Self-Administered Vaccination Electromechanical Device for Influenza

流感自行疫苗接种机电装置

• 批准号: 7272238
• 负责人: Kevin Marchitto
• 金额: $ 29.94万
• 依托单位: ROCKY MOUNTAIN BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7272238
• 关键词: Ablation; Address; Adjuvant; Adoption; Adverse event; Anesthesia procedures; Animals; Antibodies; Antibody Formation; Antigens; Asia; Avian Influenza; Back; Biological Assay; Caliber; Cellular Immunity; Clinical; Clinical Trials; Colorado; Consultations; Cutaneous; Data; Dendritic Cells; Development; Device Designs; Device or Instrument Development; Devices; Dimensions; Dose; Drops; Drug Delivery Systems; Effectiveness; Engineering; Epidermis; Europe; Evaluation; Event; Family suidae; Frequencies; Goals; Harvest; Health Personnel; Healthcare; Hemagglutinin; Human; IACUC; Immunity; Immunization; In Vitro; Infection; Influenza; Influenza A Virus, H5N1 Subtype; Influenza Hemagglutinin; Injection of therapeutic agent; Interview; Intramuscular; Intramuscular Injections; Investigation; Laboratories; Liquid substance; Logistics; Marketing; Measures; Medical Device; Methods; Modeling; Monitor; National Institute of Allergy and Infectious Disease; Nature; Needles; Needlestick Injuries; Numbers; Object Attachment; Patch Tests; Peptides; Permeability; Personal Satisfaction; Persons; Pertussis; Pertussis Toxin; Pharmaceutical Preparations; Phase; Phobic anxiety disorder; Population; Positioning Attribute; Powder dose form; Principal Investigator; Product Approvals; Production; Proteins; Randomized; Range; Reaction; Recombinants; Reporting; Research; Research Design; Research Personnel; Risk; Route; Safety; Sampling; Science; Self Administration; Self-Administered; Senior Scientist; Series; Serum; Skin; Solutions; Standards of Weights and Measures; Stratum corneum; Structure; Surface; Surgical Oncology; Sus scrofa; Symptoms; System; Technology; Testing; Thick; Tissues; Transdermal substance administration; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Vaccination; Vaccine Production; Vaccines; Veterinary Medicine; Virulent; Virus; Whooping cough due to unspecified organism; Widespread Disease; Work; World Health Organization; anti-influenza; antigen processing; base; college; commercialization; cost; day; design; design and construction; dosage; drug efficacy; electric impedance; ergonomics; experience; flu; follow-up; human study; improved; in vivo; influenza virus vaccine; influenzavirus; innovation; killings; macromolecule; pandemic disease; pre-clinical; preference; professor; programs; prototype; research clinical testing; response; size; success; therapeutic vaccine; transmission process; vaccine delivery; vaccine efficacy; volunteer; wasting

DESCRIPTION (provided by applicant): Each year in the United States, 5-20% of the population display symptoms of infection with the influenza virus. More than 110,000 of these persons are hospitalized and about 36,000 die from complications. While the spread of infection is generally avoidable through immunization, vaccine may be in short supply, logistics may limit distribution, compliance and lack of concern limit the immunized population and the vaccines are not as efficacious in the very old and very young. This year, a highly virulent avian influenza strain, designated H5N1, has spread rapidly throughout Asia and into Europe. Reports of human infections with H5N1 have increased the concern that this strain, or a recombinant with a virus that commonly infects humans, may expand its host range to infect humans and result in a global pandemic. A moderate pandemic could kill more than 30 million people around the world. A vaccine could be available within six months of recognition of a pandemic. However, influenza vaccine production is limited - only 300 million doses can be manufactured worldwide due to the difficulty in cultivating virus and capacity will take years to expand. Further, in the event of any widespread disease, rapid distribution to the population, insufficient healthcare personnel to administer the vaccine, lack of compliance due to needlestick phobia, and other issues may result in a poorly immunized population. The research proposed by Rocky Mountain Biosystems, Inc. in this application will demonstrate an innovative solution to achieve an immunized, protected population, addressing issues of limited supply, lack of access and compliance. The Self Administered Vaccination Electromechanical (SAVE) device gently and quickly reduces the stratum corneum, administers efficacious and consistent amounts of vaccine in minutes, and avoids creation of "sharps" that constitute biohazardous waste. The device is designed to increase the efficacy of drugs and vaccines, while reducing dosage and extending vaccine supplies. The device is small, inexpensive, self-administrable and can be stockpiled for rapid deployment in the case of a pandemic. The device is expected to 1) extend the vaccine supply as much as 20-fold by adaptation to the more efficient transcutaneous route of vaccine administration, 2) greatly improve compliance through self-administration without needles, and 3) be capable of rapid deployment to the populace. Furthermore, SAVE's transcutaneous delivery is expected to enhance cellular immunity versus intramuscular (IM) inoculation, potentially improving immunity in the very young and old. The SAVE technology may also extend the benefits of transdermal drug delivery to new drugs, such as the growing number of macromolecule drugs and fragile protein or peptide bond biopharmaceuticals. In this proposal, the investigators propose to build pre-clinical prototypes of the patch and test it in vitro and in vivo in a swine model, as well as testing impedance in humans.

描述（由申请人提供）：在美国，每年有 5-20% 的人口出现感染流感病毒的症状。其中超过 110,000 人住院治疗，约 36,000 人死于并发症。虽然通过免疫接种通常可以避免感染的传播，但疫苗可能供应短缺，物流可能限制分发，合规性和缺乏关注限制了免疫人群，而且疫苗对老年人和幼儿并不那么有效。今年，一种被命名为H5N1的高毒力禽流感病毒株在亚洲和欧洲迅速传播。人类感染 H5N1 的报告增加了人们的担忧，即这种病毒株或通常感染人类的​​病毒的重组体可能会扩大其宿主范围以感染人类并导致全球大流行。一场温和的大流行可能会导致全球超过 3000 万人死亡。在确认大流行后六个月内即可获得疫苗。然而，流感疫苗的产量有限——由于病毒培养困难，全球只能生产3亿剂，而且产能需要数年时间才能扩大。此外，如果发生任何广泛传播的疾病，快速向人群传播、没有足够的医护人员来管理疫苗、由于针刺恐惧症而缺乏依从性以及其他问题可能会导致人群免疫不良。落基山生物系统公司在此申请中提出的研究将展示一种创新的解决方案，以实现免疫、受保护的人群，解决供应有限、缺乏获取和合规性的问题。自我管理疫苗机电 (SAVE) 装置可轻柔、快速地减少角质层，在几分钟内注射有效且一致的疫苗量，并避免产生构成生物危害废物的“尖锐物”。该设备旨在提高药物和疫苗的功效，同时减少剂量并扩大疫苗供应。该设备体积小、价格便宜、可自我管理，并且可以储存起来，以便在大流行的情况下快速部署。该设备预计将 1) 通过适应更有效的经皮疫苗接种途径，将疫苗供应量扩大 20 倍，2) 通过无需针头的自我注射大大提高依从性，3) 能够快速部署到民众。此外，与肌肉注射（IM）接种相比，SAVE 的经皮给药有望增强细胞免疫，有可能提高幼儿和老年人的免疫力。 SAVE技术还可能将透皮给药的优势扩展到新药，例如越来越多的大分子药物和脆弱的蛋白质或肽键生物制药。在该提案中，研究人员建议构建该贴片的临床前原型，并在猪模型中进行体外和体内测试，以及测试人体阻抗。