Favorable safety and immunogenicity of a combined quadrivalent influenza and recombinant SARS-CoV-2 vaccine in Sprague-Dawley rats for both primary and booster immunization - Summary - MDSpire

Safety and Immunogenic Response of a Novel Combined Quadrivalent Influenza and Recombinant SARS-CoV-2 Vaccine in Sprague-Dawley Rats During Primary and Booster Doses

  • By

  • Jinjin Shao

  • Chengda Zhang

  • Guangbiao She

  • Tian Qin

  • Jinyao Zhang

  • Minxi Fang

  • Dan Zhao

  • Linying Wang

  • Lijuan Xia

  • Qian Yang

  • Lili Zhang

  • Yanling Zhang

  • Siming Zhang

  • Jiahong Wang

  • Zhiqi Xie

  • Yunxiang Chen

  • Ying Chen

  • Enqi Huang

  • Lijiang Zhang

  • July 17, 2026

Share

Objective:

To evaluate the safety and immunogenicity of a novel combined quadrivalent influenza and recombinant COVID-19 vaccine (Flu-CoV2) in Sprague-Dawley rats.

Approach:
  • Study Design: Three independent studies were conducted: primary immunization (Study 1) and booster immunization following prior influenza (Study 2) or COVID-19 (Study 3) vaccination.
  • Immunogenicity Assessment: Immunogenicity was determined using IgG antibody ELISA, plaque reduction neutralization tests for SARS-CoV-2, and hemagglutination inhibition assays for influenza viruses.
Key Findings:
  • No severe, life-threatening, or fatal adverse reactions occurred during any of the studies.
  • Transient injection-site nodules in adjuvanted groups resolved completely, and all transient post-vaccination shifts in hematologic and biochemical parameters normalized by the end of the recovery period.
  • The Flu-CoV2 vaccine effectively induced strong IgG and neutralizing antibody responses against both influenza and SARS-CoV-2.
  • Administered as a booster, it markedly augmented specific antibody levels in pre-immune models.
Interpretation:

These preclinical data demonstrate a favorable safety profile and potent immunogenicity for the Flu-CoV2 vaccine.

Limitations:
  • The study was conducted in Sprague-Dawley rats, which may limit the generalizability of the findings to humans.
  • Long-term safety and efficacy in humans have yet to be established.
Conclusion:

The findings support further development of the Flu-CoV2 vaccine.

Original Source(s)

Related Content