Microprojection arrays to immunise at mucosal surfaces

McNeilly, Celia L.; Crichton, Michael L.; Primiero, Clare A.; Frazer, Ian H.; Roberts, Michael S.; Kendall, M. A. F.

doi:10.1016/j.jconrel.2014.09.028

Cited by 32 publications

(25 citation statements)

References 42 publications

(58 reference statements)

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“…Within the microneedle field, our work and that of others have demonstrated the need and challenges in placing vaccine in tightly defined skin locations 6 , particularly as the question of the ideal immune targeting location in the skin remains in debate 13 . Our work has previously shown that due to the disparity in the mechanical elastic modulus of skin’s constituent layers, entering the skin (or other tissue such as mucosae) in a way that is precise can be challenging 8 14 15 16 .…”

mentioning

confidence: 99%

The changing shape of vaccination: improving immune responses through geometrical variations of a microdevice for immunization

Crichton

Muller

Depelsenaire

et al. 2016

Sci Rep

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Micro-device use for vaccination has grown in the past decade, with the promise of ease-of-use, painless application, stable solid formulations and greater immune response generation. However, the designs of the highly immunogenic devices (e.g. the gene gun, Nanopatch or laser adjuvantation) require significant energy to enter the skin (30–90 mJ). Within this study, we explore a way to more effectively use energy for skin penetration and vaccination. These modifications change the Nanopatch projections from cylindrical/conical shapes with a density of 20,000 per cm2 to flat-shaped protrusions at 8,000 per cm2, whilst maintaining the surface area and volume that is placed within the skin. We show that this design results in more efficient surface crack initiations, allowing the energy to be more efficiently be deployed through the projections into the skin, with a significant overall increase in penetration depth (50%). Furthermore, we measured a significant increase in localized skin cell death (>2 fold), and resultant infiltrate of cells (monocytes and neutrophils). Using a commercial seasonal trivalent human influenza vaccine (Fluvax 2014), our new patch design resulted in an immune response equivalent to intramuscular injection with approximately 1000 fold less dose, while also being a practical device conceptually suited to widespread vaccination.

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mentioning

confidence: 99%

The changing shape of vaccination: improving immune responses through geometrical variations of a microdevice for immunization

Crichton

Muller

Depelsenaire

et al. 2016

Sci Rep

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“…They have also been used to deliver a broad range of antigen and adjuvant combinations. Although specific studies of microneedle‐mediated vaccine delivery to the oral mucosa are limited, several recent studies suggest that microneedles could overcome the limitations of previous dosage forms to improve our understanding of oral mucosal immunity and ultimately improve vaccine delivery to the oral cavity …”

Section: Microneedles Have Broad Capabilities That Could Improve Oralmentioning

confidence: 99%

“…Without a firm backing to provide support, tissue may be more likely to bend around needles rather than puncture . Existing oral mucosal microneedle vaccine studies have demonstrated variable needle penetration and dosing efficiency . Design of applicators for oral mucosal microneedle vaccination could improve the delivery efficiency and uniformity to previously evaluated tissues such as the buccal region and the tongue.…”

Section: Microneedles Have Broad Capabilities That Could Improve Oralmentioning

confidence: 99%

“…Even so, the minimal immune responses generated by the microneedle system compared to subcutaneous delivery suggest further exploration of different adjuvants that could improve efficacy. Given that responses comparable to intramuscular delivery have been induced without any adjuvant, it is plausible that incorporation of adjuvants in oral mucosal microneedle systems could greatly improve the quality and quantity of mucosal and systemic immune responses, as has been observed for topical dosage forms. The delivery capabilities of microneedles could also improve our understanding of adjuvant behavior in the oral mucosa.…”

Section: Perspectives and Outlookmentioning

confidence: 99%

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Microneedle‐Mediated Vaccine Delivery to the Oral Mucosa

Creighton

Woodrow

2018

Adv Healthcare Materials

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The oral mucosa is a minimally invasive and immunologically rich site that is underutilized for vaccination due to physiological and immunological barriers. To develop effective oral mucosal vaccines, key questions regarding vaccine residence time, uptake, adjuvant formulation, dose, and delivery location must be answered. However, currently available dosage forms are insufficient to address all these questions. An ideal oral mucosal vaccine delivery system would improve both residence time and epithelial permeation while enabling efficient delivery of physicochemically diverse vaccine formulations. Microneedles have demonstrated these capabilities for dermal vaccine delivery. Additionally, microneedles enable precise control over delivery properties like depth, uniformity, and dosing, making them an ideal tool to study oral mucosal vaccination. Select studies have demonstrated the feasibility of microneedle‐mediated oral mucosal vaccination, but they have only begun to explore the broad functionality of microneedles. This review describes the physiological and immunological challenges related to oral mucosal vaccine delivery and provides specific examples of how microneedles can be used to address these challenges. It summarizes and compares the few existing oral mucosal microneedle vaccine studies and offers a perspective for the future of the field.

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“… 12 , 13 , 14 , 15 , 16 Among them, the Nanopatch™ is a microprojection vaccine delivery technology that has been successfully engineered and tested in preclinical studies for several vaccines. 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 The Nanopatch™ consists of a 1 cm 2 silicon chip-like patch with a high-density (over 20,000 microprojections per cm 2 ) array on the skin-facing surface. 2 , 27 When vaccine-coated devices are applied to the skin, the Nanopatch™ reproducibly targets the vaccine to thousands of antigen-presenting cells in both the viable epidermal and dermal layers of the skin.…”

Section: Introductionmentioning

confidence: 99%

Development of Stabilizing Formulations of a Trivalent Inactivated Poliovirus Vaccine in a Dried State for Delivery in the Nanopatch™ Microprojection Array

Wan

Hickey

Bird

et al. 2018

Journal of Pharmaceutical Sciences

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The worldwide switch to inactivated polio vaccines (IPVs) is a key component of the overall strategy to achieve and maintain global polio eradication. To this end, new IPV vaccine delivery systems may enhance patient convenience and compliance. In this work, we examine Nanopatch™ (a solid, polymer microprojection array) which offers potential advantages over standard needle/syringe administration including intradermal delivery and reduced antigen doses. Using trivalent IPV (tIPV) and a purpose-built evaporative dry-down system, candidate tIPV formulations were developed to stabilize tIPV during the drying process and on storage. Identifying conditions to minimize tIPV potency losses during rehydration and potency testing was a critical first step. Various classes and types of pharmaceutical excipients (∼50 total) were then evaluated to mitigate potency losses (measured through D-antigen ELISAs for IPV1, IPV2, and IPV3) during drying and storage. Various concentrations and combinations of stabilizing additives were optimized in terms of tIPV potency retention, and 2 candidate tIPV formulations containing cyclodextrin and a reducing agent (e.g., glutathione), maintained ≥80% D-antigen potency during drying and subsequent storage for 4 weeks at 4°C, and ≥60% potency for 3 weeks at room temperature with the majority of losses occurring within the first day of storage.

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Microprojection arrays to immunise at mucosal surfaces

Cited by 32 publications

References 42 publications

The changing shape of vaccination: improving immune responses through geometrical variations of a microdevice for immunization

The changing shape of vaccination: improving immune responses through geometrical variations of a microdevice for immunization

Microneedle‐Mediated Vaccine Delivery to the Oral Mucosa

Development of Stabilizing Formulations of a Trivalent Inactivated Poliovirus Vaccine in a Dried State for Delivery in the Nanopatch™ Microprojection Array

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