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(申请人提供)：在美国，每年有5%-20%的人口表现出感染流感病毒的症状。这些人中有11万多人住院，约3.6万人死于并发症。虽然感染的传播一般可以通过免疫来避免，但疫苗可能供不应求，物流可能会限制分发，遵从性和缺乏关注度限制了接种的人口，疫苗对非常年长和非常年轻的人不那么有效。今年，一种名为H5N1的高毒力禽流感病毒株在整个亚洲和欧洲迅速传播。有关人类感染H5N1病毒的报道加剧了人们的担忧，即这种毒株或与通常感染人类的病毒重组的毒株可能会扩大宿主范围，感染人类，并导致全球大流行。一场适度的大流行可能会导致全球3000多万人死亡。疫苗可能在确认大流行后六个月内可用。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3亿剂流感疫苗，能力将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、由于针头恐惧症而缺乏遵从性，以及其他问题，可能会导致人群免疫不足。落基山生物系统公司在这项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、受保护的人口，解决供应有限、缺乏机会和合规的问题。自行接种机电(SAVE)装置温和而快速地减少角质层，在几分钟内注射有效和一致的疫苗，并避免产生构成生物危险废物的“尖锐”。该设备旨在提高药物和疫苗的疗效，同时减少剂量和扩大疫苗供应。该设备体积小、价格便宜、可自我管理，可以储存起来，以便在大流行情况下快速部署。预计该设备将1)通过适应更有效的经皮给药途径将疫苗供应扩大20倍，2)通过无需针头的自我给药大大提高依从性，3)能够快速部署到民众中。此外，与肌肉注射(IM)相比，SAVE的经皮给药有望增强细胞免疫，潜在地提高非常年轻和非常年长的人的免疫力。SAVE技术还可能将经皮给药的好处扩展到新药，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，并在猪模型上进行体外和体内测试，以及在人类身上测试阻抗。