Development of an Inhalational Bacillus anthracis Exposure Therapeutic Model in Cynomolgus Macaques

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Published inClinical and Vaccine Immunology Vol. 19; no. 11; pp. 1765 - 1775
Main Authors Henning, Lisa N, Comer, Jason E, Stark, Gregory V, Ray, Bryan D, Tordoff, Kevin P, Knostman, Katherine A B, Meister, Gabriel T
Format Journal Article
LanguageEnglish
Published United States American Society for Microbiology 01.11.2012
Subjects
Animals
Anthrax - diagnosis
Anthrax - pathology
Anthrax - therapy
Antibodies, Bacterial - administration & dosage
Antibodies, Monoclonal - administration & dosage
Antigens, Bacterial - blood
Bacterial Toxins - blood
Biomarkers - blood
Brain - pathology
Clinical Immunology
Disease Models, Animal
Female
Guideline Adherence
Macaca fascicularis
Male
Primate Diseases - diagnosis
Primate Diseases - pathology
Primate Diseases - therapy
Respiratory Tract Infections - diagnosis
Respiratory Tract Infections - pathology
Respiratory Tract Infections - therapy
Survival Analysis
Time Factors
United States
United States Food and Drug Administration
United States
Online AccessGet full text

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Abstract Classifications Services CVI Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue CVI About CVI Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy CVI RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 1556-6811 Online ISSN: 1556-679X Copyright © 2014 by the American Society for Microbiology.   For an alternate route to CVI .asm.org, visit: CVI       
AbstractList ABSTRACT Appropriate 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 anthracis Ames 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.
Classifications Services CVI Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue CVI About CVI Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy CVI RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 1556-6811 Online ISSN: 1556-679X Copyright © 2014 by the American Society for Microbiology.   For an alternate route to CVI .asm.org, visit: CVI       
Appropriate 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 anthracis Ames 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.
Appropriate 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 anthracis Ames 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.
Author Lisa N. Henning
Gabriel T. Meister
Gregory V. Stark
Katherine A. B. Knostman
Jason E. Comer
Bryan D. Ray
Kevin P. Tordoff
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Appropriate animal models are required to test medical countermeasures to bioterrorist threats. To that end, we characterized a nonhuman primate (NHP)...
ABSTRACT Appropriate animal models are required to test medical countermeasures to bioterrorist threats. To that end, we characterized a nonhuman primate (NHP)...
SourceID pubmedcentral
proquest
crossref
pubmed
highwire
SourceType Open Access Repository
Aggregation Database
Index Database
Publisher
StartPage 1765
SubjectTerms Animals
Anthrax - diagnosis
Anthrax - pathology
Anthrax - therapy
Antibodies, Bacterial - administration & dosage
Antibodies, Monoclonal - administration & dosage
Antigens, Bacterial - blood
Bacterial Toxins - blood
Biomarkers - blood
Brain - pathology
Clinical Immunology
Disease Models, Animal
Female
Guideline Adherence
Macaca fascicularis
Male
Primate Diseases - diagnosis
Primate Diseases - pathology
Primate Diseases - therapy
Respiratory Tract Infections - diagnosis
Respiratory Tract Infections - pathology
Respiratory Tract Infections - therapy
Survival Analysis
Time Factors
United States
United States Food and Drug Administration
Title Development of an Inhalational Bacillus anthracis Exposure Therapeutic Model in Cynomolgus Macaques
URI http://cvi.asm.org/content/19/11/1765.abstract
https://www.ncbi.nlm.nih.gov/pubmed/22956657
https://search.proquest.com/docview/1115529843
https://pubmed.ncbi.nlm.nih.gov/PMC3491545
Volume 19
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