successful clinical trials conducted at the University of Maryland School of Medicine’s Center for Vaccine Development in Baltimore. A study by the same group of researchers, completed earlier this year, found that the vaccine protected against malaria infection up to a year after vaccination.
The vaccine was originally developed by Sanaria, a biotech company based in Rockville, Maryland. The current trial is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). (Grant number: NIH U01AI112367)
“This trial will tell us a lot about how the vaccine works on the ground, in a place where malaria is a real problem,” said Matthew B. Laurens, MD, MPH, Associate Professor of Pediatrics at the UM SOM and IGH, who is co-leading the study. “If the vaccine can work here, it has the potential to help reduce the terrible harm malaria does around the world.” Dr. Laurens is director of the International Clinical Trials Unit, in the IGH Division of Malaria Research.
Christopher Plowe, MD, MPH, Professor of Medicine, of Microbiology and Immunology, and of Epidemiology and Public Health, as well as director of IGH, is also co-leading the trial. The study will be the first to test the highest dose of the vaccine given so far, and will be one of the first to evaluate how it works against naturally-transmitted malaria in Africa. The higher dose is needed to overcome pre-existing immunity to malaria in regions where the disease is common. Preliminary testing suggests that it will be very effective at this dose.
Development of a malaria vaccine is crucial for malaria control and elimination. A vaccine would complement existing tools against malaria, such as insecticide-treated bed nets, post-infection medical treatment, and preventive therapy in pregnant women. “By itself, a vaccine won’t end malaria,” said Dr. Plowe. “But an effective vaccine could get us there a lot faster.”
The trial will enroll 112 adults, and will continue through 2018. It will examine four different doses of the vaccine to see if they are safe. If no safety concerns are identified, an additional 80 adults will receive the highest dose to examine both its safety and efficacy against naturally-transmitted malaria over two years.
“This trial shows once again that our researchers are doing work that has the potential to change the world,” said UM SOM Dean E. Albert Reece, MD, PhD, MBA, who is also the vice president for Medical Affairs, University of Maryland, and the John Z. and Akiko K. Bowers Distinguished Professor. “Malaria is a worldwide scourge, and is especially damaging for the poorest countries. If we can reduce its effects through this vaccine, we could have a tremendous impact.”
About the University of Maryland School of Medicine
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 and Medical System 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 presence, with research and treatment facilities in more than 35 countries around the world.
http://medschool.umaryland.edu/
About the Center for Vaccine Development
The Center for Vaccine Development (CVD) at the University of Maryland School of Medicine works nationally and internationally to prevent disease and save lives through the development and delivery of vaccines. As an academic research center, CVD is engaged in the full range of vaccinology, including basic science research, vaccine development, pre-clinical and clinical evaluation, and post-marketing field studies.
http://medschool.umaryland.edu/cvd/
Contact
Office of Public Affairs
655 West Baltimore Street
Bressler Research Building 14-002
Baltimore, Maryland 21201-1559
Contact Media Relations
(410) 706-5260
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