Animal models for cutaneous vaccine delivery.

Main challenges in skin vaccination are overcoming the stratum corneum (SC) barrier and targeting the antigen presenting cells (APC) in the epidermis and the dermis. For this purpose many delivery techniques are being developed. In vivo immunogenicity and safety studies in animals are mandatory before moving to clinical trials. However, the results obtained in animals may or may not be predictive for humans. Knowledge about differences and similarities in skin architecture and immunology within a species and between species is crucial. In this review, we discuss variables, including skin morphology, skin barrier function, mechanical properties, site of application and immunology, which should be taken into account when designing animal studies for vaccination via the skin in order to support the translation to clinical trial outcomes.