OMAHA, Neb — In partnership with the Liberian government, the National Institute of Allergy and Infectious Diseases (NIAID) 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.
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 trial will be led by co-principal investigators Richard T. Davey, Jr., M.D., deputy clinical director of NIAID’s Division of Intramural Research, and Moses Massaquoi, M.D., National Chair for Case Management at the Ebola Incident Management System in Monrovia.
“This is really a very important study with an innovative approach,” said Dr. Kalil, who has been involved in the design of the study with Dr. Kratochvil. “We must scientifically and rigorously evaluate the experimental treatments that have been given to date to determine what is safe and effective to our patients. We will find out what is working and what is not while the clinical trial is ongoing and adapt the study based on patients’ clinical response.”