1. High-density microarray patches (HD-MAPs) for influenza vaccination were well-tolerated and resulted in similar or improved immune response at one-sixth the standard dose compared to intramuscular injection of commercial quadrivalent influenza vaccine.
Evidence Rating Level: 2 (Good)
Microarray patches (MAPs) are advantageous compared to needle injection of vaccination due to greater acceptability, ease of use, and vaccine thermostability. This randomized, partially-blind, placebo-controlled Phase I clinical trial investigated the safety, tolerability, and immunogenicity of the Vaxxas high-density MAP (HD-MAP) in delivering a monovalent influenza vaccine. A total of 60 healthy adults from Melbourne, Australia aged 18 to 35 years were enrolled in this study. HD-MAPs had monovalent, split inactivated vaccine coating containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA). Participants were randomly assigned to one of the following: 1) HD-MAPs delivering 15μg of A/Singapore/GP1908/2015 H1N1 HA antigen (A-Sing) to volar forearm (FA); 2) uncoated HD-MAPs; 3) intramuscular (IM) injection of commercial quadrivalent influenza vaccine (QIV) containing A-Sing at 15μg/dose; or, 4) IM injection of H1N1 HA antigen at 15μg/dose. After a 22-day follow-up to assess safety, there was enrollment of 150 adult participants randomized to one of nine total treatment groups. These groups were HD-MAPs at doses of 15, 10, 5, 2.5, or 0 μg of HA to the FA, the same vaccinations in the upper arm (UA, or IM injection of QIV. Researchers found that vaccines coated with HD-MAPs were antigenically stable at 40ºC for a minimum of 12 months. HD-MPA was also safe and well-tolerated with limited mild-to-moderate adverse effects including myalgia and headache. HD-MAP resulted in improved humoral responses compared with IM injection with higher HAI geometric mean titers (GMTs) at Day 8 in the MAP-UA-15 group (GMT 437.1, 95% CI 133.2 to 441.5), MAP-FA-15 (GMT 218.6, 95% CI 111.0 to 427.0), and MAP-FA-10 (GMT 437.1, 95% CI 254.3 to 751.3) compared to IM-QIV-15 (GMT 82.8, 95% CI 42.4 to 161.8. Significance levels for MAP-UA-15, MAP-FA-15, and MAP-FA-10 were 0.02, 0.04, and <0.001, respectively. Higher titers were noted at Day 22 in the MAP-FA-10 (GMT 485.0, 95% CI 301.5 to 780.2) and MAP-UA-15 (GMT 367.6, 95% CI 197.9 to 682.7) groups compared to the IM-QIV-15 group (GMT 139.3, 95% CI 79.3 to 244.5). Overall, Vaxxas HD-MAP resulted in immune responses equivalent to or higher than those resulting from IM-QIV injection. Further, HD-MAP required one-sixth the standard dose – 2.5μg induced HAI and MN titers to achieve the same results as 15μg HA-IM.
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