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Review

The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies

1
Department of Burn, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China
2
Division of Infectious Diseases and Geographic Medicine, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA
3
Center for Excellence in Pulmonary Biology, Department of Pediatrics, Stanford University, Stanford, CA 94305, USA
4
Department of Orthopaedic Surgery, School of Medicine, Stanford University, Stanford, CA 94305, USA
5
Division of Pediatric Infectious Diseases, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USA
6
Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, MN 55905, USA
*
Author to whom correspondence should be addressed.
Theses authors contributed equally to this work.
Academic Editors: Ryszard Międzybrodzki, Nina Chanishvili, Nina V. Tikunova, Jean-Paul Pirnay, Petar Knezevic and Shawna McCallin
Viruses 2021, 13(7), 1268; https://doi.org/10.3390/v13071268
Received: 10 May 2021 / Revised: 23 June 2021 / Accepted: 23 June 2021 / Published: 29 June 2021
(This article belongs to the Special Issue State-of-the-Art Phage Therapy Development in Europe)
Increasing rates of infection by antibiotic resistant bacteria have led to a resurgence of interest in bacteriophage (phage) therapy. Several phage therapy studies in animals and humans have been completed over the last two decades. We conducted a systematic review of safety and toxicity data associated with phage therapy in both animals and humans reported in English language publications from 2008–2021. Overall, 69 publications met our eligibility criteria including 20 animal studies, 35 clinical case reports or case series, and 14 clinical trials. After summarizing safety and toxicity data from these publications, we discuss potential approaches to optimize safety and toxicity monitoring with the therapeutic use of phage moving forward. In our systematic review of the literature, we found some adverse events associated with phage therapy, but serious events were extremely rare. Comprehensive and standardized reporting of potential toxicities associated with phage therapy has generally been lacking in the published literature. Structured safety and tolerability endpoints are necessary when phages are administered as anti-infective therapeutics. View Full-Text
Keywords: phage therapy; clinical trials; animal models; safety and toxicity; immune activation phage therapy; clinical trials; animal models; safety and toxicity; immune activation
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MDPI and ACS Style

Liu, D.; Van Belleghem, J.D.; de Vries, C.R.; Burgener, E.; Chen, Q.; Manasherob, R.; Aronson, J.R.; Amanatullah, D.F.; Tamma, P.D.; Suh, G.A. The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. Viruses 2021, 13, 1268. https://doi.org/10.3390/v13071268

AMA Style

Liu D, Van Belleghem JD, de Vries CR, Burgener E, Chen Q, Manasherob R, Aronson JR, Amanatullah DF, Tamma PD, Suh GA. The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. Viruses. 2021; 13(7):1268. https://doi.org/10.3390/v13071268

Chicago/Turabian Style

Liu, Dan, Jonas D. Van Belleghem, Christiaan R. de Vries, Elizabeth Burgener, Qingquan Chen, Robert Manasherob, Jenny R. Aronson, Derek F. Amanatullah, Pranita D. Tamma, and Gina A. Suh 2021. "The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies" Viruses 13, no. 7: 1268. https://doi.org/10.3390/v13071268

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