Related Experiment Video
Updated: Jan 18, 2026
In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
Published on: May 11, 2020
The safety and immunogenicity of inactivated rotavirus vaccine delivered by a dissolving microneedle patch in rats
Sung-Sil Moon1, Marly Richter-Roche2, Yuhuan Wang1
1Division of Viral Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
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 examination of the administration sites. Immunogenicity was evaluated by measuring neutralizing activities in sera against homotypic and heterotypic RV strains. The potency of IRV dMNPs was found stable for at least 24 months at 5 ± 3°C, and for 12 months at 25 ± 2°C. Toxicological evaluation showed no adverse systemic effects, with all clinical pathology parameters remaining within normal ranges. Local dermal reactions were mild (mean Draize scores <1.5) and subsided within 48 h. Histopathology showed only low to mild inflammatory changes at the application sites, with complete resolution by the end of study (day 57). Immunological analysis showed robust and cross-reactive neutralizing activities against homotypic and heterotypic RV strains in sera of rats. IRV dMNPs showed strong stability and an excellent safety profile while also inducing robust and extensive immune responses, supporting its further development as an alternate IRV platform.
Insights
Dissolving microneedle patches (dMNPs) for inactivated rotavirus vaccine (IRV) are stable for up to 24 months and show an excellent safety profile. These dMNPs induce robust immune responses, supporting their development as an alternative vaccine platform.
Area of Science:
- Vaccinology
- Biomaterials Science
- Toxicology
Background:
- The development of novel vaccine delivery systems is crucial for improving vaccine efficacy and patient compliance.
- Dissolving microneedle patches (dMNPs) offer a promising alternative to traditional vaccine administration methods.
- Inactivated rotavirus vaccine (IRV) is essential for preventing rotavirus gastroenteritis, a leading cause of infant mortality worldwide.
Purpose of the Study:
- To evaluate the toxicological safety and immunogenic potential of inactivated rotavirus vaccine delivered via dissolving microneedle patches (IRV dMNPs) in a rat model.
- To assess the stability of IRV dMNPs under various storage conditions.
- To determine the local and systemic toxicity, as well as the immune response elicited by IRV dMNPs.
Main Methods:
- IRV dMNPs were subjected to stability testing at 5°C and 25°C for up to 24 months.
- Toxicological safety was assessed through clinical observations, body weight monitoring, food consumption, hematology, clinical chemistry, organ weight analysis, and histopathology.
- Local tolerance was evaluated using Draize scoring and microscopic examination of administration sites.
- Immunogenicity was determined by measuring neutralizing antibody titers against rotavirus strains in rat sera.
Main Results:
- IRV dMNPs demonstrated stability for at least 24 months at 5°C and 12 months at 25°C.
- No adverse systemic effects were observed; all clinical pathology parameters remained within normal ranges.
- Local dermal reactions were mild and transient, with histopathology showing minimal inflammation that resolved completely.
- IRV dMNPs induced robust, cross-reactive neutralizing antibody responses against homotypic and heterotypic rotavirus strains.
Conclusions:
- IRV dMNPs exhibit excellent stability and a favorable safety profile, with minimal local and no systemic toxicity.
- The dMNP platform effectively elicits strong and broad immune responses against rotavirus.
- IRV dMNPs represent a viable and promising alternative platform for inactivated rotavirus vaccination.
