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FBO DAILY ISSUE OF JULY 31, 2008 FBO #2439
SPECIAL NOTICE

A -- Development of Transgenic Plant System for the High Level Expression of Outer-Surface Protien A (OspA)

Notice Date

7/29/2008
 

Notice Type

Special Notice
 

NAICS

541711 — Research and Development in Biotechnology
 

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

00HCVHCC-2008-59514
 

Archive Date

8/13/2008
 

Point of Contact

Linda M Young,, Phone: (770) 488-2655
 

E-Mail Address

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 Ventria BioSciences, 4110 North Freeway, Sacramento, CA 95834, for development of a transgenic plant system for the high level expression of outer-surface protein A (OspA) derived from Borrelia burgdorferi, which will be used to deliver an oral vaccine to small animal reservoirs of the Lyme disease bacterium. Lyme disease has become the most common vector-borne illness in the United States, since its discovery in the mid 1970’s. Lyme disease remains a major public health threat due to the increasing range of this disease. It is caused by the spirochete, Borrelia burgdorferi, which naturally lives in mice, squirrels and other small animals. The blacklegged tick, also known as the deer tick (Ixodes scapularis), is the principal vector of Lyme disease spirochetes. These ticks feed on the blood of small animals as part of their normal life cycle, taking up B. burgdorferi into their bodies, where the bacterium can live within the midgut of the tick. While in the midgut of the tick, it was discovered that the B. burgdorferi spirochete produced outer-surface protein A (OspA), which is proven to be antigenic and induce a protective immune response against tick-transmitted B. burgdorferi when animals are immunized. B. burgdorferi can be transmitted to other animals, including deer, and also humans by the bite and subsequent bloodmeal of an infected tick. Although deer are not susceptible to this bacterium, humans typically are, and the result is the condition known as Lyme disease. Symptoms of Lyme disease include fever, headache, fatigue, and often also a rash called erythema migrans. If detected and treated early enough, the disease is fully curable. If left untreated, the disease can spread to the joints, heart and nervous system. It is estimated that there are thousands of people with Lyme disease in the United States, with the numbers steadily increasing each year, since reporting first began in the early 80’s. In 2004, the number of cases reported to the CDC exceeded 20,000. It is also thought that the number of cases in the US is under-reported. In the 1990’s, a vaccine to prevent Lyme disease in humans was made available. The vaccine is based on OspA, which makes up approximately one-third of total spirochete protein. When used in a vaccine, OspA was shown to provide a protective immune response for the recipient of the vaccine to protect against tick-transmitted B. burgdorferi infection. The vaccine was pulled from the market in 2002 by the manufacturer presumably after poor sales and controversial adverse events reported by recipients of the vaccine. Currently, the only options for preventing Lyme disease transmission to humans are tick control methods and personal protective measures, such as repellent use and visual inspection for tick attachment. Our program is exploring the use of OspA again, but this time for use as an oral vaccine to protect small animals, such as mice and squirrels, against infection with the spirochete instead of for human use. The goal is to accomplish widespread immunization of wild animal reservoirs of this disease via natural forage material, such as rice grain, to prevent transmission to reduce the incidence of infection of small animal reservoirs and ticks, and therefore greatly impact transmission of B. burgdorferi to humans through the bite and bloodmeal of black-legged ticks. If done correctly, this should effectively reduce the spread of Lyme disease within endemic communities. The vendor will furnish all labor, materials and equipment necessary to develop a highly effective, but relatively inexpensive, large-scale rice grain delivery system for an oral vaccine designed for small animals, such as mice, and based on the outer-surface protein A (OspA). This OspA oral vaccine delivery system will be used to inoculate wild mice, and other small animal vectors of Lyme disease, against the Borrelia burgdorferi spirochete. The vendor will be responsible for producing and analyzing this delivery system for successful transformation of the OspA protein into the rice grain. Individual vaccination of animals is not acceptable or practical to attain community-wide prevention and control. Summary of specific tasks: 1) Synthesize the OspA gene and verify by sequence analysis; 2) Construct