GALVESTON, TX– The University of Texas Medical branch in Galveston has been awarded an agreement up to nearly $25 million from the U.S. Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) (within the Administration for Strategic Preparedness and Response (ASPR)), for their efforts in the collaborative development of vaccines to protect against infection by Ebola (EBOV), Sudan (SUDV), Marburg (MARV), and Lassa (LASV) viruses. This project award was executed via Other Transaction Authority (OTA) to UTMB through the Medical CBRN Defense Consortium (MCDC).
The three-year base Project Agreement, an award of $13.5 million, covers development of the filovirus vaccines through completion of a Phase 1 trial, which will be run by the Sealy Institute of Vaccine Sciences at UTMB. UTMB will partner with Moderna Inc., to apply their robust and flexible mRNA platform to the design, manufacture, and testing of candidate vaccines. The project could also receive up to an additional $11.1 million if options are exercised for additional tasks to model alternative routes of vaccine administration or infection for each potential vaccine.
UTMB researcher Dr. Alexander Bukreyev will lead the project as Principal Investigator with co-investigators Dr. Thomas Geisbert and Dr. Richard Rupp to conduct preclinical evaluation, non-clinical testing, and human clinical trials for the mRNA vaccine candidates developed by Moderna (Dr. Andrea Carfi) in collaboration with UTMB (Dr. Alexander Bukreyev).
Currently, there are no U.S. Food and Drug Administration (FDA) approved mRNA vaccines for SUDV, MARV, or LASV, and a single vaccine approved for the prevention of EBOV. The highly pathogenic filoviruses EBOV, SUDV, and MARV cause sporadic outbreaks of severe human diseases, mostly in Central and West sub-Saharan Africa. The disease syndrome caused by these viruses is characterized by fever, malaise, myalgia, hemorrhage, and death, with case fatality rates ranging between 25% and 90%. The arenavirus LASV, also endemic in parts of West Africa, can progress to hemorrhage, vomiting, intense pain, and respiratory distress in up to 20% of cases, ultimately leading to death. The high mortality rate and the potential use of these viruses as an agent of bioterrorism remains a risk that necessitates an urgent development of a vaccine. The development of these prototype vaccines, funded in part by The Medical CBRN Defense Consortium (MCDC), will shorten the timelines for emergency response to biological threat outbreaks and prevent or minimize the impact of these threats to military personnel.