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dc.contributor.authorWanandy, Troyen_US
dc.contributor.authorHonda-Okubo, Yoshikazuen_US
dc.contributor.authorDavies, Noel Wen_US
dc.contributor.authorRose, Hayley Een_US
dc.contributor.authorHeddle, Robert Johnen_US
dc.contributor.authorBrown, Simon G Aen_US
dc.contributor.authorWoodman, Richard Johnen_US
dc.contributor.authorPetrovsky, Nikolaien_US
dc.contributor.authorWiese, Michael Den_US
dc.date.accessioned2019-04-29T00:34:51Z
dc.date.available2019-04-29T00:34:51Z
dc.date.issued2019-04-09
dc.identifier.citationWanandy, T., Honda-Okubo, Y., Davies, N. W., Rose, H. E., Heddle, R. J., Brown, S. G. A., … Wiese, M. D. (2019). Pharmaceutical and preclinical evaluation of Advax adjuvant as a dose-sparing strategy for ant venom immunotherapy. Journal of Pharmaceutical and Biomedical Analysis, 172, 1–8. https://doi.org/10.1016/j.jpba.2019.04.017en_US
dc.identifier.issn0731-7085
dc.identifier.urihttp://hdl.handle.net/2328/39169
dc.description© 2019 Elsevier B.V. This manuscript version is made available under the CC-BY-NC-ND 4.0 license: http://creativecommons.org/licenses/by-nc-nd/4.0/ This author accepted manuscript is made available following 24 month embargo from date of publication (April 2019) in accordance with the publisher’s archiving policyen_US
dc.description.abstractA major challenge in broader clinical application of Jack Jumper ant venom immunotherapy (JJA VIT) is the scarcity of ant venom which needs to be manually harvested from wild ants. Adjuvants are commonly used for antigen sparing in other vaccines, and thereby could potentially have major benefits to extend JJA supplies if they were to similarly enhance JJA VIT immunogenicity. The purpose of this study was to evaluate the physicochemical and microbiological stability and murine immunogenicity of low-dose JJA VIT formulated with a novel polysaccharide adjuvant referred to as delta inulin or Advax™. Jack Jumper ant venom (JJAV) protein stability was assessed by UPLC-UV, SDS-PAGE, SDS-PAGE immunoblot, and ELISA inhibition. Diffraction light scattering was used to assess particle size distribution of Advax; pH and benzyl alcohol quantification by UPLC-UV were used to assess the physicochemical stability of JJAV diluent, and endotoxin content and preservative efficacy test was used to investigate the microbiological properties of the adjuvanted VIT formulation. To assess the effect of adjuvant on JJA venom immunogenicity, mice were immunised four times with JJAV alone or formulated with Advax adjuvant. JJA VIT formulated with Advax was found to be physicochemically and microbiologically stable for at least 2 days when stored at 4 and 25 °C with a trend for an increase in allergenic potency observed beyond 2 days of storage. Low-dose JJAV formulated with Advax adjuvant induced significantly higher JJAV-specific IgG than a 5-fold higher dose of JJAV alone, consistent with a powerful allergen-sparing effect. The pharmaceutical data provides important guidance on the formulation, storage and use of JJA VIT formulated with Advax adjuvant, with the murine immunogenicity studies providing a strong rationale for a planned clinical trial to test the ability of Advax adjuvant to achieve 4-fold JJAV dose sparing in JJA-allergic human patients.en_US
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.rights© 2019 Elsevier B.V.en_US
dc.subjectAdjuvantsen_US
dc.subjectAdvaxen_US
dc.subjectAllergyen_US
dc.subjectDelta inulinen_US
dc.subjectVenom immunotherapyen_US
dc.titlePharmaceutical and preclinical evaluation of Advax adjuvant as a dose-sparing strategy for ant venom immunotherapyen_US
dc.typeArticleen_US
dc.identifier.doihttps://doi.org/10.1016/j.jpba.2019.04.017en_US
dc.rights.holderElsevier B.V.en_US
local.contributor.authorOrcidLookupWanandy, Troy: https://orcid.org/0000-0003-4703-0488en_US
local.contributor.authorOrcidLookupPetrovsky, Nikolai: https://orcid.org/0000-0002-1580-5245en_US


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