Explore the vast range of titles available.

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.

Microarray patches (MAPs) have the potential to be a safer, more acceptable, easier-to-use, and more cost-effective means for the administration of vaccines than injection by needle and syringe. Here, we report findings from a randomized, partially double-blinded, placebo-controlled Phase I trial using the Vaxxas high-density MAP (HD-MAP) to deliver a measles rubella (MR) vaccine. Healthy adults (N = 63, age 18–50 years) were randomly assigned 1:1:1:1 to four groups: uncoated (placebo) HD-MAPs, low-dose MR HD-MAPs (~3100 median cell-culture infectious dose [CCID50] measles, ~4300 CCID50 rubella); high-dose MR-HD-MAPs (~9300 CCID50 measles, ~12,900 CCID50 rubella); or a sub-cutaneous (SC) injection of an approved MR vaccine, MR-Vac (≥1000 CCID50 per virus). The MR vaccines were stable and remained viable on HD-MAPs when stored at 2–8 °C for at least 24 months. When MR HD-MAPs stored at 2–8 °C for 24 months were transferred to 40 °C for 3 days in a controlled temperature excursion, loss of potency was minimal, and MR HD-MAPs still met World Health Organisation (WHO) specifications. MR HD-MAP vaccination was safe and well-tolerated; any systemic or local adverse events (AEs) were mild or moderate. Similar levels of binding and neutralizing antibodies to measles and rubella were induced by low-dose and high-dose MR HD-MAPs and MR-Vac. The neutralizing antibody seroconversion rates on day 28 after vaccination for the low-dose HD-MAP, high-dose HD-MAP and MR-Vac groups were 37.5%, 18.8% and 35.7%, respectively, for measles, and 37.5%, 25.0% and 35.7%, respectively, for rubella. Most participants were seropositive for measles and rubella antibodies at baseline, which appeared to negatively impact the number of participants that seroconverted to vaccines delivered by either route. The data reported here suggest HD-MAPs could be a valuable means for delivering MR-vaccine to hard-to-reach populations and support further development. Clinical trial registry number: ACTRN12621000820808.

Background: Vaccination is a fundamental tenet of public and population health. Several barriers to vaccine uptake exist, exacerbated post-COVID-19, including misconceptions about vaccine efficacy and safety, vaccine hesitancy, vaccine inequity, costs, religious beliefs, and insufficient education and guidance for healthcare professionals. Vaccine uptake may be aided using microarray patches (MAPs) due to reduced pain, no hypodermic needle, enhanced thermostability, and potential for self and lay administration. Objectives: This protocol outlines the development of a scale that aims to accurately measure the perceived safety, usability, and acceptability of MAPs for vaccination among laypeople, MAP recipients, clinicians, and parents or guardians of children. Methods and analysis: This study will follow three phases of scale development and validation, including (1) item development, (2) scale development, and (3) scale evaluation. Inductive (interviews) and deductive methods (literature searches) will be used to develop scale items, which experts from target populations will assess through an online survey. Cognitive interviews will be conducted to observe their processes of answering the draft survey. Thematic analysis will be conducted to analyse qualitative data. Lastly, four surveys will be administered online to our target populations over two time points to determine their repeatability. Exploratory and confirmatory factor analyses, Cronbach’s alpha, and construct validity will be performed. Ethics: This study was approved by Metro South Health (HREC/2021/QMS/81653) and Western Sydney Local Health District (2023/ETH00705) Human Research Ethics Committees. Discussion: The scale will support a standardised approach to assessing the social and behavioural aspects of MAP vaccines, enabling comparison of outcomes across studies. Once validated, this scale will assist vaccination programmes in developing effective strategies for integrating MAPs and overcoming barriers to vaccination. This includes improving vaccine equity and accessibility, especially in lower- and middle-income countries and rural or remote locations.

