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An objective approach for Burkholderia pseudomallei strain selection as challenge material for medical countermeasures efficacy testing.

Abstract

Burkholderia pseudomallei is the causative agent of melioidosis, a rare disease of biodefense concern with high mortality and extreme difficulty in treatment. No human vaccines are available that protect against B. pseudomallei infection, and with the current limitations of antibiotic treatment, the development of new preventative and therapeutic interventions is crucial. Although clinical trials could be used to test the efficacy of new medical countermeasures (MCMs), the high mortality rates associated with melioidosis raises significant ethical issues concerning treating individuals with new compounds with unknown efficacies. The US Food and Drug Administration (FDA) has formulated a set of guidelines for the licensure of new MCMs to treat diseases in which it would be unethical to test the efficacy of these drugs in humans. The FDA "Animal Rule" 21 CFR 314 calls for consistent, well-characterized B. pseudomallei strains to be used as challenge material in animal models. In order to facilitate the efficacy testing of new MCMs for melioidosis using animal models, we intend to develop a well-characterized panel of strains for use. This panel will comprise of strains that were isolated from human cases, have a low passage history, are virulent in animal models, and are well-characterized phenotypically and genotypically. We have reviewed published and unpublished data on various B. pseudomallei strains to establish an objective method for selecting the strains to be included in the panel of B. pseudomallei strains with attention to five categories: animal infection models, genetic characterization, clinical and passage history, and availability of the strain to the research community. We identified 109 strains with data in at least one of the five categories, scored each strain based on the gathered data and identified six strains as candidate for a B. pseudomallei strain panel.

Authors+Show Affiliations

Battelle, Columbus OH, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

23057010

Citation

Van Zandt, Kristopher E., et al. "An Objective Approach for Burkholderia Pseudomallei Strain Selection as Challenge Material for Medical Countermeasures Efficacy Testing." Frontiers in Cellular and Infection Microbiology, vol. 2, 2012, p. 120.
Van Zandt KE, Tuanyok A, Keim PS, et al. An objective approach for Burkholderia pseudomallei strain selection as challenge material for medical countermeasures efficacy testing. Front Cell Infect Microbiol. 2012;2:120.
Van Zandt, K. E., Tuanyok, A., Keim, P. S., Warren, R. L., & Gelhaus, H. C. (2012). An objective approach for Burkholderia pseudomallei strain selection as challenge material for medical countermeasures efficacy testing. Frontiers in Cellular and Infection Microbiology, 2, 120. https://doi.org/10.3389/fcimb.2012.00120
Van Zandt KE, et al. An Objective Approach for Burkholderia Pseudomallei Strain Selection as Challenge Material for Medical Countermeasures Efficacy Testing. Front Cell Infect Microbiol. 2012;2:120. PubMed PMID: 23057010.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An objective approach for Burkholderia pseudomallei strain selection as challenge material for medical countermeasures efficacy testing. AU - Van Zandt,Kristopher E, AU - Tuanyok,Apichai, AU - Keim,Paul S, AU - Warren,Richard L, AU - Gelhaus,H Carl, Y1 - 2012/09/26/ PY - 2012/06/05/received PY - 2012/08/29/accepted PY - 2012/10/12/entrez PY - 2012/10/12/pubmed PY - 2012/10/12/medline KW - aerosol KW - animal models KW - biodefense KW - genome KW - passage history KW - pseudomallei KW - sequencing KW - virulence SP - 120 EP - 120 JF - Frontiers in cellular and infection microbiology JO - Front Cell Infect Microbiol VL - 2 N2 - Burkholderia pseudomallei is the causative agent of melioidosis, a rare disease of biodefense concern with high mortality and extreme difficulty in treatment. No human vaccines are available that protect against B. pseudomallei infection, and with the current limitations of antibiotic treatment, the development of new preventative and therapeutic interventions is crucial. Although clinical trials could be used to test the efficacy of new medical countermeasures (MCMs), the high mortality rates associated with melioidosis raises significant ethical issues concerning treating individuals with new compounds with unknown efficacies. The US Food and Drug Administration (FDA) has formulated a set of guidelines for the licensure of new MCMs to treat diseases in which it would be unethical to test the efficacy of these drugs in humans. The FDA "Animal Rule" 21 CFR 314 calls for consistent, well-characterized B. pseudomallei strains to be used as challenge material in animal models. In order to facilitate the efficacy testing of new MCMs for melioidosis using animal models, we intend to develop a well-characterized panel of strains for use. This panel will comprise of strains that were isolated from human cases, have a low passage history, are virulent in animal models, and are well-characterized phenotypically and genotypically. We have reviewed published and unpublished data on various B. pseudomallei strains to establish an objective method for selecting the strains to be included in the panel of B. pseudomallei strains with attention to five categories: animal infection models, genetic characterization, clinical and passage history, and availability of the strain to the research community. We identified 109 strains with data in at least one of the five categories, scored each strain based on the gathered data and identified six strains as candidate for a B. pseudomallei strain panel. SN - 2235-2988 UR - https://www.unboundmedicine.com/medline/citation/23057010/An_objective_approach_for_Burkholderia_pseudomallei_strain_selection_as_challenge_material_for_medical_countermeasures_efficacy_testing_ L2 - https://doi.org/10.3389/fcimb.2012.00120 DB - PRIME DP - Unbound Medicine ER -