Skin Delivery of the JVRS-100 Immunostimulant with and without Fluzone using a Protrusion Array Device (PAD) Results in Potent Adaptive Immune Responses (78.34)

Background: A protrusion array device (PAD) configured with hollow dissolvable microneedles was loaded with the JVRS-100 adjuvant or JVRS-100 combined with commercial Fluzone. The studies were designed to establish if adjuvant or adjuvant/vaccine could be administered via PAD patches. Methods: JVRS-100, Fluzone, or JVRS-100/Fluzone were loaded onto PAD patches and administered at day 0 and 14. At day 28 responses were assessed by HAI and ELISA (IgG, IgG1, and IgG2). Separate cohorts of mice were vaccinated intramuscularly (IM) with Fluzone and JVRS-100-containing patches were placed over the site of vaccination to see if intradermal administration of JVRS-100 would adjuvant IM vaccination. Results: The administration of JVRS-100 in addition to Fluzone stimulated a response greater than Fluzone alone patches as measured by geometric mean titer (EC₅₀) for IgG (4.8x10⁴ vs. 1.6x10⁴) and IgG2 (4.5x10³ vs 6.0x10²). IgG1 titers were elevated in the Fluzone only group compared with JVRS-100/Fluzone (8.3x10³ vs. 1.9x10³). Administration of JVRS-100-containing patches over IM Fluzone vaccination increased IgG (3.7x10⁵ vs. 2.2x10⁵) and IgG2a (1.5x10⁵ vs. 9.0x10⁴). IgG1 titers were elevated in the Fluzone-only group compared with JVRS-100/Fluzone (1.5x10⁵ vs. 2.9x10⁵). HAI levels correlated with antibody titer levels for all groups. Conclusion: The antibody response from both studies indicate that the T_H1 bias for JVRS-100 is retained as a dry PAD patch and intradermal administration over IM vaccination or combined for ID vaccination.