SPECIAL NOTICE
B -- Melioidosis Animal Model Treatment Report
- Notice Date
- 7/30/2009
- Notice Type
- Special Notice
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 00HCVHEE-2009-72407
- Archive Date
- 8/7/2009
- Point of Contact
- Linda M Young, Phone: (770) 488-2655
- E-Mail Address
-
lml3@cdc.gov
(lml3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Colorado State University, 5148 Blue Sky Drive, Loveland, CO 80538, for Melioidosis Animal Model Treatment Report. Statement of Work is as follows: Background & Need: The Bacterial Zoonoses Branch (BZB) in the Division of Foodborne, Bacterial and Mycotic Diseases is responsible for the development of bioterrorism preparedness plans for several select agents and the diseases that they cause, including melioidosis, caused by Burkholderia pseudomallei, an agent not found naturally in the United States. Because of BZB's role, it is an important part of the nation's defense against bioterrorism or biowarfare. Healthy People 2010 Goals for People Prepared for Emerging Threats states that we will "Support and strengthen human and technological epidemiologic resources to prevent, investigate, mitigate, and control current, emerging, and new public health threats and to conduct research and development that lead to interventions for such threats." Currently, we have little US-based expertise in the laboratory evaluation of B. pseudomallei as a pathogen and no clinicians known to have cared for more than a single rare case in a traveler. The medical literature contains antimicrobial agents of choice that do not have approval for use in melioidosis by the Food and Drug Administration; given the potential for use of Burkholderia pseudomallei in an exposure event, FDA approval of treatment regimens melioidosis is necessary for improving response activities. In order to best evaluate potential agents for treatment for melioidosis for FDA approval under the animal rule, appropriate animal models must be developed. In addition, treatment guidelines may be impacted by different routes of acquisition/infection which may affect infectious dose and disease progression and severity. Burkholderia pseudomallei infects a wide range of animals (Choy et al., 2000; Sprague & Neubauer, 2004) and consequently animal model development is readily attainable. Human melioidosis is characterized by acute and chronic phase disease, and occurs more frequently in individuals with underlying risk factors, e.g. diabetes (Cheng & Currie, 2005; Wiersinga et al., 2006). Over the years, animal models have been developed that mimic disease manifestations (e.g. chronic vs. acute in different mouse strains) and risk factors (e.g. diabetic rats)[reviewed in (Titball et al., 2008)]. Depending on strain, routes of inoculation and dose, the host species differ widely in both susceptibility and pathogenesis of disease. It has also been reported that B. pseudomallei animal and human isolates from Malaysia exhibit different phenotypic characteristics (Lee et al., 2007). It is therefore not yet clear which of the small animal models accurately reflect human disease and it is quite possible that different animal species and strains may be necessary for mimicking different aspects of human melioidosis. Humanized mice may more accurately reflect human melioidosis disease manifestations and should thus be exploited for melioidosis model development. Larger animal models have not yet been fully developed although it is quite clear that non-human primate models may be central for vaccine and therapeutic development and efficacy studies. Alternatively, natural hosts such as goats may be suitable for development of large animal models. BZB requires US-based research expertise in B. pseudomallei and its resistance mechanisms to assist in developing a plan to identify appropriate animal models for use in testing prioritized antimicrobials and antimicrobial combinations and adjunctive therapy for FDA approval for treatment melioidosis under the animal rule. Project Objectives: BZB requires development of a plan to identify appropriate animal models for testing the clinically recommended antimicrobials or antimicrobial combinations in conjunction with adjunctive therapy in order to move toward FDA approval of these anticmicrobials for the treatment of melioidosis under the animal rule. The period of performance for this order is one year from date of award. Scope of Work: The requested plan should: 1. Provide a description of prior animal models of melioidosis addressing acute, latent, and chronic melioidosis and re-activation of melioidosis, 2. Describe previous animal models addressing potential routes of acquisition of B pseudomallei infection, such as inhalation, ingestion, inoculation 3. Describe study designs for additional testing melioidosis disease manifestations (acute, latent, chronic, and re-activation) in animal models. 4. Describe study designs to further address potential routes of acquisition and their outcomes in animal models 5. Provide a description of current murine models and the effect of various mouse strains on melioidosis disease manifestations and pathogenesis. 6. Describe the use of humanized mice as a possible model for human melioidosis. 7. Describe previous and potential use of alternate small animal models (hamsters, rats) and their application for testing of prioritized antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for approval under the FDA animal rule. 8. Describe previous and potential use of large animal models (non-human primates, goats) and their application for testing of prioritized antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule. 9. Describe how animal model data will be used to evaluate current treatment recommendations. 10. Delineate a research plan for testing prioritized antimicrobial agents and combinations adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule. Detailed technical requirements: The requested plan should: 1. Provide a description of previous animal models of melioidosis addressing acute, latent, and chronic melioidosis and re-activation of melioidosis. Papers in the medical literature describing clinical presentations of melioidosis (acute, latent, chronic, and re-activation) as well as addressing animal models that have been used to study these manifestations should be described. 