Abstract
BackgroundBetter delivery systems are needed for routinely used vaccines, to improve vaccine uptake. Many vaccines contain alum or alum based adjuvants. Here we investigate a novel dry-coated densely-packed micro-projection array skin patch (Nanopatch™) as an alternate delivery system to intramuscular injection for delivering an alum adjuvanted human papillomavirus (HPV) vaccine (Gardasil®) commonly used as a prophylactic vaccine against cervical cancer.Methodology/Principal FindingsMicro-projection arrays dry-coated with vaccine material (Gardasil®) delivered to C57BL/6 mouse ear skin released vaccine within 5 minutes. To assess vaccine immunogenicity, doses of corresponding to HPV-16 component of the vaccine between 0.43±0.084 ng and 300±120 ng (mean ± SD) were administered to mice at day 0 and day 14. A dose of 55±6.0 ng delivered intracutaneously by micro-projection array was sufficient to produce a maximal virus neutralizing serum antibody response at day 28 post vaccination. Neutralizing antibody titres were sustained out to 16 weeks post vaccination, and, for comparable doses of vaccine, somewhat higher titres were observed with intracutaneous patch delivery than with intramuscular delivery with the needle and syringe at this time point.Conclusions/SignificanceUse of dry micro-projection arrays (Nanopatch™) has the potential to overcome the need for a vaccine cold chain for common vaccines currently delivered by needle and syringe, and to reduce risk of needle-stick injury and vaccine avoidance due to the fear of the needle especially among children.
Highlights
Most vaccines are currently delivered by needle and syringe
We demonstrate dry coating and release of an alum adjuvanted human papillomavirus (HPV)-virus like particles (VLPs) vaccine with the NanopatchTM
Projection morphology of dry coated NanopatchesTM is suitable for needle penetration Coated patches were examined by scanning electron microscopy (SEM) using secondary electron and backscattered modes (Figure 2) to investigate the distribution of the coated vaccine along projections
Summary
As a vaccine delivery device, the needle and syringe has many important shortcomings These include potential transmission of blood borne diseases through needle-stick injuries [1] and needle reuse – approximately 30% of injections for the purpose of vaccination in developing nations are unsafe [2], and that needlestick injuries cause more than 500,000 deaths per year [3]. The NanopatchTM is a microprojection array with uniquely dense projection packing (.20,000/ cm2) and short projections (110 mm in length) This needle density was designed such that delivered vaccine has been co-localized with. We investigate a novel dry-coated densely-packed micro-projection array skin patch (NanopatchTM) as an alternate delivery system to intramuscular injection for delivering an alum adjuvanted human papillomavirus (HPV) vaccine (GardasilH) commonly used as a prophylactic vaccine against cervical cancer
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