The safety and immunogenicity of inactivated rotavirus vaccine delivered by a dissolving microneedle patch in rats.

ABSTRACT: The development of dissolving microneedle patches (dMNPs) for inactivated rotavirus vaccine (IRV) requires concurrent evaluation of safety parameters, including local and systemic toxicity and immune response characteristics. The aim of this study is to evaluate the toxicological safety profiles and immunogenic potential of IRV dMNPs in rats through assessment of systemic toxicity, local responses, and neutralizing activities. IRV dMNPs were examined for stability under different storage conditions (5 ± 3°C and 25 ± 2°C) for up to 24 months. Toxicology assessment included clinical observation, body weight monitoring, food consumption, hematology, clinical chemistry, organ weight analysis, and histopathological examination. Local tolerance was evaluated using Draize scoring and microscopic

SUBMITTER: Moon SS 

PROVIDER: S-EPMC12439544 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature