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3. A safe insect-based Chikungunya fever vaccine affords rapid and durable protection in cynomolgus macaques

Author

Adam, Awadalkareem, primary, Woolsey, Courtney, additional, Lu, Hannah, additional, Plante, Kenneth S, additional, Wallace, Shannon M, additional, Rodriguez, Leslie, additional, Shinde, Divya Pratik, additional, Cui, Yingjun, additional, Franz, Alexander W.E., additional, Thangamani, Saravanan, additional, Comer, Jason E, additional, Weaver, Scott C, additional, and Wang, Tian, additional

Published
2024
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4. Comparison of Routes of Administration, Frequency, and Duration of Favipiravir Treatment in Mouse and Guinea Pig Models of Ebola Virus Disease.

Author

Johnson, Dylan M., Juelich, Terry, Zhang, Lihong, Smith, Jennifer K., Kalveram, Birte K., Perez, David, Smith, Jeanon, Grimes, Michael R., Garron, Tania, Torres, Maricela, Massey, Shane, Brasel, Trevor, Beasley, David W. C., Freiberg, Alex N., and Comer, Jason E.

Subjects
EBOLA virus disease, EBOLA virus, TREATMENT duration, REGULATORY approval, PRIMATES, GUINEA pigs
Abstract

Favipiravir is a ribonucleoside analogue that has been explored as a therapeutic for the treatment of Ebola Virus Disease (EVD). Promising data from rodent models has informed nonhuman primate trials, as well as evaluation in patients during the 2013–2016 West African EVD outbreak of favipiravir treatment. However, mixed results from these studies hindered regulatory approval of favipiravir for the indication of EVD. This study examined the influence of route of administration, duration of treatment, and treatment schedule of favipiravir in immune competent mouse and guinea pig models using rodent-adapted Zaire ebolavirus (EBOV). A dose of 300 mg/kg/day of favipiravir with an 8-day treatment was found to be fully effective at preventing lethal EVD-like disease in BALB/c mice regardless of route of administration (oral, intraperitoneal, or subcutaneous) or whether it was provided as a once-daily dose or a twice-daily split dose. Preclinical data generated in guinea pigs demonstrates that an 8-day treatment of 300 mg/kg/day of favipiravir reduces mortality following EBOV challenge regardless of route of treatment or duration of treatments for 8, 11, or 15 days. This work supports the future translational development of favipiravir as an EVD therapeutic. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Pathogenic and Apathogenic Strains of Lymphocytic Choriomeningitis Virus Have Distinct Entry and Innate Immune Activation Pathways.

Author

Johnson, Dylan M., Khakhum, Nittaya, Wang, Min, Warner, Nikole L., Jokinen, Jenny D., Comer, Jason E., and Lukashevich, Igor S.

Subjects
LYMPHOCYTIC choriomeningitis virus, INTERLEUKIN-1 receptors, TOLL-like receptors, EPITHELIAL cells, CONFOCAL microscopy
Abstract

Lymphocytic choriomeningitis virus (LCMV) and Lassa virus (LASV) share many genetic and biological features including subtle differences between pathogenic and apathogenic strains. Despite remarkable genetic similarity, the viscerotropic WE strain of LCMV causes a fatal LASV fever-like hepatitis in non-human primates (NHPs) while the mouse-adapted Armstrong (ARM) strain of LCMV is deeply attenuated in NHPs and can vaccinate against LCMV-WE challenge. Here, we demonstrate that internalization of WE is more sensitive to the depletion of membrane cholesterol than ARM infection while ARM infection is more reliant on endosomal acidification. LCMV-ARM induces robust NF-κB and interferon response factor (IRF) activation while LCMV-WE seems to avoid early innate sensing and failed to induce strong NF-κB and IRF responses in dual-reporter monocyte and epithelial cells. Toll-like receptor 2 (TLR-2) signaling appears to play a critical role in NF-κB activation and the silencing of TLR-2 shuts down IL-6 production in ARM but not in WE-infected cells. Pathogenic LCMV-WE infection is poorly recognized in early endosomes and failed to induce TLR-2/Mal-dependent pro-inflammatory cytokines. Following infection, Interleukin-1 receptor-associated kinase 1 (IRAK-1) expression is diminished in LCMV-ARM- but not LCMV-WE-infected cells, which indicates it is likely involved in the LCMV-ARM NF-κB activation. By confocal microscopy, ARM and WE strains have similar intracellular trafficking although LCMV-ARM infection appears to coincide with greater co-localization of early endosome marker EEA1 with TLR-2. Both strains co-localize with Rab-7, a late endosome marker, but the interaction with LCMV-WE seems to be more prolonged. These findings suggest that LCMV-ARM's intracellular trafficking pathway may facilitate interaction with innate immune sensors, which promotes the induction of effective innate and adaptive immune responses. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Pathogenesis of Aerosolized Ebola Virus Variant Makona in Nonhuman Primates

