High frequency ultrasound to assess skin thickness in healthy adults |
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| Institution: | 1. Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium;2. Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium;3. Department of Pharmaceutical Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium;4. Voxdale, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium;1. Department of Dermatology, University Hospital Zürich, Gloriastr 31, 8091 Zürich, Switzerland;2. Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 275 York Avenue, New York, NY 10065, USA;1. Project for Vaccine and Immune Regulation, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka 565-0871, Japan;2. Laboratory of Biotechnology and Therapeutics, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka 565-0871, Japan;3. Department of Dermatology, Nara Medical University, 840 Shin-cho, Kashihara, Nara 634-8522, Japan;4. Department of Dermatology,Course of Integrated Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan;5. CosMED Pharmaceutical Co. Ltd., 32 Higashikujokawanishi-cho, Minami-ku, Kyoto 601-8014, Japan;6. Laboratory of Vaccine and Immune Regulation, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka 565-0871, Japan;1. Department of Skin and Venereal Diseases, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania;2. Ultrasound Institute, Kaunas University of Technology, Kaunas, Lithuania;1. University of Salzburg, Department of Molecular Biology, Hellbrunnerstr. 34, Salzburg, Austria;2. Pantec Biosolutions AG, Industriering 21, Ruggell, Liechtenstein |
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| Abstract: | BackgroundIntradermal immunization is gaining increased attention due to multiple factors: (1) intradermal (ID) vaccination has been shown to induce improved immunogenicity compared to intramuscular (IM) vaccination; (2) ID vaccination has been shown to have a dose-sparing potential over IM leading to a reduced vaccine cost and an increased availability of vaccines worldwide. However, the currently used Mantoux technique for ID injection is difficult to standardize and requires training.The aim of the study was (1) to assess the epidermal and dermal thickness at the proximal ventral and dorsal forearm (PVF & PDF) and deltoid in adults aged 18–65 years (2) to determine the maximum penetration depth and needle characteristics for the development of a platform of medical devices suited for intradermal injection, VAX-ID?.Materials and methodsMean thickness of the PVF, PDF and deltoid were measured using high-frequency ultrasound of healthy adults aged 18–65 years. Correlation with gender, age and BMI was assessed using Mann-Whitney U Test, Spearman correlation and Wilcoxon Signed Ranks Test, respectively.ResultsResults showed an overall mean skin thickness of 1.19 mm (0.65–1.55 mm) at the PVF, 1.44 mm (0.78–1.84 mm) at the PDF, and 2.12 mm (1,16–3.19 mm) at the deltoid. Thickness of PVF & PDF and deltoid were significantly different for men vs women (pmean < 0.001, <0.001, <0.001, and pmin < 0.001, 0.012, <0.001, respectively). A significant association was found for age at the deltoid region (p < 0.001). Skin thickness for PVF, PDF & deltoid was significantly associated to BMI (p < 0.001).ConclusionSignificant differences in skin thickness were seen for the PVF, PDF and deltoid region for gender, and BMI. Age only influenced the skin thickness at deltoid region. A needle length of 1.0 mm is best option for intradermal injection at the dorsal forearm (NCT02363465). |
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| Keywords: | Skin thickness Intradermal Injection device Vaccine delivery |
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