Vaccine microarray patch self-administration: A preliminary study in adults 50 years of age and over

• Published in: Vaccine Vol. 48; p. 126699
• Main Authors: Davies, C., Baker, B., Berger, M.N., Knox, S.L., Mowbray, E., Stewart, B.G., Booy, R., Hacker, E., Marmol, A., Ross, C., Muller, D.A., Mortimore, A.M., Siller, G., Forster, A.H., Skinner, S.R.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 27.02.2025; Elsevier Limited
• Subjects: Acceptability; Adults; Aged; Aged, 80 and over; Allergy and Immunology; applicators; arms (limbs); Australia; Consent; Cost control; descriptive statistics; Effectiveness; Female; females; Fluorescence; High-density microarray patch; Humans; Immunization; Influenza; intramuscular injection; Male; males; Microarray patch; microarray technology; Middle Aged; Older adults; Older people; Patient Acceptance of Health Care; Qualitative research; Safety; Self Administration - methods; Self-administration; Selfadministration; Skin; Software; Statistical analysis; surveys; Transdermal Patch; Usability; Vaccination; Vaccination - methods; Vaccine; Vaccines; Vaccines - administration & dosage; Water loss; Australia; Queensland Australia; Germany; TEWL; High-density microarray patch; Vaccination; Vaccine; UA; Older adults; Acceptability; Microarray patch; Selfadministration; IFU; Adults; Safety; HD-MAP; FA; Usability; MAP; Instructions for use; Transepidermal water loss; Volar forearm; High-Density Micorarry Patch; Upper arm
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2024.126699

We assessed the safety, performance, acceptability, and usability of the High-Density Microarray Patch (HD-MAP) for vaccination in adults aged 50 and over. This study was a single-centre, open-label, single-arm intervention in healthy adults aged 50+. HD-MAPs (vaccine-free) were applied by a trained user and self-administered. Participants received one excipient-coated HD-MAP to the volar forearm (FA) and the upper arm (UA) administered by a trained user. Participants then self-administered a HD-MAP to the FA and UA. Application sites were compared for skin response. Participants completed an online survey and participated in a semi-structured interview on acceptability and usability. Analyses were undertaken using descriptive statistics. Interviews were coded in NVivo 12 and subject to thematic analysis. The study occurred from 8 September 2021 to 15 February 2022 in Brisbane, Australia. Of 44 participants, 43 % (n = 19) were male, and 57 % (n = 25) female. The HD-MAP was well-tolerated, with no treatment-related serious adverse events. The increase in transepidermal water loss following self-administration was similar to that observed for trained user administration (UA: 7.5 fold vs 6-fold, FA: 6.1-fold vs 6.6 fold). Fluorescent dermatoscopy confirmed that HD-MAPs engaged with the skin surface and that self and trained user administrations were similar. All participants found the HD-MAP applicator easy to use. 82 % of participants preferred “vaccination” by HD-MAP should its efficacy be proven equivalent to intramuscular injection (IM). Participants reported high acceptance of the resulting transient marks on the skin (82 %). 98 % of participants agreed that self-administration of the HD-MAP at home, without supervision, was highly preferable for its convenience. HD-MAPs were safe in adults 50+ years, and performance was effective, regardless of administrator. Participants preferred the HD-MAP for its ease of use and convenience in self-administration. This vaccine delivery method shows promise for future implementation for this population.