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Using Off-The-Shelf Technologies to Mass Manufacture Oral Vaccine Baits for Wildlife Lucila M

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Using Off-The-Shelf Technologies to Mass Manufacture Oral Vaccine Baits for Wildlife Lucila M University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln USDA National Wildlife Research Center - Staff U.S. Department of Agriculture: Animal and Plant Publications Health Inspection Service 2018 Using Off-the-Shelf Technologies to Mass Manufacture Oral Vaccine Baits for Wildlife Lucila M. Corro Colorado Division of Parks and Wildlife Daniel W. Tripp Colorado Division of Parks and Wildlife Scott A. Stelting CORE Formulations LLC Michael W. Miller Colorado Division of Parks and Wildlife, [email protected] Follow this and additional works at: https://digitalcommons.unl.edu/icwdm_usdanwrc Part of the Life Sciences Commons Corro, Lucila M.; Tripp, Daniel W.; Stelting, Scott A.; and Miller, Michael W., "Using Off-the-Shelf Technologies to Mass Manufacture Oral Vaccine Baits for Wildlife" (2018). USDA National Wildlife Research Center - Staff Publications. 2031. https://digitalcommons.unl.edu/icwdm_usdanwrc/2031 This Article is brought to you for free and open access by the U.S. Department of Agriculture: Animal and Plant Health Inspection Service at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in USDA National Wildlife Research Center - Staff ubP lications by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. U.S. Department of Agriculture U.S. Government Publication Animal and Plant Health Inspection Service Wildlife Services DOI: 10.7589/2017-01-013 Journal of Wildlife Diseases, 53(3), 2017, pp. 681–685 Ó Wildlife Disease Association 2017 Using Off-the-Shelf Technologies to Mass Manufacture Oral Vaccine Baits for Wildlife Lucila M. Corro,1 Daniel W. Tripp,1 Scott A. Stelting,2,3 and Michael W. Miller1,4 1Colorado Division of Parks and Wildlife, Wildlife Health Program, 4330 Laporte Avenue, Fort Collins, Colorado 80521-2153, USA; 2US Department of Agriculture, Animal and Plant Health Inspection Service (APHIS), Wildlife Services, National Wildlife Research Center, 4101 Laporte Avenue, Fort Collins, Colorado 80521, USA; 3Present address: CORE Formulations LLC, 804 Nelson Park Lane, Longmont, Colorado 80503, USA; 4Corresponding author (e-mail: [email protected]) ABSTRACT: Technology and infrastructure costs trials have been undertaken, but landscape- can limit access to oral vaccination tools for scale application via mechanized delivery will wildlife disease control. We describe vaccine bait be needed for biologically meaningful plague mass manufacturing employing off-the-shelf tech- nologies. Our approach has helped advance control (Johnson et al. 2014; Tripp et al. scaling-up of plague vaccination campaigns, but 2015; USFWS 2016). Here we describe key components of this production system could be elements of a vaccine carrier bait mass- translated into other wildlife vaccination applica- manufacturing approach employing off-the- tions. shelf technologies. Our approach had imme- diate application in aiding the development Oral vaccination offers a prospective tool of mechanical bait distribution for plague for controlling a variety of wildlife diseases vaccination campaigns in western North (Cross et al. 2007; Artois et al. 2011). The America, but this production system could most notable successes with wildlife vaccina- be adapted to other wildlife vaccination tion have been the European and North applications. American campaigns against rabies (Cross et Baits carrying plague vaccine (the geneti- al. 2007; Sterner et al. 2009; Artois et al. cally-modified raccoonpox virus strain RCN- 2011). Mass oral vaccination of wildlife relies F1/V307; Rocke et al. 2014) consists mainly of on availability of effective immunogens and distilled water, an attractant (peanut butter), suitable bait delivery technology (Cross et al. and a patented, gelatin-based biopolymer 2007; Artois et al. 2011). Unfortunately, the matrix (Incortrixt, FoodSource Lures Corpo- necessary investments in technology and ration, Birmingham, Alabama, USA) used infrastructure (Sterner et al. 2009) have previously as a carrier for a recombinant largely limited access to oral vaccination for vaccinia-Lyme disease vaccine (Table 1; large-scale uses other than rabies control. Bhattacharya et al. 2011; FoodSource 2013). Versatile and affordable approaches for wild- Three critical features of the biopolymer life vaccination could be beneficial. matrix are: 1) live vaccines can be incorporat- Plague—a disease with human and wildlife ed into the mix at a temperature low enough health implications—occurs in wild rodent to assure viability; 2) the vaccine bait mixture reservoirs worldwide (World Health Organi- remains malleable at this lower temperature; zation 2016). Since its introduction