Improved immunogenicity of individual influenza vaccine components delivered with a novel dissolving microneedle patch stable at room temperature

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• 作者：Elena V. Vassilieva ; Haripriya Kalluri…
• 关键词：Dissolving microneedle patches ; Metal microneedle arrays ; Skin immunization ; Influenza vaccines ; Mouse model
• 刊名：Drug Delivery and Translational Research
• 出版年：2015
• 出版时间：August 2015
• 年：2015
• 卷：5
• 期：4
• 页码：360-371
• 全文大小：1,131 KB
• 参考文献：1.del Pilar Martin M, Weldon WC, Zarnitsyn VG, Koutsonanos DG, Akbari H, Skountzou I, et al. Local response to microneedle-based influenza immunization in the skin. mBio. 2012;3(2):e00012-2. doi:10.-128/?mBio.-0012-12 .PubMed Central PubMed
  2.Chen X, Fernando GJ, Raphael AP, Yukiko SR, Fairmaid EJ, Primiero CA, et al. Rapid kinetics to peak serum antibodies is achieved following influenza vaccination by dry-coated densely packed microprojections to skin. J Control Release Off J Control Release Soc. 2012;158(1):78-4. doi:10.-016/?j.?jconrel.-011.-0.-26 .View Article
  3.Pulit-Penaloza JA, Esser ES, Vassilieva EV, Lee JW, Taherbhai MT, Pollack BP, et al. A protective role of murine langerin(+) cells in immune responses to cutaneous vaccination with microneedle patches. Sci Rep. 2014;4:6094. doi:10.-038/?srep06094 .PubMed Central PubMed View Article
  4.Quinn HL, Kearney MC, Courtenay AJ, McCrudden MT, Donnelly RF. The role of microneedles for drug and vaccine delivery. Expert Opin Drug Deliv. 2014;11(11):1769-0. doi:10.-517/-7425247.-014.-38635 .PubMed View Article
  5.Skountzou I, Compans RW. Skin immunization with influenza vaccines. Curr Top Microbiol Immunol. 2015;386:343-9. doi:10.-007/-2_-014_-07 .PubMed
  6.Levin Y, Kochba E, Hung I, Kenney R. Intradermal vaccination using the novel microneedle device MicronJet600: past, present and future. Hum Vaccines Immunother. 2015. doi:10.-080/-1645515.-015.-010871 .
  7.Barkam S, Saraf S, Seal S. Fabricated micro-nano devices for in vivo and in vitro biomedical applications. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2013;5(6):544-8. doi:10.-002/?wnan.-236 .PubMed View Article
  8.Jin J, Reese V, Coler R, Carter D, Rolandi M. Chitin microneedles for an easy-to-use tuberculosis skin test. Adv Healthcare Mater. 2014;3(3):349-3. doi:10.-002/?adhm.-01300185 .View Article
  9.Paliwal S, Hwang BH, Tsai KY, Mitragotri S. Diagnostic opportunities based on skin biomarkers. Eur J Pharm Sci Off J Eur Fed Pharm Sci. 2013;50(5):546-6. doi:10.-016/?j.?ejps.-012.-0.-09 .
  10.Koutsonanos DG, Compans RW, Skountzou I. Targeting the skin for microneedle delivery of influenza vaccine. Adv Exp Med Biol. 2013;785:121-2. doi:10.-007/-78-1-4614-6217-0_-3 .PubMed View Article
  11.Qiu Y, Guo L, Zhang S, Xu B, Gao Y, Hu Y et al. DNA-based vaccination against hepatitis B virus using dissolving microneedle arrays adjuvanted by cationic liposomes and CpG ODN. Drug Delivery. 2015:1-. doi:10.-109/-0717544.-014.-92497 .
  12.Carey JB, Vrdoljak A, O’Mahony C, Hill AV, Draper SJ, Moore AC. Microneedle-mediated immunization of an adenovirus-based malaria vaccine enhances antigen-specific antibody immunity and reduces anti-vector responses compared to the intradermal route. Sci Rep. 2014;4:6154. doi:10.-038/?srep06154 .PubMed Central PubMed View Article
  13.van der Maaden K, Trietsch SJ, Kraan H, Varypataki EM, Romeijn S, Zwier R, et al. Novel hollow microneedle technology for depth-controlled microinjection-mediated dermal vaccination: a study with polio vaccine in rats. Pharm Res. 2014;31(7):1846-4. doi:10.-007/?s11095-013-1288-9 .PubMed
  14.Prow TW, Chen X, Prow NA, Fernando GJ, Tan CS, Raphael AP, et al. Nanopatch-targeted skin vaccination against West Nile virus and Chikungunya virus in mice. Small. 2010;6(16):1776-4. doi:10.-002/?smll.-01000331 .PubMed View Article
  15.Suh H, Shin J, Kim YC. Microneedle patches for vaccine delivery. Clin Exp Vaccine Res. 2014;3(1):42-. doi:10.-774/?cevr.-014.-.-.-2 .PubMed Central PubMed View Article
  16.Hirobe S, Azukizawa H, Matsuo K, Zhai Y, Quan YS, Kamiyama F, et al. Development and clinical study of a self-dissolving microneedle patch for transcutaneous immunization device. Pharm Res. 2013;30(10):2664-4. doi:10.-007/?s11095-013-1092-6 .PubMed View Article
  17.Gill HS, Prausnitz MR. Pocketed microneedles for drug delivery to the skin. J Phys Chem Solids. 2008;69(5-):1537-1. doi:10.-016/?j.?jpcs.-007.-0.-59 .PubMed Central PubMed View Article
  18.Haq MI, Smith E, John DN, Kalavala M, Edwards C, Anstey A, et al. Clinical administration of microneedles: skin puncture, pain and sensation. Biomed Microdevices. 2009;11(1):35-7. doi:10.-007/?s10544-008-9208-1 .PubMed View Article
  19.Gupta J, Gill HS, Andrews SN, Prausnitz MR. Kinetics of skin resealing after insertion of microneedles in human subjects. J Control Release Off J Control Release Soc. 2011;154(2):148-5. doi:10.-016/?j.?jconrel.-011.-5.-21 .View Article
  20.Norman JJ, Arya JM, McClain MA, Frew PM, Meltzer MI, Prausnitz MR. Microneedle patches: usability and acceptability for self-vaccination against influenza. Vaccine. 2014. doi:10.-016/?j.?vaccine.-014.-1.-76 .PubMed Central
  21.Zhu Q, Zarnitsyn VG, Ye L, Wen Z, Gao Y, Pan L, et al. Immunization by vaccine-coated microneedle arrays protects against lethal influenza virus challenge. Proc Natl Acad Sci U S A. 2009;106(19):79
• 作者单位：Elena V. Vassilieva (1)
  Haripriya Kalluri (2)
  Devin McAllister (2)
  Misha T. Taherbhai (1)
  E. Stein Esser (1)
  Winston P. Pewin (2)
  Joanna A. Pulit-Penaloza (1) (3)
  Mark R. Prausnitz (2)
  Richard W. Compans (1)
  Ioanna Skountzou (1)
  
