Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial

Beals, Chan R.; Railkar, Radha; Schaeffer, Andrea; Levin, Yotam; Kochba, Efrat; Meyer, Brian K.; Evans, Robert K.; Sheldon, Eric; Lasseter, Kenneth C.; Lang, Nancy; Weinberg, Adriana; Canniff, Jennifer; Levin, Myron J.

doi:10.1016/s1473-3099(16)00133-x

Cited by 42 publications

(25 citation statements)

References 23 publications

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“…In order to promote a regulatory response to the PIC19-A3 autoantigen we employed the CE-marked MJ600 device to target skin DCs whilst minimising the trauma of intradermal delivery and any ensuing cutaneous inflammation (Mutyambizi et al, 2009). The device has three hollow silicon MNs of 600μm length and has been used extensively in clinical studies to deliver a range of macromolecular formulations including insulin (Kochba et al, 2016), varicella zoster (Beals et al, 2016), polio (Anand et al, 2015;Troy et al, 2015) and seasonal and pandemic influenza vaccines (Della Cioppa et al, 2014;Hung et al, 2012a;Hung et al, 2012b;Levin et al, 2014;Levin et al, 2016;Van Damme et al, 2009). However, whilst there are a number of publications showing successful therapeutic readouts upon use of hollow MNs, there is a paucity of information related to the behaviour of injected materials in the local environment and how formulation or physicochemical drug properties influence distribution and retention in situ (Mansoor et al, 2015).…”

Section: Resultsmentioning

confidence: 99%

“…dissolution of the peptide in the biological milieu. As an alternative, hollow MNs provide a clinically approved (Beals et al, 2016;Bragazzi et al, 2016) system that uses either single needles or a plurality of microstructures for delivery of a discrete volume of a liquid formulation into the intradermal space. The MicronJet600 device, from NanoPass Technologies Ltd, is a hollow CE-marked MN device for clinical use and has stimulated robust immune responses to vaccines (Levin et al, 2015) at potentially reduced antigen doses.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Conjugation of a peptide autoantigen to gold nanoparticles for intradermally administered antigen specific immunotherapy

Dul

Nikolić

Stefanidou

et al. 2019

International Journal of Pharmaceutics

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Antigen specific immunotherapy aims to tolerise patients to specific autoantigens that are responsible for the pathology of an autoimmune disease. Immune tolerance is generated in conditions where the immune response is supressed and thus gold nanoparticles (AuNPs) are an attractive drug delivery platform due to their anti-inflammatory effects and their potential to facilitate temporal and spatial delivery of a peptide autoantigen in conjunction with pro-tolerogenic elements. In this study we have covalently attached an autoantigen, currently under clinical evaluation for the treatment of type 1 diabetes (PIC19-A3 peptide), to AuNPs to create nanoscale (<5nm), negatively charged (-40 to-60mV) AuNP-peptide complexes for immunotherapy. We also employ a clinically approved microneedle delivery system, MicronJet600, to facilitate minimally-invasive intradermal delivery of the nanoparticle constructs to target skin-resident antigen presenting cells, which are known to be apposite target cells for immunotherapy. The AuNP-peptide complexes remain physically stable upon extrusion through microneedles and when delivered into ex vivo human skin they are able to diffuse rapidly and widely throughout the dermis (their site of deposition) and, perhaps more surprisingly, the overlying epidermal layer. Intracellular uptake was extensive, with Langerhans cells proving to be the most efficient cells at internalising the AuNP-peptide complex (94% of the local population within the treated region of skin). In vitro studies showed that uptake of the AuNP-peptide complexes by dendritic cells reduced the capacity of these cells to activate naïve T cells. This indicator of biological functionality encourages further development of the AuNP-peptide formulation, which is now being evaluated in clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Conjugation of a peptide autoantigen to gold nanoparticles for intradermally administered antigen specific immunotherapy

Dul

Nikolić

Stefanidou

et al. 2019

International Journal of Pharmaceutics

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“…The MicronJet has also been studied for reduceddose delivery of IPV 362,363 and varicella-zoster vaccine. 364 Another hollow microneedle system is 3M's hollow microstructured transdermal system (hMTS). 289,369 Its patient-contact surface contains 18 microneedles of 500 to 900 µm in height, whose lumina of 10 to 40 µm in diameter delivers liquid volumes ranging from 0.3 to 1.5 mL.…”

Section: Needle-free Technologiesmentioning

confidence: 99%

Technologies to Improve Immunization

Papania¹,

Zehrung²,

Jarrahian³

2018

Plotkin's Vaccines

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“…A key step in implementing a new vaccine is optimisation of the dosing quantity (hereafter 'dose') [4]. As the dose per individual is increased, the cost per individual vaccinated and vaccine toxicity may also increase [5]. We might also assume that the protective efficacy of a vaccine may vary with dose.…”

Section: Introductionmentioning

confidence: 99%

Response Type and Host Species may be Sufficient to Predict Dose-Response Curve Shape for Adenoviral Vector Vaccines

et al. 2020

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Vaccine dose-response curves can follow both saturating and peaking shapes. Dose-response curves for adenoviral vector vaccines have not been systematically described. In this paper, we explore the dose-response shape of published adenoviral animal and human studies. Where data were informative, dose-response was approximately five times more likely to be peaking than saturating. There was evidence that host species and response type may be sufficient for prediction of dose-response curve shape. Dose-response curve shape prediction could decrease clinical trial costs, accelerating the development of life-saving vaccines.

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Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial

Cited by 42 publications

References 23 publications

Conjugation of a peptide autoantigen to gold nanoparticles for intradermally administered antigen specific immunotherapy

Conjugation of a peptide autoantigen to gold nanoparticles for intradermally administered antigen specific immunotherapy

Technologies to Improve Immunization

Response Type and Host Species may be Sufficient to Predict Dose-Response Curve Shape for Adenoviral Vector Vaccines

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