Author

Prasad, Abhishek N, primary, Fenton, Karla A, additional, Agans, Krystle N, additional, Borisevich, Viktoriya, additional, Woolsey, Courtney, additional, Comer, Jason E, additional, Dobias, Natalie S, additional, Peel, Jennifer E, additional, Deer, Daniel J, additional, Geisbert, Joan B, additional, Lawrence, William S, additional, Cross, Robert W, additional, and Geisbert, Thomas W, additional

Published
2023
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10. The Prophylactic and Therapeutic Efficacy of the Broadly Active Antiviral RibonucleosideN4-Hydroxycytidine (EIDD-1931) in a Mouse Model of Lethal Ebola Virus Infection

Author

Bluemling, Gregory R., primary, Mao, Shuli, additional, Natchus, Michael G., additional, Painter, Wendy, additional, Mulangu, Sabue, additional, Lockwood, Mark, additional, De La Rosa, Abel, additional, Brasel, Trevor, additional, Comer, Jason E., additional, Freiberg, Alexander N., additional, Kolykhalov, Alexander A., additional, and Painter, George R., additional

Published
2022
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11. Natural History of Marburg Virus Infection to Support Medical Countermeasure Development

Author

Comer, Jason E., primary, Brasel, Trevor, additional, Massey, Shane, additional, Beasley, David W., additional, Cirimotich, Chris M., additional, Sanford, Daniel C., additional, Chou, Ying-Liang, additional, Niemuth, Nancy A., additional, Novak, Joseph, additional, Sabourin, Carol L., additional, Merchlinsky, Michael, additional, Long, James P., additional, Stavale, Eric J., additional, and Wolfe, Daniel N., additional

Published
2022
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12. Natural history of nonhuman primates after conjunctival exposure to Ebola virus

Author

Cross, Robert W., primary, Prasad, Abhishek N., additional, Woolsey, Courtney B., additional, Agans, Krystle N., additional, Borisevich, Viktoriya, additional, Dobias, Natalie S., additional, Comer, Jason E., additional, Deer, Daniel J., additional, Geisbert, Joan B., additional, Rasmussen, Angela L., additional, Lipkin, W. Ian, additional, Fenton, Karla A., additional, and Geisbert, Thomas W., additional

Published
2021
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13. STAT-1 Knockout Mice as a Model for Wild-Type Sudan Virus (SUDV)

Author

Escaffre, Olivier, primary, Juelich, Terry L., additional, Neef, Natasha, additional, Massey, Shane, additional, Smith, Jeanon, additional, Brasel, Trevor, additional, Smith, Jennifer K., additional, Kalveram, Birte, additional, Zhang, Lihong, additional, Perez, David, additional, Ikegami, Tetsuro, additional, Freiberg, Alexander N., additional, and Comer, Jason E., additional

Published
2021
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14. Natural history of disease in cynomolgus monkeys exposed to Ebola virus Kikwit strain demonstrates the reliability of this non-human primate model for Ebola virus disease

Author

Niemuth, Nancy A., primary, Fallacara, Dawn, additional, Triplett, Cheryl A., additional, Tamrakar, Sanjay M., additional, Rajbhandari, Alisha, additional, Florence, Clint, additional, Ward, Lucy, additional, Griffiths, Anthony, additional, Carrion, Ricardo, additional, Goez-Gazi, Yenny, additional, Alfson, Kendra J., additional, Staples, Hilary M., additional, Brasel, Trevor, additional, Comer, Jason E., additional, Massey, Shane, additional, Smith, Jeanon, additional, Kocsis, Andrew, additional, Lowry, Jake, additional, Johnston, Sara C., additional, Nalca, Aysegul, additional, Goff, Arthur J., additional, Shurtleff, Amy C., additional, Pitt, Margaret L., additional, Trefry, John, additional, and Fay, Michael P., additional

Published
2021
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15. The Fc-mediated effector functions of a potent SARS-CoV-2 neutralizing antibody, SC31, isolated from an early convalescent COVID-19 patient, are essential for the optimal therapeutic efficacy of the antibody

