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

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 associ...

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Main Authors: Dan Liu, Jonas D. Van Belleghem, Christiaan R. de Vries, Elizabeth Burgener, Qingquan Chen, Robert Manasherob, Jenny R. Aronson, Derek F. Amanatullah, Pranita D. Tamma, Gina A. Suh
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Language:English
Published: MDPI AG 2021-06-01
Series:Viruses
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Online Access:https://www.mdpi.com/1999-4915/13/7/1268
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author Dan Liu
Jonas D. Van Belleghem
Christiaan R. de Vries
Elizabeth Burgener
Qingquan Chen
Robert Manasherob
Jenny R. Aronson
Derek F. Amanatullah
Pranita D. Tamma
Gina A. Suh
author_facet Dan Liu
Jonas D. Van Belleghem
Christiaan R. de Vries
Elizabeth Burgener
Qingquan Chen
Robert Manasherob
Jenny R. Aronson
Derek F. Amanatullah
Pranita D. Tamma
Gina A. Suh
author_sort Dan Liu
collection DOAJ
description 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.
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spelling doaj.art-377fbfc282f7492f986775bfeca290b02023-11-22T02:13:30ZengMDPI AGViruses1999-49152021-06-01137126810.3390/v13071268The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical StudiesDan Liu0Jonas D. Van Belleghem1Christiaan R. de Vries2Elizabeth Burgener3Qingquan Chen4Robert Manasherob5Jenny R. Aronson6Derek F. Amanatullah7Pranita D. Tamma8Gina A. Suh9Department of Burn, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, ChinaDivision of Infectious Diseases and Geographic Medicine, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USADivision of Infectious Diseases and Geographic Medicine, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USACenter for Excellence in Pulmonary Biology, Department of Pediatrics, Stanford University, Stanford, CA 94305, USADivision of Infectious Diseases and Geographic Medicine, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USADepartment of Orthopaedic Surgery, School of Medicine, Stanford University, Stanford, CA 94305, USADivision of Infectious Diseases and Geographic Medicine, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USADepartment of Orthopaedic Surgery, School of Medicine, Stanford University, Stanford, CA 94305, USADivision of Pediatric Infectious Diseases, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD 21287, USADivision of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, MN 55905, USAIncreasing 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.https://www.mdpi.com/1999-4915/13/7/1268phage therapyclinical trialsanimal modelssafety and toxicityimmune activation
spellingShingle Dan Liu
Jonas D. Van Belleghem
Christiaan R. de Vries
Elizabeth Burgener
Qingquan Chen
Robert Manasherob
Jenny R. Aronson
Derek F. Amanatullah
Pranita D. Tamma
Gina A. Suh
The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies
Viruses
phage therapy
clinical trials
animal models
safety and toxicity
immune activation
title The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies
title_full The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies
title_fullStr The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies
title_full_unstemmed The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies
title_short The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies
title_sort safety and toxicity of phage therapy a review of animal and clinical studies
topic phage therapy
clinical trials
animal models
safety and toxicity
immune activation
url https://www.mdpi.com/1999-4915/13/7/1268
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