Abstract
Abstract A safe, effective, easily administered, and storage-stable anti-malarial vaccine delivery platform would improve vaccination efforts in populations at risk for malaria. Painless, self-blunting soluble microneedle arrays seem ideal for skin-based inoculation. To test the ability of adjuvanted microneedle arrays to induce an immune response, anti-malarial circumsporozoite surface protein (CSP) antigen was delivered directly to skin by water-soluble polyvinyl alcohol microneedles, inducing a robust and specific immune response in BALB/c mouse cohorts. Inclusion of JVRS-100 cationic lipid DNA complex adjuvant boosted immune response and dried arrays induced strong response even after exposure to accelerated thermal storage conditions. To assess storage stability of the needle array dosage form, loaded microneedle arrays and parallel antigen solutions were subjected to one-week storage at 20°, 37°, and 50°C, and subsequently used to inoculate mouse cohorts. Serum anti-CSP IgG titers indicated that while antigen solutions showed profound (10-fold) loss of activity with increasing storage temperature, the dry arrays exhibited no such degradation.
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