T J S Van Mulder1, D Van Nuffel2, M Demolder3, G De Meyer3, S Moens4, K C L Beyers5, V V J Vankerckhoven6, P Van Damme7, H Theeten7. 1. Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium. Electronic address: timothi.vanmulder@uantwerpen.be. 2. Department of Biomedical Sciences, 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. 5. Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Voxdale, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium. 6. Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium. 7. Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium.
Abstract
BACKGROUND: In the context of precision medicine and in response to the highly needed capacity of rapid interventions towards new infectious diseases and pandemic outbreaks, intradermal immunization is gaining increased attention. However, the currently used Mantoux technique for ID injection is difficult to standardize and requires training, especially when used in children. To allow determining the maximum penetration depth and needle characteristics for the development of a platform of medical devices suited for intradermal injection, VAX-ID® and to ensure an accurate ID injection in children, the epidermal and dermal thickness at the proximal ventral and dorsal forearm (PVF & PDF) and at the deltoid region in children aged 8 weeks to 18 years were assessed. The lateral part of the upper leg was assessed as well in children aged 8 weeks to 2 years since it is a commonly used injection site in this population. MATERIALS & METHODS: Mean thickness of the PVF, PDF, lateral part of the upper leg and deltoid were measured using high-frequency ultrasound. Association with gender, age and BMI was assessed using Mann-Whitney U Test, Spearman correlation and Wilcoxon Signed Ranks Test, respectively. RESULTS: Results showed an overall mean skin thickness of 0.99 mm (SD: 0.14 mm) at the PVF, 1.20 mm (SD: 0.17) at the PDF, 1.28 mm (SD: 0.16) at the lateral part of the upper leg and increasing to 1.32 mm (0.25) at the deltoid region. Age and BMI correlated significantly (p < 0.001) with skin thickness at all investigated body sites. Gender did not affect skin thickness in the investigated population. CONCLUSION: Significant differences in skin thickness at the PVF, PDF and deltoid region were seen according to age and BMI. An optimal needle length of 0.7 mm is advised to guarantee intradermal injection in children at all investigated injection sites. (NCT02727114).
BACKGROUND: In the context of precision medicine and in response to the highly needed capacity of rapid interventions towards new infectious diseases and pandemic outbreaks, intradermal immunization is gaining increased attention. However, the currently used Mantoux technique for ID injection is difficult to standardize and requires training, especially when used in children. To allow determining the maximum penetration depth and needle characteristics for the development of a platform of medical devices suited for intradermal injection, VAX-ID® and to ensure an accurate ID injection in children, the epidermal and dermal thickness at the proximal ventral and dorsal forearm (PVF & PDF) and at the deltoid region in children aged 8 weeks to 18 years were assessed. The lateral part of the upper leg was assessed as well in children aged 8 weeks to 2 years since it is a commonly used injection site in this population. MATERIALS & METHODS: Mean thickness of the PVF, PDF, lateral part of the upper leg and deltoid were measured using high-frequency ultrasound. Association with gender, age and BMI was assessed using Mann-Whitney U Test, Spearman correlation and Wilcoxon Signed Ranks Test, respectively. RESULTS: Results showed an overall mean skin thickness of 0.99 mm (SD: 0.14 mm) at the PVF, 1.20 mm (SD: 0.17) at the PDF, 1.28 mm (SD: 0.16) at the lateral part of the upper leg and increasing to 1.32 mm (0.25) at the deltoid region. Age and BMI correlated significantly (p < 0.001) with skin thickness at all investigated body sites. Gender did not affect skin thickness in the investigated population. CONCLUSION: Significant differences in skin thickness at the PVF, PDF and deltoid region were seen according to age and BMI. An optimal needle length of 0.7 mm is advised to guarantee intradermal injection in children at all investigated injection sites. (NCT02727114).