in the and 3) the vaccine remains viable through early 1900s, plague has disrupted grassland drying (Bhattacharya et al. 2011; FoodSource and shrub-steppe ecosystems throughout 2013). Vaccine-laden baits made with this much of western North America, contribut- matrix can be shaped and sized according to ing to the near-extirpation of several native target species because vaccine is distributed species, including prairie dogs (Cynomys throughout the bait material. spp.; Abbott et al. 2012). Consequently, work Bench-top approaches for making vaccine has been underway since the early 2000s to baits suffice for laboratory studies and small- develop oral vaccination as a plague manage- scale field trials, but cannot support land- ment tool (Abbott et al. 2012; Johnson et al. scape-level endeavors. As a step toward 2014; Rocke et al. 2014). Small-scale field meeting larger-scale demands, we modified 681 682 JOURNAL OF WILDLIFE DISEASES, VOL. 53, NO. 3, JULY 2017 TABLE 1. Ingredient amounts in a formulation for machines produce round, uniform fishing mass-produced baits carrying plague vaccine (RCN- baits or ‘‘boilies’’ of user-specified diameter. F1/V307). We used 8-kg batches as a standard to accommodate processing through a semiautomated We elected to produce 14-mm-diameter baits bait-making machine. See the Supplementary Material (mass about 2.1 g wet, each). A video of for additional details on vaccine bait making proce- vaccine bait manufacturing is given as part of dures using this system. the Supplementary Material. We produced vaccine baits under Biosafe- a Ingredient Weight (g) Percentage Change ty Level II conditions (detailed in the Supplementary Material). Each 8 kg batch Distilled water 4,322 53.8 1.153 b yielded about 3,800 baits, a .10-fold im- Incortrix powder 2,319 28.8 0.823 Peanut butterc 1,159 14.4 0.923 provement over bench-top production. Initial Blue dye powder 40 0.5 steps approximated those of Bhattacharya et Vaccine fluid 200 2.5 al. (2011): we mixed all ingredients at 65À70 Total 8,040 C except the plague vaccine (Yersinia Pestis a Multiplier for proportional difference from small-batch formu- Vaccine, Live Raccoon Poxvirus Vector, lation provided by the US Geological Survey. Other manipula- Code 11Y2.R0; Colorado Serum Company, tions explored as overviewed in the Supplementary Material Denver, Colorado, USA), then added the (Table S1). b vaccine after cooling the bait slurry to 35À40 FoodSource Lures Corporation, Birmingham, Alabama, USA. c An organic, pure peanut butter product that does not contain C. We then poured the complete vaccine-bait palm kernel oil or other additives is recommended. See mixture—still as a liquid slurry—into an Supplementary Material Table S1. aluminum extrusion tube. We sealed the extrusion tubes with plastic wrap to reduce bait formulation and manufacturing practices moisture loss and allowed the formulation to ~ ~ in order to facilitate adaptive plague vaccina- hydrate and solidify overnight ( 12 h) at 21 tion campaigns in Colorado, US and else- C. This essential time period allowed the where. We used a series of exploratory matrix to fully hydrate, thereby ensuring experiments (Supplementary Material Table cohesiveness during rolling. After hydration, S1) to increase malleability of the vaccine-bait the extrusion tube was connected to the slurry at room temperature. We ultimately manufacturing machine. Finished baits were effected the desired change by increasing dried for 48À96 h (relative humidity 40%), relative water content and allowing ample then weighed, bagged, and stored frozen time for matrix saturation (Table 1 and until used. Finished baits weighed 0.9À1g Supplementary Table S1). We also substituted dry and remained generally uniform, but FD&C Blue #1 food dye for the rhodamine B became somewhat less spherical during biomarker (Fernandez and Rocke 2011) to drying (Fig. 1B). decrease bait size, maintain palatability, and Extrusion under pressure 210,000–344,000 enhance attractiveness to prairie dogs (Cain pascal (30À50 psi) did not appear to affect and Carlson 1968). This change sacrificed vaccine viability. Dried baits collected from ability to biomark individuals consuming baits. the beginning and end of runs yielded Instead, we use observation of blue-stained comparable live RCN-F1/V307 virus counts feces to confirm vaccine uptake by target (Supplementary Fig. S1). Virus counts from species. dry baits were lower than target doses These modifications allowed us to exploit an (Supplementary Fig. S1) but approximated off-the-shelf mass production system for bait the ~10-fold discrepancies between target manufacture (Fig. 1 and Supplementary and measured RCN counts that we and others Material). We adapted a ‘‘carp bait’’ produc- have encountered in bench-top-made vaccine tion machine (BoilieRoller Machine, Midland baits (e.g., Mencher
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