Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings

Abstract

Background High-density microarray patch (HD-MAP) vaccines may increase vaccine acceptance and use. We aimed to ascertain whether professional immunizers (PIs) and other healthcare workers (HCWs) in Australia, a High-Income Country (HIC), found the HD-MAP applicator usable and acceptable for vaccine delivery. Methods This feasibility study recruited PIs and HCWs to administer/receive simulated HD-MAP administration, including via self-administration. We assessed usability against essential and desirable criteria. Participants completed a survey, rating their agreement to statements about HD-MAP administration. A subset also participated in an interview or focus group. Survey data were analyzed using descriptive statistics, and interviews were transcribed and subject to thematic analysis. Results We recruited 61 participants: 23 PIs and 38 HCWs. Findings indicated high usability and acceptability of HD-MAP use across both groups by a healthcare professional or trained user and for self-administration with safety measures in place. Most administrations met essential criteria, but PIs, on average, applied the HD-MAP for slightly less time than the required 10-seconds, which the HCWs achieved. PIs perceived safety concerns about home administration but found layperson self-administration acceptable in an emergency, pandemic, and rural or remote settings. Conclusions Participants found HD-MAP administration usable and acceptable. Usability and acceptability are likely to be improved through end-user education and training.

Immunogenicity, safety, usability and acceptability of microarray patches for vaccination: a systematic review and meta-analysis

“…Confidence in correct administration was relatively low, with only half of the participants in two clinical studies confident that the MAP would have worked in general 38 43. However, in another study, all participant groups were confident that they correctly self-administered a MAP 45. Two studies suggested a visual indicator to confirm a correct MAP dose delivery as an improvement to MAP design, which was reported by all laypeople and most HCPs 48 49.…”

“…Quantitative and qualitative data explored usability and acceptability. Across several studies, HCPs, HCWs and laypeople found MAPs very easy to use 15 44 45. One clinical study in the USA compared MAPs with and without a snap-based device, each administered three times 8.…”

“…An Australian simulation study using MAP applicators without patches assessed wear time (the application time required for MAP vaccination), with HCPs meeting the required 10 s about a third of the time compared with HCWs achieving more than half of the time 45. Wear time was observed in clinical studies ranging from 10 s to 2 min, with qualitative data suggesting up to 10 min would be acceptable 15 46 47.…”

Opportunities and challenges for commercializing microarray patches for vaccination from a MAP developer’s perspective

“…Several usability studies have been published indicating the general ease of use of Vaxxas MAP technology in both low/middle income and high-income countries, but both studies also highlighted the need for significant user education around technology introduction. 22 , 23 …”

Local Response and Barrier Recovery in Elderly Skin Following the Application of High-Density Microarray Patches

“…We have experience with a high-density microarray patch (HD-MAP) vaccine delivery platform. The HD-MAP applied to the skin provides practical advantages, including the absence of sharps, a reduced dependence or total removal from the cold chain, and the possibility for self-application through the use of a disposable applicator [5][6][7]. The HD-MAP delivers the vaccine antigen to the epidermal and dermal layers of the skin containing a high density of dendritic cells.…”