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Pharm Res. 2016 Apr;33(4):868-78. doi: 10.1007/s11095-015-1833-9. Epub 2015 Dec 1.

Enhanced Stability of Inactivated Influenza Vaccine Encapsulated in Dissolving Microneedle Patches.

Author information

1
Wallace H. Coulter Department of Biomedical Engineering, Georgia Technology and Emory University, Georgia Institute of Technology, Atlanta, Georgia, 30332, USA.
2
Department of Microbiology and Immunology and Emory Vaccine Center, Emory University School of Medicine, Atlanta, Georgia, 30329, USA.
3
Wallace H. Coulter Department of Biomedical Engineering, Georgia Technology and Emory University, Georgia Institute of Technology, Atlanta, Georgia, 30332, USA. prausnitz@gatech.edu.
4
School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, Georgia, 30332, USA. prausnitz@gatech.edu.

Abstract

PURPOSE:

This study tested the hypothesis that encapsulation of influenza vaccine in microneedle patches increases vaccine stability during storage at elevated temperature.

METHODS:

Whole inactivated influenza virus vaccine (A/Puerto Rico/8/34) was formulated into dissolving microneedle patches and vaccine stability was evaluated by in vitro and in vivo assays of antigenicity and immunogenicity after storage for up to 3 months at 4, 25, 37 and 45°C.

RESULTS:

While liquid vaccine completely lost potency as determined by hemagglutination (HA) activity within 1-2 weeks outside of refrigeration, vaccine in microneedle patches lost 40-50% HA activity during or shortly after fabrication, but then had no significant additional loss of activity over 3 months of storage, independent of temperature. This level of stability required reduced humidity by packaging with desiccant, but was not affected by presence of oxygen. This finding was consistent with additional stability assays, including antigenicity of the vaccine measured by ELISA, virus particle morphological structure captured by transmission electron microscopy and protective immune responses by immunization of mice in vivo.

CONCLUSIONS:

These data show that inactivated influenza vaccine encapsulated in dissolving microneedle patches has enhanced stability during extended storage at elevated temperatures.

KEYWORDS:

influenza vaccine immunogenicity; microneedle patch; thermostability; vaccine stability

PMID:
26620313
PMCID:
PMC4777640
DOI:
10.1007/s11095-015-1833-9
[Indexed for MEDLINE]
Free PMC Article

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