Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects
Faculty of Medicine and Health Sciences
Faculty of Design Sciences
Human vaccines & immunotherapeutics
, p. 3746-3753
University of Antwerp
Background The objectives of this study was to assess the acceptability and usability of a newly developed intradermal prototype device, VAX-ID, in healthy subjects. Materials & Methods In April 2012 an investigational study was conducted in healthy subjects aged 18 to 65 years. To compare injection site and route of administration, subjects were allocated to four subgroups, either receiving subsequently two intradermal (ID) injections (one in the forearm & 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 days. Usability was assessed with a vaccinators questionnaire and an expert panel. A 10-point Visual Analogue Scale was used to score several statements on usability and acceptability. Results 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 versus ID injection. The new VAX-ID prototype device was found easy to handle, easy to use and safe. Conclusion 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).