Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch

Hirobe, Sachiko; Azukizawa, Hiroaki; Hanafusa, Takaaki; Matsuo, Keitaro; Quan, Ying‐Shu; Kamiyama, Fumio; Katayama, Ichiro; Okada, Naoki; Nakagawa, Shinsaku

doi:10.1016/j.biomaterials.2015.04.007

Cited by 197 publications

(152 citation statements)

References 17 publications

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“…A dissolving MN using a hydrophilic biopolymer has been developed because it need no disposal, could be selfadministered, would have good stability and shelf life [18][19][20][21][22]. Previous studies have demonstrated that TD vaccination in combination with SV vaccines prepared from seasonal influenza viruses using a dissolving biopolymer needle induced higher antibody responses than SC vaccination in humans [18].…”

Section: Introductionmentioning

confidence: 98%

Potency of whole virus particle and split virion vaccines using dissolving microneedle against challenges of H1N1 and H5N1 influenza viruses in mice

Nakatsukasa

Kuruma

Okamatsu

et al. 2017

Vaccine

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Transdermal vaccination using a microneedle (MN) confers enhanced immunity compared with subcutaneous (SC) vaccination. Here we developed a novel dissolving MN patch for the influenza vaccine. The potencies of split virion and whole virus particle (WVP) vaccines prepared from A/Puerto Rico/8/1934 (H1N1) and A/duck/Hokkaido/Vac-3/2007 (H5N1), respectively, were evaluated. MN vaccination induced higher neutralizing antibody responses than SC vaccination in mice. Moreover, MN vaccination with a lower dose of antigens conferred protective immunity against lethal challenges of influenza viruses than SC vaccination in mice. These results suggest that the WVP vaccines administered using MN are an effective combination for influenza vaccine to be further validated in humans.

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Section: Introductionmentioning

confidence: 98%

Potency of whole virus particle and split virion vaccines using dissolving microneedle against challenges of H1N1 and H5N1 influenza viruses in mice

Nakatsukasa

Kuruma

Okamatsu

et al. 2017

Vaccine

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“…To our knowledge, such long-term stability of influenza vaccine in microneedle patches at such elevated temperatures has not been demonstrated. Recently, a dextran-based influenza vaccine-loaded DMN system [25] or hyaluronic acid-based microneedle patch system [48] demonstrated lower stability compared to our system when samples were stored at ambient (25ºC) or accelerated (40ºC) temperatures and tested using SRID or in vivo. However, a monovalent influenza vaccine demonstrated promising stability at 25ºC for 3 months [32] and using in-house ELISA-based assays, other formulations have been suggested for stabilizing influenza vaccines in microneedle structures [49] Other efforts that incorporated TIV onto transcutaneous patches were also less successful at elevated temperatures; however the relative stability of the H1N1 compared to H3N2 antigens was also observed in this study [50].…”

Section: Accepted M Manuscriptmentioning

confidence: 99%

Induction of broad immunity by thermostabilised vaccines incorporated in dissolvable microneedles using novel fabrication methods

Vrdoljak

Allen

Ferrara

et al. 2016

Journal of Controlled Release

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT

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“…20,[29][30][31] The stability of inactivated viruses and protein antigens has been established in certain dissolvable microneedle formulations [32][33][34] however, little investigation has been done to determine whether incorporation into dissolvable microneedles has any influence on the stability of DNA or to directly compare the suitability of different polymer matrices to deliver nucleic acid cargo. This is perhaps surprising given that some polymers have been known to form hydrogen bonds with DNA and have been reported to be capable of enhancing gene delivery in their own right.…”

Section: Introductionmentioning

confidence: 99%

Dissolving microneedles for DNA vaccination: Improving functionality via polymer characterization and RALA complexation

Cole

McCaffrey

Ali

et al. 2016

Human Vaccines & Immunotherapeutics

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DNA vaccination holds the potential to treat or prevent nearly any immunogenic disease, including cancer. To date, these vaccines have demonstrated limited immunogenicity in vivo due to the absence of a suitable delivery system which can protect DNA from degradation and improve transfection efficiencies in vivo. Recently, microneedles have been described as a novel physical delivery technology to enhance DNA vaccine immunogenicity. Of these devices, dissolvable microneedles promise a safe, pain-free delivery system which may simultaneously improve DNA stability within a solid matrix and increase DNA delivery compared to solid arrays. However, to date little work has directly compared the suitability of different dissolvable matrices for formulation of DNA-loaded microneedles. Therefore, the current study examined the ability of 4 polymers to formulate mechanically robust, functional DNA loaded dissolvable microneedles. Additionally, complexation of DNA to a cationic delivery peptide, RALA, prior to incorporation into the dissolvable matrix was explored as a means to improve transfection efficacies following release from the polymer matrix. Our data demonstrates that DNA is degraded following incorporation into PVP, but not PVA matrices. The complexation of DNA to RALA prior to incorporation into polymers resulted in higher recovery from dissolvable matrices, and increased transfection efficiencies in vitro. Additionally, RALA/DNA nanoparticles released from dissolvable PVA matrices demonstrated up to 10-fold higher transfection efficiencies than the corresponding complexes released from PVP matrices, indicating that PVA is a superior polymer for this microneedle application.

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Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch

Cited by 197 publications

References 17 publications

Potency of whole virus particle and split virion vaccines using dissolving microneedle against challenges of H1N1 and H5N1 influenza viruses in mice

Potency of whole virus particle and split virion vaccines using dissolving microneedle against challenges of H1N1 and H5N1 influenza viruses in mice

Induction of broad immunity by thermostabilised vaccines incorporated in dissolvable microneedles using novel fabrication methods

Dissolving microneedles for DNA vaccination: Improving functionality via polymer characterization and RALA complexation

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