Injectability, Suitability, and Dose Accuracy of VAX-ID® (IDE-2200); Its Clinical Evaluation; Covering an Exploratory Review on its Potential Applications as an Intradermal Injection Device for Drug Delivery

Abstract

Introduction
Intradermal (ID) injection has gained renewed interest due to its dose-sparing potential. This route of administration targets the dermal layer of the skin and can save the injected substance dose, decrease volumes kept in the cold chain, and increase acceptability. ID vaccination is particularly attractive for use in mass vaccination campaigns, or for vaccines that are expensive or in short supply. Hence VAX-ID® (IDE-2200) would contribute to lessening the impact of the current pandemic of SARS Covid-19 or emerging epidemics. The main aim of this thesis was to evaluate the injectability, suitability, and dose accuracy of VAX-ID® (IDE-2200), an ID injection device produced by Idevax BV.
Methods
Two 12kg piglets received 25 injections using VAX-ID® (IDE-2200) containing 32G and 27G needles. An injection mixture of NaCl 0.9% and Chinese ink 1:0.15 ratio was injected in 3 sites: the neck, back, and abdomen. The injection sites were immediately visually inspected for bleb formation, leakage, and local adverse effects. The piglets were then euthanized, and tissue samples were collected and immediately fixed in 4% buffered formalin. The samples were stained with hematoxylin and eosin (H&E) for histological analysis. Jointly, a technical test was run to determine the dose accuracy by measuring the dead volume of VAX-ID® (IDE-2200) compared to Mantoux, where 180 VAX-ID® (IDE-2200) with 32G and 27G needles along with 62 syringe-needle (29G) model used in Mantoux have been measured as empty, filled, and after ejection.
Results
Visual inspection showed bleb formation in 95.24% of the samples evaluated, and the average bleb diameter was 0.61cm. ID injection using VAX-ID® (IDE-2200) showed dye deposition mainly in the dermis reaching both the papillary and reticular dermis. Transient erythema was observed in the injection site, micro bleeding was only noticed in two samples, and macro bleeding was not observed in any of the samples. Simultaneously, dose accuracy of VAX-ID® (IDE-2200) was found to be 6 μl.
Conclusion
VAX-ID® (IDE-2200) was able to successfully inject the dye in the dermal layer of the skin in 12kg piglets, as confirmed by the histological evaluation. The device induced bleb formation after injection, indicating a successful ID injection. No serious adverse events were observed. Dose accuracy of VAX-ID® (IDE-2200) is therefore concluded to be non-inferior to the Mantoux technique.

Date of Award	16 Sept 2022
Original language	English
Awarding Institution	University of Namur
Supervisor	Yves Geysels (Supervisor)