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SARS-CoV-2 Delta Inactivated Vaccine: Safety Assessment in Sprague Dawley Rats and Cynomolgus Monkeys Jianhua Li, Haiyan Mao, Li Jiale, Yi Sun, Jiaxuan Li, Minglei Chu, Bin Wang, Meng Chen, Cheng Luo, Ju Li, Yanjun Zhang, Jinan Wu, Keda Chen d j) o0 ?. H $ c: P+ b% G G! L Abstract ; s7 B6 ]& ]3 H# l% Q& ^: d Developing a reliable and safe SARS-CoV-2 vaccine is essential to halt the COVID-19 pandemic. Preclinical studies are designed to evaluate vaccine safety. Testing vaccine toxicity in animals helps predict safety in humans, thereby reducing risks during human use and providing a foundation for clinical trial design. This study aimed to (1) provide a reference for clinical research by assessing the toxicity of a SARS-CoV-2 inactivated vaccine (Vero cell line, Delta strain B.1.617.2) following six weeks of repeated intramuscular injections, and (2) evaluate the acute toxicity of the vaccine in Sprague-Dawley rats over 14 days after a single intramuscular injection. Repeated intramuscular injections in cynomolgus monkeys revealed elevated body temperature, eosinophils, fibrillation, and cytokine IL-6 levels after the first and/or last injection, with no evident systemic damage; five doses per monkey were deemed safe. Injection site irritation was observed at one and five doses per monkey, with recovery noted after four weeks. High levels of specific IgG antibodies against the S1 protein were detected in all animals. These findings suggest the vaccine is safe and support progression to human phase I clinical trials. Additionally, this study provides a protocol for developing a preclinical evaluation system for next-generation SARS-CoV-2 vaccines. `( O1 ?$ X# ] Keywords. G( A% a( |. V0 |% e SARS-CoV-2; Inactivated Vaccine; Delta Variant; Safety Assessment; Sprague Dawley Rat; Cynomolgus Monkey; Single Dose, Toxicity Full Text:8 ?. Z$ s% R$ \# a 9 r5 F5 ], h% V1 _3 ` DOI: https://doi.org/10.21092/jav.v14i4.124 |
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Development and Application of a Time-Resolved Fluorescence Immunoassay for Quantification of Rabies Virus Glycoprotein Antigen5 p3 q) {* w1 u+ u! } L { Chunhui He, Haolin Fang, Jieping Liu, Linqing Xie, Yebo Li, Ting Zhou, Wentang Li, Xiujuan Zhuang, Weiyan Xie, Xingling Lyu, Zihang Xu, Hongying Chen# {+ _! `6 R' x# e- a) K Abstract: p8 H6 X* J) ]6 ~( |3 v " ]/ }1 y4 Z6 q- E8 K, D Objective: To establish and validate a time-resolved fluorescence immunoassay (TRFIA) for quantifying rabies virus glycoprotein antigen, thereby enhancing the quality control capabilities of rabies vaccines. Methods: A novel detection method was developed using a TRFIA-based kit. The kit's performance was comprehensively evaluated through method validation and comparative analysis against results obtained from an enzyme-linked immunosorbent assay (ELISA) kit. Results: The TRFIA method met all predetermined validation criteria. Assay results demonstrated a strong correlation with ELISA outcomes, while providing a broader quantitative range, greater resistance to interference, and superior methodological robustness. Conclusion: The TRFIA-based method for rabies virus glycoprotein quantification delivers reliable quality control results when applied to in-process samples and final rabies vaccine products..5 U6 n9 K4 Y5 L& N+ [ " s; @6 n/ _; V+ \( y6 G3 b) M$ j# @ 8 ^) Z+ r5 N5 Y5 }- f Keywords ! P. g5 \6 a8 H0 p Time-Resolved Fluorescence Immunoassay; Rabies Virus; Glycoprotein; Vaccine; Quality Control* d8 V9 C7 U6 n9 O# b: @5 n Full Text: PDF- W% G! k8 K1 B o: d6 C DOI: https://doi.org/10.21092/jav.v14i4.125 |
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Potential Mechanisms of Baicalin against Viral Pneumonia Revealed by Network Pharmacology and Molecular Docking `1 [. ^! g9 W: s. O: U; Q He Li, Ruiqiu Zhang & H$ t9 H1 \7 I5 l/ S Abstract 0 Z1 M; m3 |1 m: _& O While baicalin exhibits therapeutic potential against viral pneumonia, its systems-level mechanisms remain elusive. This study integrates network pharmacology, transcriptomic profiling, and molecular docking to decode these multi-target interactions. By mapping baicalin-associated genes against viral pneumonia profiles, we identified 223 shared targets. Subsequent network topology analysis prioritized core hub genes (e.g., AKT1, IL6, TP53, CTNNB1, and BCL2), whose clinical relevance was corroborated using a severe COVID-19 transcriptomic dataset (GSE171110). Specifically, the expression data revealed significant dysregulation in key inflammatory and apoptotic mediators, including the marked upregulation of MMP9, STAT3, and CASP3. Functional enrichment linked these networks primarily to PI3K-Akt signaling, MAPK cascades, and host antiviral immune responses. Furthermore, molecular docking confirmed high-affinity binding (–7.5 to –9.0 kcal/mol) between baicalin and the top five hub proteins. These findings delineate the specific kinase and cytokine networks mediating baicalin’s protective effects, providing an empirically supported framework for future experimental validation.+ V' P6 W$ }; s7 f4 I9 a " G6 C4 X: O' s6 ^) y ( A* m- L) Z% o& L/ P9 Z Keywords n) y# F$ o; K6 n3 G- y Baicalin; Viral pneumonia; Network pharmacology; Molecular docking; Inflammatory response; COVID-19" ]5 K* W' y* R+ c* p5 I& A7 S3 |4 c Full Text:& D% y9 z; E# i- |4 H3 z, f6 K PDF+ H" |, h+ ]$ ]$ y0 I ! J2 l0 Z( w# A! w: D0 X + L l" W1 S5 I9 \6 I DOI: https://doi.org/10.21092/jav.v14i4.126 |
