Formulation of Ambient Temperature and Humidity Stable Rabies Vaccines

环境温度和湿度稳定的狂犬病疫苗的配制

• 批准号: 8088192
• 负责人: Victor Bronshtein
• 金额: $ 63.4万
• 依托单位: UNIVERSAL STABILIZATION TECHNOLOGIES
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8088192
• 关键词: Acids; Alginates; Americas; Animals; Bile Acids; Biological; Biological Preservation; Bite; Canis familiaris; Cell Nucleus; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Chiroptera; Coyotes; Development; Disease; Disease Vectors; Domestic Animals; Drug Formulations; Eating; Elements; Encapsulated; Environment; Felis catus; Ferrets; Food; Foxes; Gastric Juice; Gastrointestinal tract structure; Gel; Glass; Goals; Health; Heating; Hour; Human; Humidity; Immune response; Intestinal Mucosa; Intestines; Legal patent; Living Costs; Measures; Mephitidae; Microspheres; Mucous Membrane; Oils; Oral cavity; Pharyngeal structure; Phase; Preventive; Rabies; Rabies Vaccines; Raccoons; Saliva; Small Intestines; Stomach; Sunlight; Technology; Temperature; Vaccination; Vaccine Design; Vaccines; Vaccinia; Vaccinium; Wild Animals; base; feral; novel; oral vaccine; vaccine efficacy; vaporization

DESCRIPTION (provided by applicant): Rabies is a deadly disease, estimated to cause 40-70 thousand deaths per year. It is most often spread by a bite and saliva from an infected wild or feral animal (e.g., bats, raccoons, skunks, foxes, ferrets, cats, or dogs). Oral vaccines in bait have been successful with animals that chew their food, thus allowing the vaccine bait to come into contact with the mouth and throat mucosa to elicit the immune response. However, canid species (dogs, foxes, coyotes) ,the primary vectors of the disease to humans, do not chew their food or the bait; rather it gulped down causing the vaccine to be destroyed in the stomach acid. For our Phase 1 project, we combined two technologies to prepare a novel form of rabies vaccine, designed to be stable at ambient temperatures and in harsh environments, such as during the journey through stomach acid and bile secretion on its way to the small intestine where we propose it can immunize the animal through the intestinal mucosa. The PI's patent pending "Preservation by Vaporization" (PBV) technology which immobilizes sensitive biologicals in the "glass state" so they are stable at ambient temperatures has been utilized with alginate gel encapsulation to protect vaccines from heat and chemical damage. UST utilized PBV to dry-preserve two alginate-encapsulated vaccines VRG (vaccinia-based) and ERA (Rabies based). We exceeded our original target specifications for vaccine stability during 1 hour equilibration at 60¿C, and after 2 weeks at 37¿C. The specific aims of the Phase II project are to: 1) Optimize formulation of dry preserved rabies vaccines encapsulated in alginate gel microspheres. 2) Formulate Rabies Vaccine Animal Bait Nucleus (RVABN) filled with VRG and with ERA vaccines. 3) Evaluate efficacy of the vaccine products in animal studies - specifically foxes and dogs - against a rabies challenge. The long-range goal of this project is to produce an oral vaccine for rabies secreted in bait that is stable in the wild. This vaccine, once eaten by wild animals will not be destroyed in the GI tract and will produce a strong immune response in the intestine. UST will partner with CDC and Merial Ltd. who will provide the vaccine and help to perform animal studies. PUBLIC HEALTH RELEVANCE: The number of deaths that rabies causes each year is estimated to be between 40,000- 70,000. The cost of living with rabies in America is high and growing, exceeding $300 million per year. Although rabies vaccinations have been available for domestic animals for many years, only recently have such preventive measures been developed to control rabies in wildlife. Development of baits that would have stable rabies vaccines embedded in edible hydrogenated oils such that the vaccines are protected from the elements, including sunlight, temperature, humidity and gastric juices, could allow vaccination of wild animals so they do not get rabies, and thus could help eradicate the disease.

描述（由申请人证明）：狂犬病是一种致命的疾病，估计会导致40-7万人死亡。 。 对于我们的第1阶段项目，我们将两种技术组合在一起，以准备狂犬病疫苗SH环境的阳离子，例如在通过胃酸胆汁分泌的过程中，我们提出的是肠道粘膜，而PI的专利持续存在。 “通过汽化保存”将敏感的生物学固定在“因此，在环境温度下的稳定性已经与appulati一起使用，以保护疫苗免受热和化学损害。UST利用PBV来干燥两种藻类疫苗VRG（vaccinia vrg（vaccinia bassed bassed bassed bassed） ）。 c，在37讲2周后C II期项目的具体目的是：1）在藻酸盐凝胶微孔中封装的干燥保留疫苗的配方。动物研究 - 特定于狐狸和狗 - 激发狂犬病挑战。 在野生诱饵表中生产狂犬病稳定的远程疫苗将不会在胃肠道中设计，并且会在与CDC和Merial Ltd的伴侣中产生强大的IMUNE响应。将提供疫苗并有助于进行动物研究。 公共卫生相关性：AM Erica的生活成本很高，并且增长了3亿美元的peries疫苗接种多年，直到最近才制定了这种措施来控制野生动物的狂犬病。这种疫苗受到保护，免受元素，温度中度和胃果汁的保护，可以允许疫苗使疫苗不受狂犬病，因此可以帮助eeracite疾病。