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）：每年在美国，人口中有5-20％表现出流感病毒感染的症状。这些人中有11万多人住院，并发症大约36,000人死亡。虽然通常可以通过免疫来避免感染的传播，但疫苗可能缺乏供应，物流可能会限制分布，合规性和缺乏关注限制免疫种群，并且疫苗在非常古老的且非常年轻的情况下不那么有效。今年，指定的H5N1的一种高性毒气的禽流感菌株在整个亚洲和欧洲都迅速传播。关于H5N1的人类感染的报道增加了这种菌株或通常感染人类的​​病毒的重组，可能会扩大其宿主范围以感染人类并导致全球大流行。中度的大流行可能会杀死全球超过3000万人。识别大流行后六个月内可以使用疫苗。但是，流感疫苗的产量有限 - 由于培养病毒的困难，全球只能生产3亿剂剂量，并且能力将需要数年的时间来扩展。此外，如果发生任何广泛的疾病，对人口的迅速分配，医疗保健人员不足以管理疫苗，缺乏针对恐惧症引起的依从性以及其他问题可能会导致人口免疫不良。落基山生物系统公司（Rocky Mountain Biosystems，Inc.自我管理的疫苗接种机电（保存）装置轻轻地减少角质层，在几分钟内施用有效且一致的疫苗，并避免产生构成生物危害废物的“尖锐”。该设备旨在提高药物和疫苗的功效，同时减少剂量并扩展疫苗供应。该设备很小，便宜，可以自给自足，并且可以在大流行时被储存以快速部署。预计该设备将通过适应更有效的疫苗给药的经效率，2）通过无针的自我给药来大大提高合规性，而3）能够快速部署到民众。此外，预计Save的经皮递送将增强细胞免疫与肌肉内接种（IM）接种，从而有可能改善非常年轻的和老年的免疫力。保存技术还可以将透皮药物输送的好处扩展到新药，例如越来越多的大分子药物，脆弱的蛋白质或肽键生物药物。在此提案中，研究人员建议在猪模型中建立斑块的临床前原型，并在体外和体内进行测试，并在人类中测试阻抗。