TY - JOUR T1 - Development of a Well-Characterized Cynomolgus Macaque Model of Sudan Virus Disease for Support of Product Development JF - bioRxiv DO - 10.1101/2022.05.04.490569 SP - 2022.05.04.490569 AU - Kendra J. Alfson AU - Yenny Goez-Gazi AU - Michal Gazi AU - Ying-Liang Chou AU - Nancy A. Niemuth AU - Marc E. Mattix AU - Hilary Staples AU - Benjamin Klaffke AU - Gloria F. Rodriguez AU - Priscilla Escareno AU - Carmen Bartley AU - Anysha Ticer AU - Elizabeth A. Clemmons AU - John W. Dutton III AU - Anthony Griffiths AU - Gabe T. Meister AU - Daniel C. Sanford AU - Chris M. Cirimotich AU - Ricardo Carrion, Jr Y1 - 2022/01/01 UR - http://biorxiv.org/content/early/2022/05/05/2022.05.04.490569.abstract N2 - The primary objective of this study was to characterize the disease course in cynomolgus macaques exposed to Sudan virus (SUDV), to determine if infection in this species is an appropriate model for the evaluation of filovirus countermeasures under the FDA Animal Rule. Sudan virus causes Sudan virus disease (SVD), with an average case fatality rate of approximately 50%, and while research is ongoing, presently there are no approved SUDV vaccines or therapies. Well characterized animal models are crucial for further developing and evaluating countermeasures for SUDV. Twenty (20) cynomolgus macaques were exposed intramuscularly to either SUDV or sterile phosphate buffered saline; 10 SUDV-exposed animals were euthanized on schedule to characterize pathology at defined durations post-exposure and 8 SUDV-exposed animals were not part of the scheduled euthanasia cohort. Survival was assessed, along with clinical observations, body weights, body temperatures, hematology, clinical chemistry, coagulation, viral load (serum and tissues), macroscopic observations, and histopathology. There were statistically significant differences between SUDV-exposed animals and mock-exposed animals for 26 parameters, including telemetry body temperature, clinical chemistry parameters, hematology parameters, activated partial thromboplastin time, serum viremia, and biomarkers that characterize the disease course of SUDV in cynomolgus macaques.Competing Interest StatementThe authors have declared no competing interest. ER -