Advanced search
Publication Cover
Human Vaccines & Immunotherapeutics Volume 18, 2022 - Issue 4: ISV Annual Congress
Submit an article Journal homepage
7,211
Views
4
CrossRef citations to date
0
Altmetric
ISV Annual Congress SF – Research Paper

Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings

Cristyn Daviesa Specialty of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia;b Sydney Institute of Infectious Diseases, University of Sydney, Sydney, AustraliaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-1506-3285View further author information
ORCID Icon,
Melody Tabaa Specialty of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia;b Sydney Institute of Infectious Diseases, University of Sydney, Sydney, AustraliaORCID Iconhttps://orcid.org/0000-0002-2954-1092View further author information
ORCID Icon,
Lucy Denga Specialty of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia;c National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Westmead, AustraliaORCID Iconhttps://orcid.org/0000-0003-0066-2218View further author information
ORCID Icon,
Ceylan Karatasa Specialty of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia;d Graduate School of Medicine, The University of Wollongong, Keiraville, AustraliaView further author information
,
Shopna Bage Centre for Population Health, Western Sydney Public Health Unit, North Parramatta, Australia;f Faculty of Medicine and Health, Westmead Clinical School, The University of Sydney, Westmead, AustraliaORCID Iconhttps://orcid.org/0000-0001-6987-3764View further author information
ORCID Icon,
Charles Rossg Vaxxas Pty Ltd, Translational Research Institute, Woolloongabba, AustraliaView further author information
,
Angus Forsterg Vaxxas Pty Ltd, Translational Research Institute, Woolloongabba, AustraliaView further author information
,
Robert Booya Specialty of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia;b Sydney Institute of Infectious Diseases, University of Sydney, Sydney, AustraliaORCID Iconhttps://orcid.org/0000-0002-1953-7452View further author information
ORCID Icon &
S. Rachel Skinnera Specialty of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia;b Sydney Institute of Infectious Diseases, University of Sydney, Sydney, AustraliaORCID Iconhttps://orcid.org/0000-0003-1970-9792View further author information
ORCID Icon show all
Article: 2018863 | Received 08 Oct 2021, Accepted 10 Dec 2021, Published online: 31 Jan 2022