2. Describe previous animal models addressing potential routes of acquisition of B pseudomallei infection, such as inhalation, ingestion, and inoculation Papers in the medical literature describing routes of acquisition of melioidosis (inhalation, ingestion, and inoculation) as well as addressing animal models that have been used to study various routes of acquisition should be described. 3. Describe study designs for additional research into melioidosis disease presentations (acute, latent, chronic, and re-activation) in animal models. Based on review of prior animal models of melioidosis, describe potential study designs using animal models that could be utilized to further study melioidosis disease presentation, and describe necessary interactions with FDA in determining the appropriateness if identified animal models.. 4. Describe study designs to further address potential routes of acquisition and their outcomes in animal models. Based on review of prior animal models of melioidosis, describe potential study designs using animal models that could be utilized to further study routes of acquisition of B pseudomallei infection and their impact on disease presentation and manifestations, and describe necessary interactions with FDA in determining the appropriateness if identified animal models. 5. Provide a description of current murine models and the effect of various mouse strains on melioidosis disease manifestations and pathogenesis. Multiple papers in the medical and microbiological literature addressing various murine models and the disease manifestations and pathogenesis observed with various mouse strain studied should be used to describe the variation in disease manifestations seen with various murine models. 6. Describe the use of humanized mice as a possible model for human melioidosis. Papers in the medical and microbiological literature addressing use of humanized mice in modeling human disease should be used, and a description of humanized mice and their use in further studies and their applicability to modeling human melioidosis should be developed. 7. Describe previous and potential use of alternate small animal models (hamsters, rats) and their application for testing of antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for approval under the FDA animal rule. Papers in the medical and microbiological literature addressing use of alternate small animals in modeling human disease should be used, and a description of potential use of alternate small animals in melioidosis studies and their applicability to testing of antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for approval under the FDA animal rule should be described. 8. Describe previous and potential use of large animal models (non-human primates, goats) and their application for testing of prioritized antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule. Papers in the medical and microbiological literature addressing use of large animal models in modeling human disease should be used, and a description of potential use of large animal models in melioidosis studies and their applicability to testing of antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for approval under the FDA animal rule should be described. 9. Describe how animal model data will be used to evaluate current treatment recommendations. Should describe how previous and future animal studies can most effectively be used to evaluate and demonstrate the efficacy of current treatment recommendations. 10. Delineate a research plan for testing prioritized antimicrobial agents and combinations adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule. This plan should provide required steps and a detailed plan for testing under the FDA's animal rule that could be adapted to the appropriate animal model(s) as determined by animal modeling studies. Steps required for this work include: 1. Literature review of previous animal models of melioidosis addressing acute, latent, and chronic melioidosis and re-activation of melioidosis and description of animal models and findings from previous animal models that have been used to study these manifestations.. 2. Literature review of previous animal models addressing potential routes of acquisition of B pseudomallei infection, such as inhalation, ingestion, and inoculation and description of animal models and findings from previous animal models addressing routes of B pseudomallei acquisition. 3. Description of study designs for additional research into melioidosis disease presentations (acute, latent, chronic, and re-activation) in animal models that are appropriate in order to better characterized disease presentation. 4. Description of study designs for additional research into melioidosis to further address potential routes of acquisition and their outcomes in animal models. 5. Literature review and description of current murine models and the effect of various mouse strains on melioidosis disease manifestations and pathogenesis. 6. Literature review of the use of humanized mice as models for human disease and melioidosis and development of a description of humanized mice and their use studies of melioidosis and their applicability to modeling human melioidosis. 7. Literature review and description of previous and potential use of alternate small animal models (hamsters, rats) and their application for testing of antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for approval under the FDA animal rule. 8. Literature review and description of previous and potential use of large animal models (non-human primates, goats) and their application for testing of prioritized antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule. 9. Description of how previous and future animal studies can most effectively be used to evaluate and demonstrate the efficacy of current treatment recommendations. 10. Development and delineation of a research plan for testing prioritized antimicrobial agents and combinations adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule that can be adapted to appropriate animal models. Deliverables 1. Description of previous animal models of melioidosis addressing acute, latent, and chronic melioidosis and re-activation of melioidosis. Should describe of animal models and findings from previous animal models that have been used to study these manifestations and be a minor portion of the time and effort. 