Self-Administered Vaccination Electromechanical Device for Influenza

流感自行疫苗接种机电装置

• 批准号: 7390638
• 负责人: Kevin Marchitto
• 金额: $ 29.99万
• 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 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7390638
• 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%的人口表现出流感病毒感染的症状。其中110 000多人住院，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，但疫苗可能短缺，物流可能限制分配，遵守和缺乏关注限制了免疫人群，疫苗对非常年老和非常年幼的人不那么有效。今年，一种称为H5N1的高致病性禽流感病毒株迅速蔓延到整个亚洲并进入欧洲。人类感染H5N1病毒的报告增加了人们的担忧，即这种毒株或与通常感染人类的病毒的重组体可能扩大其宿主范围以感染人类并导致全球大流行。一场中度流行病可能导致全球3000多万人死亡。在确认大流行后的六个月内，可以获得疫苗。然而，流感疫苗的生产是有限的-由于培养病毒的困难，全球只能生产3亿剂，而且产能需要数年才能扩大。此外，在任何广泛传播的疾病的情况下，快速分发给人群，没有足够的医疗保健人员来管理疫苗，由于针刺恐惧症而缺乏依从性，以及其他问题可能导致免疫接种不足的人群。由Rocky Mountain Biosystems，Inc.在这个应用程序将展示一个创新的解决方案，以实现免疫，保护人口，解决供应有限，缺乏访问和遵守的问题。自助接种机电（SAVE）装置温和快速地减少角质层，在几分钟内接种有效和一致量的疫苗，并避免产生构成生物危害性废物的"尖锐物"。该设备旨在提高药物和疫苗的功效，同时减少剂量并延长疫苗供应。该装置体积小、价格便宜、可自我管理，并可储存起来，以便在大流行病发生时迅速部署。该装置预计将1）通过适应更有效的经皮疫苗接种途径，将疫苗供应延长20倍，2）通过无针自我接种大大提高依从性，3）能够快速部署到人群中。此外，预计SAVE的经皮给药将增强细胞免疫力，而不是肌内（IM）接种，可能会提高年幼和年老者的免疫力。SAVE技术还可以将经皮给药的益处扩展到新药，例如越来越多的大分子药物和脆性蛋白质或肽键生物药物。在这项提案中，研究人员建议建立贴片的临床前原型，并在猪模型中进行体外和体内测试，以及在人体中测试阻抗。