Stability evaluation of H3N2 influenza split vaccine in drying process for solidification
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Currently, most vaccines have been manufactured in liquid forms that are needed a cold-chain system. However, this system does not guarantee the stability of vaccines always and requires a high cost. Although solidification of vaccine can be alternative, vaccine stability is a problem. Recently, influenza vaccine delivery using microneedle formulation has been studied extensively. Moreover, the stability of the vaccine can be improved since the vaccine is solid form in the microneedle. Therefore, the aim of this study is to screen the suitable stabilizer in the drying process and to compare evaluation methods for H3N2 split vaccine stability.
Dried vaccine samples were evaluated by enzyme-linked immunosorbent assay (ELISA), sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and circular dichroism (CD).
Fructose provided stability to the vaccine during the drying process by ELISA (91.1 ± 8.9%) and SDS-PAGE (about 65%). Trehalose was rated as providing stability to the vaccine when evaluated with ELISA and SDS-PAGE but was not when evaluated with CD.
The stability of the vaccine should be finally determined by comprehensively evaluating the structure and antigenicity of various proteins.
KeywordsH3N2 influenza vaccine Drying process Stability Enzyme-linked immunosorbent assay Sodium dodecyl sulfate polyacrylamide gel electrophoresis Circular dichroism
This work was supported by Industrial Strategic Technology Development Program (10067809, development of vaccine formulation and patient-convenient vaccine microneedle) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea) to Cheong-Weon Cho.
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Conflict of interest
The authors declare that they have no conflict of interest.
Statement of human and animal rights
This article does not contain any studies with human and animal subjects performed by any of the authors.
- Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS (2009) Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep 58:1–54Google Scholar
- Hampson AW (2008) Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singap 37:510Google Scholar
- Plotkin S, Orenstein W, Offit P, Edwards KM (2017) Plotkin’s Vaccines. Elsevier, AmsterdamGoogle Scholar
- Stephenson I, Nicholson KG, Glück R, Mischler R, Newman RW, Palache AM, Verlander NQ, Warburton F, Wood JM, Zambon MC (2003) Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 362:1959–1966CrossRefGoogle Scholar
- Sullivan JS, Selleck PW, Downton T, Boehm I, Axell AM, Ayob Y, Kapitza NM, Dyer W, Fitzgerald A, Walsh B (2009) Heterosubtypic anti-avian H5N1 influenza antibodies in intravenous immunoglobulins from globally separate populations protect against H5N1 infection in cell culture. J Mol Genet Med 3:217Google Scholar
- WHO (2015) Weekly epidemiological record Relevé épidémiologique hebdomadaire 90: 33–44Google Scholar
- WHO (2017a) Influenza. http://www.who.int/biologicals/vaccines/influenza/en/. Accessed 7 Dec 2018
- WHO (2017b) The immunological basis for immunization series. http://www.who.int/immunization/documents/immunological_basis_series/en/. Accessed 7 Dec 2018
- WHO (2018) Influenza (Seasonal) fact-sheets. http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal). Accessed 7 Dec 2018