Injection using needle and syringe (N&S) is the most widely used method for vaccination, but requires trained healthcare workers. Fear of needles, risk of needle-stick injury, and the need to reconstitute lyophilised vaccines, are also drawbacks. The Nanopatch (NP) is a microarray skin patch comprised of a high-density array of microprojections dry-coated with vaccine that is being developed to address these shortcomings. Here we report a randomised, partly-blinded, placebo-controlled trial that represents the first use in humans of the NP to deliver a vaccine. Healthy volunteers were vaccinated once with one of the following: (1) NPs coated with split inactivated influenza virus (A/California/07/2009 [H1N1], 15 µg haemagglutinin (HA) per dose), applied to the volar forearm (NP-HA/FA), n = 15; (2) NPs coated with split inactivated influenza virus (A/California/07/2009 [H1N1], 15 µg HA per dose), applied to the upper arm (NP-HA/UA), n = 15; (3) Fluvax® 2016 containing 15 µg of the same H1N1 HA antigen injected intramuscularly (IM) into the deltoid (IM-HA/D), n = 15; (4) NPs coated with excipients only, applied to the volar forearm (NP-placebo/FA), n = 5; (5) NPs coated with excipients only applied to the upper arm (NP-placebo/UA), n = 5; or (6) Saline injected IM into the deltoid (IM-placebo/D), n = 5. Antibody responses at days 0, 7, and 21 were measured by haemagglutination inhibition (HAI) and microneutralisation (MN) assays. NP vaccination was safe and acceptable; all adverse events were mild or moderate. Most subjects (55%) receiving patch vaccinations (HA or placebo) preferred the NP compared with their past experience of IM injection with N&S (preferred by 24%). The antigen-vaccinated groups had statistically higher HAI titres at day 7 and 21 compared with baseline (p < 0.0001), with no statistical differences between the treatment groups (p > 0.05), although the group sizes were small. The geometric mean HAI titres at day 21 for the NP-HA/FA, NP-HA/UA and IM-HA/D groups were: 335 (189–593 95% CI), 160 (74–345 95% CI), and 221 (129–380 95% CI) respectively. A similar pattern of responses was seen with the MN assays. Application site reactions were mild or moderate, and more marked with the influenza vaccine NPs than with the placebo or IM injection. Influenza vaccination using the NP appeared to be safe, and acceptable in this first time in humans study, and induced similar immune responses to vaccination by IM injection.

The high-density microprojection array patch (HD-MAP) is a novel vaccine delivery system with potential for self-administered vaccination. HD-MAPs provide an alternative to needle and syringe (N&S) vaccination. Additional advantages could include reduced cold-chain requirements, reduced vaccine dose, reduced vaccine wastage, an alternative for needle phobic patients and elimination of needlestick injuries. The drivers and potential benefits of vaccination by self-administering HD-MAPs are high patient acceptance and preference, higher vaccination rates, speed of roll-out, cost-savings, and reduced sharps and environmental waste. The HD-MAP presents a unique approach in pandemic preparedness and routine vaccination of adults. It could alleviate strain on the healthcare workforce and allows vaccine administration by minimally-trained workers, guardian or subjects themselves. Self-vaccination using HD-MAPs could occur in vaccination hubs with supervision, at home after purchasing at the pharmacy, or direct distribution to in-home settings. As a result, it has the potential to increase vaccine coverage and expand the reach of vaccines, while also reducing labor costs associated with vaccination. Key challenges remain around shifting the paradigm from medical professionals administrating vaccines using N&S to a future of self-administration using HD-MAPs. Greater awareness of HD-MAP technology and improving our understanding of the implementation processes required for adopting this technology, are critical factors underpinning HD-MAP uptake by the public.

Microarray patches (MAPs), also referred to as microneedle patches, are a novel methodology that have the potential to overcome barriers to vaccine delivery in low- and middle-income countries (LMICs), and transform the way that vaccines are delivered within immunization programs. The World Health Organization’s Initiative for Vaccine Research and its partners are working to understand how MAPs could ease vaccine delivery and increase equitable access to vaccines in LMICs. Global stakeholders have been engaged to evaluate technical, economic, and programmatic challenges; to validate assumptions where possible; and to propose areas of focus to facilitate future vaccine-MAP product development. This report summarizes those learnings.

PurposeWhilst significant progress has been made to defeat HIV infection, the efficacy of antiretroviral (ARV) therapy in the paediatric population is often hindered by poor adherence. Currently, two long-acting (LA) intramuscular injectable nanosuspensions of rilpivirine (RPV) and cabotegravir (CAB) are in clinical development for paediatric populations. However, administration requires access to healthcare resources, is painful, and can result in needle-stick injuries to the end user. To overcome these barriers, this proof-of-concept study was developed to evaluate the intradermal delivery of RPV LA and CAB LA via self-disabling dissolving microarray patches (MAPs).MethodsDissolving MAPs of two conformations, a conventional pyramidal and a bilayer design, were formulated, with various nanosuspensions of RPV and CAB incorporated within the respective MAP matrix. MAPs were mechanically robust and were capable of penetrating ex vivo skin with intradermal ARV deposition.ResultsIn a single-dose in vivo study in rats, all ARV MAPs demonstrated sustained release profiles, with therapeutically relevant plasma concentrations of RPV and CAB detected to at least 63 and 28 d, respectively. In a multi-dose in vivo study, repeated MAP applications at 14-d intervals maintained therapeutically relevant plasma concentrations throughout the duration of the study.ConclusionsThese results illustrate the potential of the platform to repeatedly maintain plasma concentrations for RPV and CAB. As such, these MAPs could represent a viable option to improve adherence in the paediatric population, one that is capable of being painlessly administered in the comfort of the patient’s own home on a biweekly or less frequent basis.

