End-user acceptability study of the nanopatch™; a microarray patch (MAP) for child immunization in low and middle-income countries

Guillermet, Élise; Alfa, Daleb Abdoulaye; Phuong, Le Thi; Subedi, Madhusudan; Démolis, Rachel; Giersing, Birgitte; Jaillard, Philippe

doi:10.1016/j.vaccine.2019.02.079

Cited by 23 publications

(39 citation statements)

References 18 publications

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“…The final product design is an integrated single use, autodisabling, and disposable applicator, and this will be used in the next clinical study. This design will reduce the overall system cost of the product for which, in the influenza market at least, needs to be competitive to a prefilled N&S. A prototype version of the commercial device has been evaluated in an end-user study conducted in Benin, Nepal, and Vietnam and was found to be very acceptable to immunisation managers, healthcare workers, community health volunteers, and caregivers [47]. The demonstration in this study that Vaxxas HD-MAPs fabricated from polymer rather than silicon can be manufactured and used for vaccine delivery is a significant advance.…”

Section: Discussionmentioning

confidence: 99%

“…Dose-sparing and rapid onset of protective immunity would also be a very valuable attribute for many other vaccines of global health importance such as inactivated poliovirus vaccine or yellow fever vaccine for which use is limited by chronic supply constraints [52][53][54], or by cost, such as rabies vaccine [55]. These vaccines are often needed most in low-resource settings where other key attributes of the Vaxxas HD-MAP, such as thermostability, ease of use, acceptability, and the avoidance of reconstitution would also be very beneficial [47].…”

Section: Discussionmentioning

confidence: 99%

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Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial

et al. 2020

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Background The Vaxxas high-density microarray patch (HD-MAP) consists of a high density of microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer the possibility of improved vaccine thermostability as well as the potential to be safer, more acceptable, easier to use, and more cost-effective for the administration of vaccines than injection by needle and syringe (N&S). Here, we report a phase I trial using the Vaxxas HD-MAP to deliver a monovalent influenza vaccine that was to the best of our knowledge the first clinical trial to evaluate the safety, tolerability, and immunogenicity of lower doses of influenza vaccine delivered by MAPs. Methods and findings HD-MAPs were coated with a monovalent, split inactivated influenza virus vaccine containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA). Between February 2018 and March 2018, 60 healthy adults (age 18-35 years) in Melbourne, Australia were enrolled into part A of the study and vaccinated with either: HD-MAPs delivering 15 μg of A/Singapore/ GP1908/2015 H1N1 HA antigen (A-Sing) to the volar forearm (FA); uncoated HD-MAPs; intramuscular (IM) injection of commercially available quadrivalent influenza vaccine (QIV) containing A/Singapore/GP1908/2015 H1N1 HA (15 μg/dose); or IM injection of H1N1 HA antigen (15 μg/dose). After 22 days' follow-up and assessment of the safety data, a further 150 healthy adults were enrolled and randomly assigned to 1 of 9 treatment groups.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial

et al. 2020

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“…Applicators activated by thumb pressure may have a better patient acceptance. Following this assumption, Vaxxas (Figure 1D) [14a] and Corium have designed applicators that only required thumb pressure once they are in contact with the skin.…”

Section: Microneedle Systemsmentioning

confidence: 99%

“…Boundaries are pushed to materialize new sophisticated technologies that enable more precision and better outcomes [1d−g,13] . For example, self‐applicable and pain‐free microneedle patches have shown promise in making vaccines more accessible, [ 14 ] and nanoparticles can improve sensitivity and selectivity in mass spectroscopy‐based analysis given their optical properties and high surface area. [ 15 ]…”

Section: Introductionmentioning

confidence: 99%

Engineering Micro–Nanomaterials for Biomedical Translation

Chen

Alba

Tieu

et al. 2021

Advanced NanoBiomed Research

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Engineered nano–bio interfaces–driven by vertical micro/nanoneedles, nanoparticles, organ‐on‐chip devices, and a diversity of nanosubstrates for mass spectroscopy imaging–are spurring scientific and technological progress, from fundamental to transnational biomedical research. Each class has its own characteristic features, which is critical for their translational uptake, but they broadly share the same range of functionality and applicability at the forefront of modern research and medicine. The review provides insights into unique attributes of microneedle technology and its ability for efficient transdermal transport of therapeutic compounds. The uses of nanoneedle technology in precise manipulation of increasingly complex cellular processes at the cell–material interface and their potential for major improvements for many fundamental research applications and ex vivo cell‐based therapies are highlighted. A snapshot in the use of food and drug administration (FDA)‐approved nanoparticle therapeutics and their applications in nanomedicine is provided. The achievements in organ‐on‐chip technology, particularly at the preclinical stage, and its potential to efficiently screen diverse types of therapeutics are covered. The final section is dedicated to the use of nanomaterial‐enhanced mass spectrometry in drug discovery and imaging. Overall, this review aims to highlight those main rules in the design of bio–nano interfaces that have successfully achieved translation into the market.

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“…A MAP consists of hundreds or thousands of projections, coated with or composed of dry vaccine formulation, on a ‘patch’ backing. The most clinically advanced vaccine MAPs either have no applicator, 54 or an integrated applicator 55 and when pressed on the skin, deliver the vaccine to the dermis or epidermis over seconds or a few minutes. MAPs are ‘pre-filled’, needle-free, single use presentations that reduce the risks of contamination, use of incorrect diluent or needle stick injuries.…”

Section: Situation Analysismentioning

confidence: 99%

Evolving pharmacovigilance requirements with novel vaccines and vaccine components

et al. 2021

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This paper explores the pipeline of new and upcoming vaccines as it relates to monitoring their safety. Compared with most currently available vaccines, that are constituted of live attenuated organisms or inactive products, future vaccines will also be based on new technologies. Several products that include such technologies are either already licensed or at an advanced stage of clinical development. Those include viral vectors, genetically attenuated live organisms, nucleic acid vaccines, novel adjuvants, increased number of antigens present in a single vaccine, novel mode of vaccine administration and thermostabilisation. The Global Advisory Committee on Vaccine Safety (GACVS) monitors novel vaccines, from the time they become available for large scale use. GACVS maintains their safety profile as evidence emerges from post-licensure surveillance and observational studies. Vaccines and vaccine formulations produced with novel technologies will have different safety profiles that will require adapting pharmacovigilance approaches. For example, GACVS now considers viral vector templates developed on the model proposed by Brighton Collaboration. The characteristics of those novel products will also have implications for the risk management plans (RMPs). Questions related to the duration of active monitoring for genetic material, presence of adventitious agents more easily detected with enhanced biological screening, or physiological mechanisms of novel adjuvants are all considerations that will belong to the preparation of RMPs. In addition to assessing those novel products and advising experts, GACVS will also consider how to more broadly communicate about risk assessment, so vaccine users can also benefit from the committee’s advice.

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End-user acceptability study of the nanopatch™; a microarray patch (MAP) for child immunization in low and middle-income countries

Cited by 23 publications

References 18 publications

Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial

Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial

Engineering Micro–Nanomaterials for Biomedical Translation

Evolving pharmacovigilance requirements with novel vaccines and vaccine components

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