Author

Chan, Conrad E. Z., primary, Seah, Shirley G. K., additional, Chye, De Hoe, additional, Massey, Shane, additional, Torres, Maricela, additional, Lim, Angeline P. C., additional, Wong, Steven K. K., additional, Neo, Jacklyn J. Y., additional, Wong, Pui San, additional, Lim, Jie Hui, additional, Loh, Gary S. L., additional, Wang, Dongling, additional, Boyd-Kirkup, Jerome D., additional, Guan, Siyu, additional, Thakkar, Dipti, additional, Teo, Guo Hui, additional, Purushotorman, Kiren, additional, Hutchinson, Paul E., additional, Young, Barnaby E., additional, Low, Jenny G., additional, MacAry, Paul A., additional, Hentze, Hannes, additional, Prativadibhayankara, Venkateshan S., additional, Ethirajulu, Kantharaj, additional, Comer, Jason E., additional, Tseng, Chien-Te K., additional, Barrett, Alan D. T., additional, Ingram, Piers J., additional, Brasel, Trevor, additional, and Hanson, Brendon John, additional

Published
2021
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16. A Synthetic Peptide CTL Vaccine Targeting Nucleocapsid Confers Protection from SARS-CoV-2 Challenge in Rhesus Macaques

Author

Harris, Paul E., primary, Brasel, Trevor, additional, Massey, Christopher, additional, Herst, C. V., additional, Burkholz, Scott, additional, Lloyd, Peter, additional, Blankenberg, Tikoes, additional, Bey, Thomas M., additional, Carback, Richard, additional, Hodge, Thomas, additional, Ciotlos, Serban, additional, Wang, Lu, additional, Comer, Jason E., additional, and Rubsamen, Reid M., additional

Published
2021
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17. Cell-Type Apoptosis in Lung during SARS-CoV-2 Infection

Author

Liu, Yakun, primary, Garron, Tania M., additional, Chang, Qing, additional, Su, Zhengchen, additional, Zhou, Changcheng, additional, Qiu, Yuan, additional, Gong, Eric C., additional, Zheng, Junying, additional, Yin, Y. Whitney, additional, Ksiazek, Thomas, additional, Brasel, Trevor, additional, Jin, Yang, additional, Boor, Paul, additional, Comer, Jason E., additional, and Gong, Bin, additional

Published
2021
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18. Mucosal Challenge Ferret Models of Ebola Virus Disease

Author

Brasel, Trevor, primary, Comer, Jason E., additional, Massey, Shane, additional, Smith, Jeanon, additional, Smith, Jennifer, additional, Hyde, Matthew, additional, Kocsis, Andrew, additional, Gainey, Melicia, additional, Niemuth, Nancy, additional, Triplett, Cheryl, additional, and Rudge, Thomas, additional

Published
2021
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19. Cell-type apoptosis in lung during SARS-CoV-2 infection

Author

Liu, Yakun, primary, Garron, Tania M., additional, Chang, Qing, additional, Su, Zhengchen, additional, Zhou, Changcheng, additional, Gong, Eric C., additional, Zheng, Junying, additional, Yin, Yw, additional, Ksiazek, Thomas, additional, Brasel, Trevor, additional, Jin, Yang, additional, Boor, Paul, additional, Comer, Jason E., additional, and Gong, Bin, additional

Published
2020
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20. Anthrax

Author

Comer, Jason E., primary and Peterson, Johnny W., additional

Published
2009
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26. Venezuelan equine encephalitis vaccine with rearranged genome resists reversion and protects non-human primates from viremia after aerosol challenge

Author

Tretyakova, Irina, primary, Plante, Kenneth S., additional, Rossi, Shannan L., additional, Lawrence, William S., additional, Peel, Jennifer E., additional, Gudjohnsen, Sif, additional, Wang, Eryu, additional, Mirchandani, Divya, additional, Tibbens, Alexander, additional, Lamichhane, Tek N., additional, Lukashevich, Igor S., additional, Comer, Jason E., additional, Weaver, Scott C., additional, and Pushko, Peter, additional

Published
2020
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31. Modeling Rabbit Responses to Single and Multiple Aerosol Exposures of Bacillus anthracis Spores

Author

Coleman, Margaret E., Marks, Harry M., Bartrand, Timothy A., Donahue, Darrell W., Hines, Stephanie A., Comer, Jason E., and Taft, Sarah C.

