Author: McMillan, Christopher L D ; Hobson-Peters, Jody ; Young, Paul R ; Muller, David A ; Vet, Laura J ; Watterson, Daniel ; Scott, Connor A P ; Harrison, Jessica J ; Hall, Roy A ; Fernando, Germain J P ; Choo, Jovin J Y ; Depelsenaire, Alexandra C I

AbstractDengue viruses (DENV) cause an estimated 390 million infections globally. With no dengue-specific therapeutic treatment currently available, vaccination is the most promising strategy for its control. A wide range of DENV vaccines are in development, with one having already been licensed, albeit with limited distribution. We investigated the immunogenicity and protective efficacy of a chimeric virus vaccine candidate based on the insect-specific flavivirus, Binjari virus (BinJV), displaying the structural prM/E proteins of DENV (BinJ/DENV2-prME). In this study, we immunized AG129 mice with BinJ/DENV2-prME via a needle-free, high-density microarray patch (HD-MAP) delivery system. Immunization with a single, 1 µg dose of BinJ/DENV2-prME delivered via the HD-MAPs resulted in enhanced kinetics of neutralizing antibody induction when compared to needle delivery and complete protection against mortality upon virus challenge in the AG129 DENV mouse model.

VaccinesQ3 · MEDICINE

Developing a Stabilizing Formulation of a Live Chimeric Dengue Virus Vaccine Dry Coated on a High-Density Microarray Patch

Q3 · MEDICINE

ArticleOA

Author: Fernando, Germain J P ; Hall, Roy A ; Hobson-Peters, Jody ; Young, Paul R ; Muller, David A ; McMillan, Christopher L D ; Choo, Jovin J Y

Alternative delivery systems such as the high-density microarray patch (HD-MAP) are being widely explored due to the variety of benefits they offer over traditional vaccine delivery methods. As vaccines are dry coated onto the HD-MAP, there is a need to ensure the stability of the vaccine in a solid state upon dry down. Other challenges faced are the structural stability during storage as a dried vaccine and during reconstitution upon application into the skin. Using a novel live chimeric virus vaccine candidate, BinJ/DENV2-prME, we explored a panel of pharmaceutical excipients to mitigate vaccine loss during the drying and storage process. This screening identified human serum albumin (HSA) as the lead stabilizing excipient. When bDENV2-coated HD-MAPs were stored at 4 °C for a month, we found complete retention of vaccine potency as assessed by the generation of potent virus-neutralizing antibody responses in mice. We also demonstrated that HD-MAP wear time did not influence vaccine deposition into the skin or the corresponding immunological outcomes. The final candidate formulation with HSA maintained ~100% percentage recovery after 6 months of storage at 4 °C.

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Indication	Highest Phase	Country/Location	Organization	Date
Dengue	Preclinical	AU	Vaxxas Pty Ltd.	07 May 2021
Dengue	Preclinical	AU	The University of Queensland	07 May 2021

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