2. Description of animal models and findings from previous animal models addressing routes of B pseudomallei acquisition such as inhalation, ingestion, and inoculation. Should describe previous models and findings in the literature and be a minor portion of time and effort. 3. Description of study designs for additional research into melioidosis disease presentations (acute, latent, chronic, and re-activation) in animal models that are appropriate in order to better characterized disease presentation. Should be a comprehensive description of various study designs and animal models and be a main portion of time and effort. 4. Description of study designs for additional research into melioidosis to further address potential routes of acquisition and their outcomes in animal models that are appropriate.. Should describe animal models that will help to characterize path physiologic processes related to various routes of acquisition and be a main portion of time and effort. 5. Description of current murine models and the effect of various mouse strains on melioidosis disease manifestations and pathogenesis. Should describe various models based on review of pertinent literature and be a main portion of the time and effort 6. Description of description of humanized mice and their use studies of melioidosis and their applicability to modeling human melioidosis.. Should describe use of humanized mice and applicability to melioidosis and be a main portion of the time and effort. 7. Description of previous and potential use of alternate small animal models (hamsters, rats) and their application for testing of prioritized antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for approval under the FDA animal rule. Should outline appropriate alternate small animal models for use in testing prioritized agents under the FDA animal rule.. 8. Description of previous and potential use of large animal models (non-human primates, goats) and their application for testing of prioritized antimicrobial agents and combinations and adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule. Should outline appropriate large animal models for use in testing prioritized agents under the FDA animal rule 9. Description of how previous and future animal studies can most effectively be used to evaluate and demonstrate the efficacy of current treatment recommendations. Should describe in detail how previous and future animal studies can most effectively be used to evaluate and demonstate efficacy of current treatment recommendation as background for testing under the FDA's animal rule, actively engaging the FDA to determine the appropriateness of these animal models. 10. Delineation of a research plan for testing prioritized antimicrobial agents and combinations adjunctive therapy for treatment of melioidosis for FDA approval under the animal rule that can be adapted to appropriate animal models. Should delineate a proposal for testing of the prioritized list of agents in a complete fashion that can be adapted to an appropriate animal model, ready for grant submission. Reporting Schedule: Reports in the deliverables schedule may be delivered electronically. Special Considerations: None References: 1. Cheng, A. C. & Currie, B. J. (2005). Melioidosis: epidemiology, pathophysiology, and management. Clin Microbiol Rev 18, 383-416. 2. Choy, J. L., Mayo, M., Janmaat, A. & Currie, B. J. (2000). Animal melioidosis in Australia. Acta Trop 74, 153-158. 3. Lee, S. H., Chong, C. E., Lim, B. S., Chai, S. J., Sam, K. K., Mohamed, R. & Nathan, S. (2007). Burkholderia pseudomallei animal and human isolates from Malaysia exhibit different phenotypic characteristics. Diagn Microbiol Infect Dis 58, 263-270. 4. Sprague, L. D. & Neubauer, H. (2004). Melioidosis in animals: a review on epizootiology, diagnosis and clinical presentation. J Vet Med B Infect Dis Vet Public Health 51, 305-320. 5. Titball, R. W., Russell, P., Cuccui, J. & other authors (2008). Burkholderia pseudomallei: animal models of infection. Trans R Soc Trop Med Hyg 102 Suppl 1, S111-116. 6. Wiersinga, W. J., van der Poll, T., White, N. J., Day, N. P. & Peacock, S. J. (2006). Melioidosis: insights into the pathogenicity of Burkholderia pseudomallei. Nat Rev Microbiol 4, 272-282. 7. Wuthiekanun V, Peacock SJ. Management of melioidosis. Expert Rev Anti Infect Ther 2006;4:445-55. 8. White NJ. Melioidosis. Lancet 2003;361:1715-22. Deliverables Schedule Item Description, Quantity, Delivery Date Description of previous animal models of melioidosis addressing disease presentations 1 copy 1 month Description of previous animal models of melioidosis addressing routes of acquisition. 1 copy 2 month Description of study designs for additional research into melioidosis disease presentation using animal models 1 copy 4 month Description of study designs for additional research into routes of acquisition of melioidosis using animal models 1 copy 5 month Description of current murine models and the effect of various mouse strains on melioidosis disease manifestations and pathogenesis 1 copy 6 month Description of humanized mice and their use in studies of melioidosis and applicability to modeling human melioidosis 1 copy 7 month Description of previous and potential use of alternate small animals for testing of agents under the FDA animal rule 1 copy 8 month Description of previous and potential use of large animal models for testing of agents under the FDA animal rule 1 copy 9 month Description of how previous and future animal studies can most effectively be used to evaluate and demonstrate the efficacy of current treatment recommendations 1 copy 10 month Delineation for research plan for testing of prioritized antimicrobial agents and combinations and adjunctive therapy under the FDA animal rule 1 copy 11 month Quarterly Progress Reports 1 copy Due Quarterly: beginning 90 days after date of award. Final Evaluation Report 1 copy Due within 30 days of award completion Please note that vendor must be US-based. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/00HCVHEE-2009-72407/listing.html)
- Place of Performance
- Address: 5148 Blue Sky Drive, Loveland, Colorado, 80538, United States
- Zip Code: 80538
- Zip Code: 80538
- Record
- SN01893980-W 20090801/090731001313-15942a967cac8495aab559c688aa5a74 (fbodaily.com)
- Source
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