Microneedle (MN) technologies offer the opportunity to improve patient access and target delivery of drugs and vaccines to specific tissues. When in the form of skin patches, MNs can be administered by personnel with minimal training, or could be self-administered by patients, which can improve access to medication, especially those usually requiring injection. Because MNs are small (usually sub-millimetre), they can be used for precise tissue targeting. MN patches have been extensively studied to administer vaccines and drugs in preclinical work as well as in multiple clinical trials. When formulated with biodegradable polymer, MNs can enable long-acting therapies by slowly releasing drug as the MNs biodegrade. Targeted drug delivery by hollow MNs has resulted in FDA-approved products that are able to inject vaccines to skin-resident immune cells to improve immune response and to target specific parts of the eye (e.g., suprachoroidal space) for increased efficacy and avoidance of side effects in other parts of the eye. Cosmetic products based on MN technologies are already in widespread use, mostly as anti-aging agents. With extensive research coupled with FDA-approved products, MN technology promises to continue is growth in research leading to products that can benefit patients.

Vaccination is a crucial element of public and population health. Microarray patches (MAPs) may improve vaccine uptake due to reduced pain, being needle-free, enhanced thermostability, and potential for self or lay administration. We aimed to validate a scale that measures perceptions of MAP vaccine safety, usability, and acceptability in adults aged 18+. This study followed the three phases of scale development and validation. Phase 1 comprised a literature review and key stakeholder cognitive interviews (n = 10) to identify potential and additional scale items. Experts (n = 14) scored the draft scale for face and content validity. In phase 2 further cognitive interviews (n = 27) and exploratory factor analyses determined content validity, informing the addition, adjustment, or deletion of draft items. In phase 3 reliability testing was undertaken by administering two online surveys at least two weeks apart to determine the consistency of participant scores across time and to examine internal consistency. A draft 32-item scale was developed and assessed by experts and key stakeholder cognitive interviews. The final ‘MAPVac’ scale consisted of 20 items. A total of 206 participants from the general public completed online surveys across Australia and New Zealand (n = 92, 44.7 %), Canada (n = 87, 42.2 %), and the United Kingdom (n = 27, 13.1 %). A four-factor model was determined by exploratory factor analysis, which encompassed general positive attitude questions around MAP vaccination achieving its desired outcome, MAP delivery, self and lay administration, and side effects including perceived discomfort. The MAPVac scale demonstrated high internal consistency (Cronbach's alpha = 0.90) and considerable repeatability, with all scale items demonstrating moderate positive correlations at both administrations (Spearman's r = 0.40–0.61). The MAPVac scale is a reliable and valid approach to assessing MAP vaccines' social and behavioural aspects. This scale may assist vaccination programs in developing effective strategies for integrating MAPs and overcoming barriers to vaccination. •Microarray patches (MAPs) for vaccination are a needle-less vaccine delivery platform.•We aimed to develop and validate the Microarray Patch for Vaccination (MAPVac) scale.•MAPVac scale is an accurate measure for perceived safety, usability and acceptability.•Participants found MAPs to be safe, easy to use, and acceptable.

Vaccination is crucial for public and population health. Microarray patches (MAPs) could enhance vaccine uptake through reduced pain, no needles, improved thermostability and self or lay administration, but there is limited evidence. We aimed to investigate the perceptions of the general public and healthcare professionals (HCPs) aged 18 years and older about MAP vaccination. This mixed-methods study was part of a project to validate a scale measuring MAP vaccination's safety, usability, and acceptability. Online surveys and semi-structured interviews were conducted in Australia, Canada, United Kingdom, and New Zealand. 7-point Likert scale items were scaled from “strongly disagree” to “strongly agree” and analysed using descriptive statistics (e.g., means and confidence intervals (CI)). Interviews were transcribed verbatim, coded, and analysed using thematic analysis. In the survey group, 403 general public and 184 HCPs responded. We interviewed 27 participants (12 general public and 15 HCPs). The general public and HCPs perceived MAPs as safe and efficacious, with means of 5.00 (95 % CI: 4.85–5.14) and 4.92 (95 % CI: 4.71–5.12) respectively. The general public (mean = 5.58, 95 % CI: 5.46–5.70) and HCPs (mean = 5.75, 95 % CI: 5.59–5.92) perceived MAPs as usable. Lastly, the general public (mean = 5.49, 95 % CI: 5.37–5.61) and HCPs (mean = 5.30, 95 % CI: 5.12–5.50) perceived MAPs as acceptable. Participants widely perceived MAPs as safe and easy to use due to their ‘straightforward’ instructions, including for self-administration. All participants regarded MAPs as advantageous for children and needle-phobic individuals. Some HCPs were concerned about possible adverse events at home (i.e., anaphylaxis), but were interested in incorporating MAPs in their clinical practice. Microarray patches (MAPs) MAPs are viewed by the general public and HCPs as safe, user-friendly, and well-received as alternatives to needle and syringe vaccination for greater acceptability among consumers. MAPS may also improve access to vaccination in priority populations and areas with limited resources. •Microarray patches (MAPs) are needle-less vaccine delivery platforms in development.•We explored safety, usability, and acceptability among laypeople and clinicians.•General public and clinicians found MAPs to be safe, easy to use, and acceptable.•Clinicians were interested in incorporating MAPs into their practice.