References

  • Jeong SY, Park JH, Lee YS, Kim YS, Park JY, Kim SY. The current status of clinical research involving microneedles: a systematic review. Pharmaceutics. 2020;12:1–15. doi:10.3390/pharmaceutics12111113.
  • Forster AH, Witham K, Depelsenaire ACI, Veitch M, Wells JW, Wheatley A, Pryor M, Lickliter JD, Francis B, Rockman S, et al. Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: results from a randomized, controlled phase 1 clinical trial. PLoS Med. 2020;17. doi:10.1371/journal.pmed.1003024.
  • Hossain MK, Ahmed T, Bhusal P, Subedi RK, Salahshoori I, Soltani M, Hassanzadenganroudsari, M . Microneedle systems for vaccine delivery: the story so far. Expert Rev Vaccines. 19:1153–1166. 2021; doi:10.1080/14760584.2020.1874928.
  • Norman JJ, Arya JM, McClain MA, Frew PM, Meltzer MI, Prausnitz MR. Microneedle patches: usability and acceptability for self-vaccination against influenza. Vaccine. 2014;32:1856–62.
  • Guillermet E, Alfa DA, Phuong Mai LT, Subedi M, Demolis R, Giersing B, Jaillard P. End-user acceptability study of the nanopatchTM; a microarray patch (MAP) for child immunization in low and middle-income countries. Vaccine. 2019;37:4435–43. doi:10.1016/j.vaccine.2019.02.079.
  • Jacoby E, Jarrahian C, Hull HF, Zehrung D. Opportunities and challenges in delivering influenza vaccine by microneedle patch. Vaccine. 2015;33(37):4699–704. doi:10.1016/j.vaccine.2015.03.062.
  • Birchall JC, Clemo R, Anstey A, John DN. Microneedles in clinical practice–an exploratory study into the opinions of healthcare professionals and the public. Pharm Res. 2011;28:95–106. doi:10.1007/s11095-010-0101-2.
  • Fernando GJP, Hickling J, Flores J, Cesar M, Griffin P, Anderson CD, Davies C, Witham K, Pryor M, Bodle J. Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch™). Vaccine. 2018;36:3779–88. doi:10.1016/j.vaccine.2018.05.053.
  • Griffin P, Elliott S, Krauer K, Davies C, Rachel Skinner S, Anderson CD, Forster A. Safety, acceptability and tolerability of uncoated and excipient-coated high density silicon micro-projection array patches in human subjects. Vaccine. 2017;35:6676–84. doi:10.1016/j.vaccine.2017.10.021.
  • Frew PM, Paine MB, Rouphael N, Schamel J, Chung Y, Mulligan MJ, Prausnitz, MR . Acceptability of an inactivated influenza vaccine delivered by microneedle patch: results from a phase I clinical trial of safety, reactogenicity, and immunogenicity. Vaccine. 2020;38:7175–81. doi:10.1016/j.vaccine.2020.07.064.
  • Rouphael NG, Paine M, Mosley R, Henry S, McAllister DV, Kalluri H, Pewin W, Frew PM, Yu T, Thornburg NJ, et al. The safety, immunogenicity and acceptability of inactivated influenza vaccine delivered by microneedle patch: a randomized, partially blind, placebo-Controlled Phase 1 trial. Lancet. 2017;390:649–58. doi:10.1016/S0140-6736(17)30575-5.
  • Arya S, Henry S, Kalluri H, McAllister DV, Pewin WP, Prausnitz MR. Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects. Biomaterials. 2017;128:1–7. doi:10.1016/j.biomaterials.2017.02.040.
  • Eldridge S, Chan C, Campbell M, Bond C, Hopewell S, Thabane L, Lancaster GA. CONSORT statement: extension to randomised pilot and feasibility trials. Br Med J. 2016;355:i5239. doi:10.1136/bmj.i5239.
  • Eldridge S, Lancaster GA, Campbell M, Thabane L, Hopewell S, Coleman C, Bond CM. Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework. PloS One. 2016;11:e0150205. doi:10.1371/journal.pone.0150205.
  • Thabane L, Hopewell S, Lancaster GA, Bond C, Coleman C, Campbell M, Eldridge, SM . Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot and Feasability Studies. 2016;2:25.
  • Thabane L, Lancaster GA. A guide to the reporting of protocols of pilot and feasibility trials. Pilort Feasability Stud. 2019;5. doi:10.1186/s40814-019-0423-8.
  • Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot and Feasability Studies. 2019;5:17.
  • Lucie R, Gauvin L, Raine K. Ecological models revisited: their uses and evolution in health promotion over two decades. Annu Rev Public Health. 2011;32:307–26. doi:10.1146/annurev-publhealth-031210-101141.
  • Montano DE, Kasprzyk D. Theory of reasoned action, theory of planned behaviour, and the integrated behavioural model. In: Glanz K, Rimer BK, Viswanath K, editors. Health behavior: theory research and practice. New York, NY: Wiley; 2014. p. 95–124.
  • ISO-9241-11. Ergonomics of human-system interaction.
  • Cunningham MS, Davison C, Aronson KJ. HPV vaccine acceptability in Africa: a systematic review. Prev Med. 2014;69:274–79. doi:10.1016/j.ypmed.2014.08.035.
  • Ayala GX, Elder JP. Qualitative methods to ensure acceptability of behavioral and social interventions to the target population. J Public Health Dent. 2011;71(Suppl 1):S69–S79. doi:10.1111/j.1752-7325.2011.00241.x.
  • Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101. doi:10.1191/1478088706qp063oa.
  • TGA. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Therapeutics Goods Association: Commonwealth Department of Health and Aged Care. 2000.
  • WMA. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Helsinki (Finland): World Medical Association; 1964.
  • Dudley MZ, Halsey NA, Omer SB, Orenstein WA, O’Leary ST, Limaye RJ, Salmon, DA . The state of vaccine safety science: systematic reviews of the evidence. Lancet Infect Dis. 2020;20:e80–e9. doi:10.1016/S1473-3099(20)30130-4.
  • Dreskin SC, Halsey NA, Kelso JM, Wood RA, Hummell DS, Edwards KM, Caubet J-C, Engler RJM, Gold MS, Ponvert C. International Consensus (ICON): allergic reactions to vaccines. World Allergy Organ J. 2016;9. doi:10.1186/s40413-016-0120-5.
  • McMurty CM. Managing immunization stress-related response: a contributor to sustaining trust in vaccines. Can Commun Dis Rep. 2020;6:210–18. doi:10.14745/ccdr.v46i06a10.
  • WHO. Reducing pain at the time of vaccination: WHO position paper – September 2015. Weekly epidemiological record. Geneva (Switzerland): World Health Organization; 2015. p. 505–16.
  • Davies C, Marshall HS, Zimet G, McCaffery K, Brotherton JML, Kang M, Garland S, Kaldor J, McGeechan K, Skinner SR, for the HPV.edu Study Group. Effect of a school-based educational intervention about the human papillomavirus vaccine on psychosocial outcomes among adolescents: analysis of a cluster randomized trial. JAMA Network Open. 2021;4:e2129057. doi:10.1001/jamanetworkopen.2021.29057.
  • Davies C, Skinner SR, Stoney T, Marshall HS, Collins J, Jones J, Hutton H, Parrella A, Cooper S, McGeechan K, for the HPV.edu Study Group. ‘Is it like one of those infectious kind of things?’ The importance of educating young people about HPV and HPV vaccination at school. Sex Educ. 2017;17(3):256–75. doi:10.1080/14681811.2017.1300770.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.