UNMC/Nebraska Medicine to be part of Liberia-U.S. clinical research partnership to test Ebola treatments
In partnership with the Liberian government, the National Institute of Allergy and Infectious Diseases (NIAID) today launched a clinical trial to obtain safety and efficacy data on the investigational drug ZMapp as a treatment for Ebola virus disease. The study, which will be conducted in Liberia and the United States, is a randomized controlled trial enrolling adults and children with known Ebola virus infection.
The University of Nebraska Medical Center expects to receive approval of the study in a few weeks. The study is currently being reviewed by the Institutional Review Board, which also monitors biomedical research involving humans. Other sites expected to receive approval are Walter Reed National Military Medical Center in Bethesda, Md. and Emory University Hospital in Atlanta.
Treatment centers in Monrovia, Liberia, will include the ELWA 2 Ebola treatment unit and the Monrovia Medical Unit – staffed by the Commissioned Corps of the U.S. Public Health Service. The NIH Clinical Center in Bethesda, Maryland will serve as a treatment center in the U.S.
“Although ZMapp has been used to treat several Ebola-infected patients in recent months, we cannot determine if the drug actually benefitted those patients because it was not administered within the context of a clinical trial,” said Anthony S. Fauci, M.D., director of the NIAID, at the National Institutes of Health (NIH). “This clinical trial will help us determine if ZMapp and other treatments are safe and effective for use in the current devastating outbreak in West Africa as well as in future outbreaks.”
ZMapp, developed by Mapp Biopharmaceutical Inc., based in San Diego, is composed of three different proteins called monoclonal antibodies. ZMapp is designed to prevent the progression of Ebola virus disease within the body by targeting the main surface protein of the Ebola virus. The antibodies comprising ZMapp are produced in tobacco plants specially bioengineered to produce large quantities of these proteins.
“Our Biocontainment Unit research team has been actively involved in the development of this research protocol and looks forward to participating in the implementation of the research here in Nebraska,” said Christopher Kratochvil, M.D., UNMC associate vice chancellor for clinical research and vice president for research, Nebraska Medicine. “The invitation to participate in this research project once again recognizes the world-class facilities at Nebraska Medicine as well as the expertise of the researchers and staff of the Nebraska Biocontainment Unit.”
Studies in nonhuman primates demonstrated that ZMapp has strong antiviral activity and rescued the animals from death as late as five days after infection with Zaire Ebola virus. The drug has not yet been tested in human clinical trials, but was administered under emergency use authorization to nine infected patients in Africa, the United States, and Western Europe.
Source: University of Nebraska Medical Center