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Influenza A Virus Studies in a Mouse Model of Infection
Published on: September 7, 2017
Preclinical safety evaluation of a bivalent inactivated EV71-CA16 vaccine in mice immunized intradermally
Yun Liao1, Qinfang Jiang1, Xinqian Huo1
1Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, China.
Abstract:
Hand, foot and mouth disease is a common acute viral infectious disease that poses a serious threat to the life and health of young children. With the development of an effective inactivated EV71 vaccine, CA16 has become the main pathogen causing HFMD. Effective and safe vaccines against this disease are urgently needed. In our previous study, a bivalent inactivated vaccine was shown to have good immunogenicity and to induce neutralizing antibodies in mice and monkeys. Repeated administration toxicity is a critical safety test in the preclinical evaluation of vaccines. In this study, BALB/c mice were used to evaluate the toxicity of the bivalent vaccine after multiple intradermal administrations. Clinical observation was performed daily, and body weight, food intake, hematological characteristics, serum biochemical parameters, antinuclear antibodies, CD4+/CD8a+ T-cell proportions, bone marrow smear results and pathology results were recorded. The results showed that there was no significant change at the injection site and no adverse reactions related to the vaccine. The bivalent inactivated EV71-CA16 vaccine exhibits good safety in mice, and these results provide a sufficient basis for further clinical trials.
Insights
A new bivalent inactivated vaccine for Hand, Foot, and Mouth Disease (HFMD) shows excellent safety in mice. This vaccine, targeting EV71 and CA16, demonstrated no adverse reactions after repeated administration, supporting further clinical trials.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Toxicology
Background:
- Hand, Foot, and Mouth Disease (HFMD) is a significant childhood illness.
- Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) are primary HFMD pathogens.
- An effective bivalent inactivated vaccine against EV71 and CA16 is needed.
Purpose of the Study:
- To assess the safety of a bivalent inactivated EV71-CA16 vaccine.
- To evaluate potential toxicity following repeated intradermal administration in a preclinical mouse model.
Main Methods:
- BALB/c mice received multiple intradermal doses of the bivalent vaccine.
- Daily clinical observations were conducted.
- Parameters assessed included body weight, food intake, hematology, serum biochemistry, antinuclear antibodies, T-cell subsets (CD4+/CD8+), bone marrow smears, and histopathology.
Main Results:
- No significant local reactions were observed at the vaccine injection sites.
- No vaccine-related adverse events were detected throughout the study period.
- Hematological, biochemical, immunological, and pathological assessments revealed no significant safety concerns.
Conclusions:
- The bivalent inactivated EV71-CA16 vaccine demonstrates a favorable safety profile in mice.
- These preclinical findings support the progression of this vaccine candidate into human clinical trials.
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