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Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects.

ABSTRACT: The objectives of this study were to assess the acceptability and usability of a newly developed intradermal prototype device, VAX-ID™, in healthy subjects. In April 2012 an investigational study was conducted in healthy subjects aged 18 to 65 y. To compare injection site and route of administration, subjects were allocated to 4 subgroups, either receiving subsequently 2 intradermal (ID) injections (one in the forearm and one in the deltoid) or an ID (forearm) and an intramuscular (IM) (deltoid) injection. All injections contained saline solution. Acceptability was assessed with a subjects' questionnaire and a daily electronic diary for 5 d. Usability was assessed with a vaccinators' questionnaire and an expert panel. A 10-point Visual Analog Scale was used to score several statements on usability and acceptability. A total of 102 healthy subjects were enrolled in the study (age: 19-63). No statistically significant differences were seen in demographic characteristics between the ID and IM groups. Anxiety before injection, pain during injection and duration of injection were rated significantly lower for ID compared to IM. One day after the injections, redness was reported more often after ID injection in the forearm versus ID in the deltoid; pain at injection site was reported significantly more often after IM vs. ID injection. The new VAX-ID prototype device was found easy to handle, easy to use and safe. The new VAX-ID prototype device was shown to have a high degree of acceptability as well as usability. Further studies with VAX-ID will be conducted using vaccine antigen allowing assessment of immunogenicity and safety. Additionally, these studies will help to further improve VAX-ID in terms of accuracy of delivered dose and feedback to the vaccinator. (NCT01963338).

SUBMITTER: Van Mulder TJ

PROVIDER: S-EPMC4514056 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects.

Van Mulder Timothi J S TJ Verwulgen Stijn S Beyers Koen C L KC Scheelen Linda L Elseviers Monique M MM Van Damme Pierre P Vankerckhoven Vanessa V

Human vaccines & immunotherapeutics 20140101 12

The objectives of this study were to assess the acceptability and usability of a newly developed intradermal prototype device, VAX-ID™, in healthy subjects. In April 2012 an investigational study was conducted in healthy subjects aged 18 to 65 y. To compare injection site and route of administration, subjects were allocated to 4 subgroups, either receiving subsequently 2 intradermal (ID) injections (one in the forearm and one in the deltoid) or an ID (forearm) and an intramuscular (IM) (deltoid) ...[more]

PMID: 25531808

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Project description:BackgroundUnderstanding the impact of socio-economic inequality on health outcomes is arguably more relevant than ever before given the global repercussions of Covid-19. With limited resources, innovative methods to track disease, population needs, and current health and social service provision are essential. To best make use of currently available data, there is an increasing reliance on technology. One approach of interest is the implementation and integration of mapping software. This research aimed to determine the usability and acceptability of a methodology for mapping public health data using GIS technology.MethodsPrototype multi-layered interactive maps were created demonstrating relationships between socio-economic and health data (vaccination and admission rates). A semi-structured interview schedule was developed, including a validated tool known as the System Usability Scale (SUS), which assessed the usability of the mapping model with five stakeholder (SH) groups. Fifteen interviews were conducted across the 5 SH and analysed using content analysis. A Kruskal-Wallis H test was performed to determine any statistically significant difference for the SUS scores across SH. The acceptability of the model was not affected by the individual use of smart technology among SHs.ResultsThe mean score from the SUS for the prototype mapping models was 83.17 out of 100, indicating good usability. There was no statistically significant difference in the usability of the maps among SH (p = 0.094). Three major themes emerged with respective sub-themes from the interviews including: (1) Barriers to current use of data (2) Design strengths and improvements (3) Multiple benefits and usability of the mapping model.ConclusionIrrespective of variations in demographics or use of smart technology amongst interviewees, there was no significant difference in the usability of the model across the stakeholder groups. The average SUS score for a new system is 68. A score of 83.17 was calculated, indicative of a "good" system, as falling within the top 10% of scores. This study has provided a potential digital model for mapping public health data. Furthermore, it demonstrated the need for such a digital solution, as well as its usability and future utilisation avenues among SH.

Dataset Information

Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects.

Publications

Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects.

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