Improving the reach of vaccines to low-resource regions, with a needle-free vaccine delivery device and long-term thermostabilization

• Published in: Journal of controlled release Vol. 152; no. 3; pp. 349 - 355
• Main Authors: Chen, Xianfeng, Fernando, Germain J.P., Crichton, Michael L., Flaim, Christopher, Yukiko, Sally R., Fairmaid, Emily J., Corbett, Holly J., Primiero, Clare A., Ansaldo, Alexander B., Frazer, Ian H., Brown, Lorena E., Kendall, Mark A.F.
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 30.06.2011; Elsevier
• Subjects: affordability; animal models; Animals; Antibodies - blood; Antibodies - immunology; antigen-presenting cells; Biological and medical sciences; coatings; Dermis - pathology; Dermis - ultrastructure; Developing Countries; Drug Delivery Systems - economics; Drug Delivery Systems - instrumentation; Drug Delivery Systems - methods; Drug Stability; drying; Epidermis - pathology; Epidermis - ultrastructure; General pharmacology; Hemagglutination Inhibition Tests; immune response; influenza; Influenza Vaccines - administration & dosage; Influenza Vaccines - chemistry; Influenza Vaccines - economics; Influenza Vaccines - immunology; intramuscular injection; Medical sciences; Methylcellulose - chemistry; Mice; Mice, Inbred C57BL; Microprojection; Microscopy, Electron, Scanning; Orthomyxoviridae - immunology; Ovalbumin - administration & dosage; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Silicon - chemistry; Skin - immunology; Skin - pathology; Skin - ultrastructure; Sus scrofa; temperature; thermal stability; Thermostability; Vaccination - instrumentation; Vaccination - methods; Vaccine coating; vaccines; Vaccines - administration & dosage; Vaccines - chemistry; Vaccines - economics; Vaccines - immunology; Thermostability; Vaccine coating; Microprojection; Delivery system; Coating material; Pharmaceutical technology; Thermal stabilization; Vaccine; Coating; Long term; Thermal stability
• ISSN: 0168-3659; 1873-4995
• DOI: 10.1016/j.jconrel.2011.02.026

Dry-coated microprojections can deliver vaccine to abundant antigen-presenting cells in the skin and induce efficient immune responses and the dry-coated vaccines are expected to be thermostable at elevated temperatures. In this paper, we show that we have dramatically improved our previously reported gas-jet drying coating method and greatly increased the delivery efficiency of coating from patch to skin to from 6.5% to 32.5%, by both varying the coating parameters and removing the patch edge. Combined with our previous dose sparing report of influenza vaccine delivery in a mouse model, the results show that we now achieve equivalent protective immune responses as intramuscular injection (with the needle and syringe), but with only 1/30th of the actual dose. We also show that influenza vaccine coated microprojection patches are stable for at least 6 months at 23 °C, inducing comparable immunogenicity with freshly coated patches. The dry-coated microprojection patches thus have key and unique attributes in ultimately meeting the medical need in certain low-resource regions with low vaccine affordability and difficulty in maintaining “cold-chain” for vaccine storage and transport. Influenza vaccine coated microprojection patches are stable for at least 6 months at 23 °C, inducing comparable immunogenicity with freshly coated patches. [Display omitted]