a plasmid that will incorporate the synthesized OspA gene and verify by sequence analysis; 3) Transform this plasmid construct into a rice grain delivery system as specified in the above scope of work; 4) Verify successful transformation by PCR analysis; verify lipidation of the OspA protein; 5) Perform expression analysis to determine the recombinant OspA level in the rice grain by ELISA using anti-OspA antibody available from CDC; 6) Deliver at least (2) new OspA constructs in rice that would be available and in sufficient quantity for in vivo testing, i.e. for (10) in vivo trials utilizing 50 mice per trial, and at least 200 g/mouse total OspA protein; 6) Report. The vendor will be performing the following tasks: 1) Gene synthesis and plasmid construction for rice transformation. The vendor will produce at least 2) transgene constructs – recombinant rice endosperm expressing Borrelia burgdorferi outer-surface protein A (OspA) – using standard molecular cloning techniques. At least (1) construct shall be shown to be lapidated OspA. The vendor shall supply a report on OspA gene synthesis and the plasmid construct. (2) Transformation of plasmids and transgene analysis of transgenic rice plants. The vendor will transform rice by microprojectile bombardment of the transgene construct produced in Task 1. The transformed rice material will be incubated in select media to regenerate rice plants and grow them to maturity. Transgenic rice plants will be screened by PCR analysis to select for only those that are positive for rOspA. 3) Harvest transgenic rice seed for two potential constructs and analyze OspA expression levels. The vendor will harvest the seeds from the OspA-positive rice plants for long-term storage seed stock, analyzing expression of OspA, and for sustaining the next generation of transgenic rice plants. OspA expression will be measured by protein analysis, and quantified via ELISA using anti-OspA antibody provided by CDC. 4) The vendor should be able to deliver to CDC recombinant OspA in sufficient quantity for in vivo testing, i.e. for (10) in vivo trials utilizing 50 mice per trial, and at least 200 g/mouse total OspA protein. The reports specified under specific tasks and deliverables should also address any problems encountered and suggestions for resolution. The vendor will provide one (1) copy to the Project Officer. In addition, the vendor shall report significant problems that impact the progress or schedule of work, as these problems are encountered, directly to the Project Officer. CDC will provide anti-OspA antibody for the vendor to use in determining expression levels of recombinant OspA in the rice grain delivery system. The Project Officer will provide consultation to the vendor on any aspect of the research as needed. The performance period will be for one year from date of award. The vendor will be providing the following deliverables to the Project Officer by the times established below: Report on the gene synthesis and plasmid constructs within 3 months of purchase order award; Report on delivery system and transgenic analysis within 6 months of purchase order award; and Report on OspA expression in the transgenic rice grain demonstrating lipidation of at least one construct produced within 9-12 months of purchase order award. Vendor will retain rights to publication of novel scientific findings obtained. Inclusion of CDC investigators as authors will follow generally accepted standards for authorship based on contributions to the research. Minimum vendor qualifications are as follows: Knowledge of OspA as a potential expression system centering on small animal models, such as mice and squirrels; Demonstrated ability to produce an effective, targeted direct delivery system of measurable quantities of recombinant protein to small animals, primarily wild mice, via a food source, such as rice grain, that they will readily consume; Ability to analyze a delivery system to show successful transgenesis of high levels of recombinant protein; Develop an oral vaccine delivery method that is cost effective, scaleable, and have an adequate shelf-life to ensure proper dose delivery over time after storage and in the field; Vendor must follow federal regulations when using a recombinant protein for oral vaccine use on animals, ensuring that it is deemed environmentally safe and consumer-friendly. 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.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=748abe0c29f0882404beb152cc7e50a3&tab=core&_cview=1)
 

Place of Performance

Address: 4110 N. Freeway, Sacramento, California, 95834, United States

Zip Code: 95834
 

Record

SN01625929-W 20080731/080729225510-748abe0c29f0882404beb152cc7e50a3 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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