  1. Department of Microbiology & Immunology and Emory Vaccine Center, Emory University School of Medicine, 1518 Clifton Road, Atlanta, GA, 30322, USA
  2. School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA, 30332-0100, USA
  3. Influenza Division, Centers for Disease Control, Atlanta, GA, 30322, USA
  
• 刊物主题：Pharmaceutical Sciences/Technology;
• 出版者：Springer US
• ISSN：2190-3948

文摘

Prevention of seasonal influenza epidemics and pandemics relies on widespread vaccination coverage to induce protective immunity. In addition to a good antigenic match with the circulating viruses, the effectiveness of individual strains represented in the trivalent vaccines depends on their immunogenicity. In this study, we evaluated the immunogenicity of H1N1, H3N2, and B seasonal influenza virus vaccine strains delivered individually with a novel dissolving microneedle patch and the stability of this formulation during storage at 25?°C. Our data demonstrate that all strains retained their antigenic activity after incorporation in the dissolving patches as measured by single radial diffusion (SRID) assay and immune responses to vaccination in BALB/c mice. After a single immunization, all three antigens delivered with microneedle patches induced superior neutralizing antibody titers compared to intramuscular immunization. Cutaneous antigen delivery was especially beneficial for the less immunogenic B strain. Mice immunized with dissolving microneedle patches encapsulating influenza A/Brisbane/59/07 (H1N1) vaccine were fully protected against lethal challenge by homologous mouse-adapted influenza virus. All vaccine components retained activity during storage at room temperature for at least 3?months as measured in vitro by SRID assay and in vivo by mouse immunization studies. Our data demonstrate that dissolving microneedle patches are a promising advance for influenza cutaneous vaccination due to improved immune responses using less immunogenic influenza antigens and enhanced stability.