Repeated-dose toxicity and immunogenicity evaluation of norovirus P particle-based rotavirus vaccine in juvenile cynomolgus monkeys - Summary - MDSpire

Repeated-dose toxicity and immunogenicity evaluation of norovirus P particle-based rotavirus vaccine in juvenile cynomolgus monkeys

  • By

  • Wei Pan

  • Yingjie Cheng

  • Xiaojing Shi

  • Yunxiang Chen

  • Cong Xu

  • Zhengbiao Yang

  • Qijiong Lu

  • Lei Wen

  • Fang Liu

  • Tingli Bian

  • Li Qin

  • Shuizhen Pan

  • Ying Chen

  • Changwei Wu

  • Lijiang Zhang

  • Hongzhong Yang

  • June 9, 2026

  • 0 min

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Objective:

To evaluate the repeated-dose toxicity and immunogenicity of a bivalent rotavirus subunit candidate vaccine PP-P[6]/P[8]-VP8 Mix (containing equal amounts of P[6]-VP8 and P[8]-VP8 chimeric antigens) in cynomolgus monkeys.

Key Findings:
  • No toxicologically significant abnormalities were observed during the study, indicating a favorable safety profile for the vaccine.
  • Histopathological examination revealed mild subacute inflammatory reactions at the injection site and lymphoid follicle hyperplasia in draining lymph nodes.
  • These findings are typical local immune response manifestations associated with aluminum adjuvant vaccines.
Interpretation:

The study demonstrates the safety and immunogenicity of the PP-P[6]/P[8]-VP8 Mix vaccine under experimental conditions.

Limitations:
  • The study was conducted in a controlled environment with a limited sample size (5 monkeys per group).
  • Long-term effects and efficacy in humans remain to be evaluated.
Conclusion:

The findings support the entry of the PP-P[6]/P[8]-VP8 Mix vaccine into clinical research.

Original Source(s)

Repeated-dose toxicity and immunogenicity evaluation of norovirus P particle-based rotavirus vaccine in juvenile cynomolgus monkeys

  • by Wei Pan, Yingjie Cheng, Xiaojing Shi, Yunxiang Chen, Cong Xu, Zhengbiao Yang, Qijiong Lu, Lei Wen, Fang Liu, Tingli Bian, Li Qin, Shuizhen Pan, Ying Chen, Changwei Wu, Lijiang Zhang, Hongzhong Yang

  • June 9, 2026

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