Subjects
Aerosols, Spores, Bacterial, Air Pollutants, Inhalation Exposure, Models, Statistical, Risk Assessment, Article, Anthrax, Disease Models, Animal, Bacillus anthracis, Animals, Rabbits, Algorithms, Environmental Monitoring
Abstract

Survival models are developed to predict response and time-to-response for mortality in rabbits following exposures to single or multiple aerosol doses of Bacillus anthracis spores. Hazard function models were developed for a multiple-dose data set to predict the probability of death through specifying functions of dose response and the time between exposure and the time-to-death (TTD). Among the models developed, the best-fitting survival model (baseline model) is an exponential dose-response model with a Weibull TTD distribution. Alternative models assessed use different underlying dose-response functions and use the assumption that, in a multiple-dose scenario, earlier doses affect the hazard functions of each subsequent dose. In addition, published mechanistic models are analyzed and compared with models developed in this article. None of the alternative models that were assessed provided a statistically significant improvement in fit over the baseline model. The general approach utilizes simple empirical data analysis to develop parsimonious models with limited reliance on mechanistic assumptions. The baseline model predicts TTDs consistent with reported results from three independent high-dose rabbit data sets. More accurate survival models depend upon future development of dose-response data sets specifically designed to assess potential multiple-dose effects on response and time-to-response. The process used in this article to develop the best-fitting survival model for exposure of rabbits to multiple aerosol doses of B. anthracis spores should have broad applicability to other host-pathogen systems and dosing schedules because the empirical modeling approach is based upon pathogen-specific empirically-derived parameters.

Published
2017

32. Efficacy of Tilorone Dihydrochloride against Ebola Virus Infection

Author

Ekins, Sean, primary, Lingerfelt, Mary A., additional, Comer, Jason E., additional, Freiberg, Alexander N., additional, Mirsalis, Jon C., additional, O'Loughlin, Kathleen, additional, Harutyunyan, Anush, additional, McFarlane, Claire, additional, Green, Carol E., additional, and Madrid, Peter B., additional

Published
2018
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35. Evaluation of Intravenous Anthrax Immune Globulin for Treatment of Inhalation Anthrax

Author

Mytle, Nutan, primary, Hopkins, Robert J., additional, Malkevich, Nina V., additional, Basu, Subhendu, additional, Meister, Gabriel T., additional, Sanford, Daniel C., additional, Comer, Jason E., additional, Van Zandt, Kristopher E., additional, Al-Ibrahim, Mohamed, additional, Kramer, William G., additional, Howard, Cris, additional, Daczkowski, Nancy, additional, Chakrabarti, Ajoy C., additional, Ionin, Boris, additional, Nabors, Gary S., additional, and Skiadopoulos, Mario H., additional

Published
2013
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36. Achieving Consistent Multiple Daily Low-Dose Bacillus anthracis Spore Inhalation Exposures in the Rabbit Model

Author

NAVAL SURFACE WARFARE CENTER DAHLGREN VA, Barnewall, Roy E, Comer, Jason E, Miller, Brian D, Gutting, Bradford W, Wolfe, Daniel N, Director-Myska, Alison E, Nichols, Tonya L, Taft, Sarah C, NAVAL SURFACE WARFARE CENTER DAHLGREN VA, Barnewall, Roy E, Comer, Jason E, Miller, Brian D, Gutting, Bradford W, Wolfe, Daniel N, Director-Myska, Alison E, Nichols, Tonya L, and Taft, Sarah C

Abstract

Repeated low-level exposures to biological agents could occur before or after the remediation of an environmental release. This is especially true for persistent agents such as B. anthracis spores, the causative agent of anthrax. Studies were conducted to examine aerosol methods needed for consistent daily low aerosol concentrations to deliver a low- dose (less than 106 colony forming units (CFU) of B. anthracis spores) and included a pilot feasibility characterization study, acute exposure study, and a multiple 15 day exposure study. This manuscript focuses on the state-of-the-science aerosol methodologies used to generate and aerosolize consistent daily low aerosol concentrations and resultant low inhalation doses to rabbits. The pilot feasibility characterization study determined that the aerosol system was consistent and capable of producing very low aerosol concentrations. In the acute, single day exposure experiment, targeted inhaled doses of 1x10(2) , 1x10(3) , 1x10(4) , and 1x10(5) CFU were used. In the multiple daily exposure experiment, rabbits were exposed multiple days to targeted inhaled doses of 1x10(2) ,1x10(3) , and 1x 10(4) CFU. In all studies, targeted inhaled doses remained consistent from rabbit-to-rabbit and day- to-day. The aerosol system produced aerosolized spores within the optimal mass median aerodynamic diameter particle size range to reach deep lung alveoli. Consistency of the inhaled dose was aided by monitoring and recording respiratory parameters during the exposure with real-time plethysmography. Overall, the presented results show that the animal aerosol system was stable and highly reproducible between different studies and over multiple exposure days., Published in Frontiers in Cellular And Infection Microbiology, Volume 2, June 2012, Article 71. The original document contains color images.

Published
2012

41. Human Monoclonal Antibody AVP-21D9 to Protective Antigen Reduces Dissemination of the Bacillus anthracis Ames Strain from the Lungs in a Rabbit Model

Author

Peterson, Johnny W., primary, Comer, Jason E., additional, Baze, Wallace B., additional, Noffsinger, David M., additional, Wenglikowski, Autumn, additional, Walberg, Kristin G., additional, Hardcastle, Jason, additional, Pawlik, Jennifer, additional, Bush, Kathryn, additional, Taormina, Joanna, additional, Moen, Scott, additional, Thomas, John, additional, Chatuev, Bagram M., additional, Sower, Laurie, additional, Chopra, Ashok K., additional, Stanberry, Lawrence R., additional, Sawada, Ritsuko, additional, Scholz, Wolfgang W., additional, and Sircar, Jagadish, additional

Published
2007
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43. Human Monoclonal Anti-Protective Antigen Antibody Completely Protects Rabbits and Is Synergistic with Ciprofloxacin in Protecting Mice and Guinea Pigs against Inhalation Anthrax

Author

Peterson, Johnny W., primary, Comer, Jason E., additional, Noffsinger, David M., additional, Wenglikowski, Autumn, additional, Walberg, Kristin G., additional, Chatuev, Bagram M., additional, Chopra, Ashok K., additional, Stanberry, Lawrence R., additional, Kang, Angray S., additional, Scholz, Wolfgang W., additional, and Sircar, Jagadish, additional

Published
2006
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48. Examining the Vector-Host-Pathogen Interface With Quantitative Molecular Tools.

Author

Walker, John M., DeLeo, Frank R., Otto, Michael, Comer, Jason E, Lorange, Ellen A, and Hinnebusch, B Joseph

Abstract

We developed PCR assays to detect and quantitate Yersinia pestis, the bacterial agent of plague, in flea vector and mammalian host tissues. Bacterial numbers in fleas, fleabite sites, and infected lymph nodes were determined using real-time PCR with primers and probes for a gene target on a multi-copy plasmid specific to Y. pestis. Tissue-matched standard curves used to determine absolute bacterial numbers in unknown samples were linear over at least five orders of magnitude. The methods were applied to studies of transmission of Y. pestis by the rat flea Xenopsylla cheopis, but should be generally useful to investigate the transmission dynamics of any arthropod-borne disease. [ABSTRACT FROM AUTHOR]

Published
2008
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50. Development of an Inhalational Bacillus anthracisExposure Therapeutic Model in Cynomolgus Macaques

Author

Henning, Lisa N., Comer, Jason E., Stark, Gregory V., Ray, Bryan D., Tordoff, Kevin P., Knostman, Katherine A. B., and Meister, Gabriel T.

Abstract

ABSTRACTAppropriate animal models are required to test medical countermeasures to bioterrorist threats. To that end, we characterized a nonhuman primate (NHP) inhalational anthrax therapeutic model for use in testing anthrax therapeutic medical countermeasures according to the U.S. Food and Drug Administration Animal Rule. A clinical profile was recorded for each NHP exposed to a lethal dose of Bacillus anthracisAmes spores. Specific diagnostic parameters were detected relatively early in disease progression, i.e., by blood culture (~37 h postchallenge) and the presence of circulating protective antigen (PA) detected by electrochemiluminescence (ECL) ~38 h postchallenge, whereas nonspecific clinical signs of disease, i.e., changes in body temperature, hematologic parameters (ca. 52 to 66 h), and clinical observations, were delayed. To determine whether the presentation of antigenemia (PA in the blood) was an appropriate trigger for therapeutic intervention, a monoclonal antibody specific for PA was administered to 12 additional animals after the circulating levels of PA were detected by ECL. Seventy-five percent of the monoclonal antibody-treated animals survived compared to 17% of the untreated controls, suggesting that intervention at the onset of antigenemia is an appropriate treatment trigger for this model. Moreover, the onset of antigenemia correlated with bacteremia, and NHPs were treated in a therapeutic manner. Interestingly, brain lesions were observed by histopathology in the treated nonsurviving animals, whereas this observation was absent from 90% of the nonsurviving untreated animals. Our results support the use of the cynomolgus macaque as an appropriate therapeutic animal model for assessing the efficacy of medical countermeasures developed against anthrax when administered after a confirmation of infection.

Published
2012
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