Safety and immunogenicity of CoronaVac in healthy adults: A prospective observational multicenter real-world study in Henan Province, China

ABSTRACT

Vaccination has emerged as the primar approach for managing the COVID-19 pandemic. Despite certain clinical trials reporting the safety and immunogenicity of CoronaVac, additional multicenter real-world studies are still necessary. In this study, we recruited 506 healthy volunteers who were not infected with COVID-19 or vaccinated. Each participant provided peripheral blood samples three times: prior to the first dose of vaccine, prior to the second dose, and 8 weeks following the second dose. Ultimately, 388 participants completed the entire follow-up process. No serious adverse events were observed among any of the participants. Within 1 week of vaccination, 13.4% of participants experienced systemic adverse reactions, with fatigue (5.93%) and dizziness (3.35%) being the most frequent. Although some clinical indicators, including creatinine, significantly changed after vaccination (p < 0.05), the mean of all altered indicators remained within the normal range. The positive rates of neutralizing antibodies (NAb), IgG, and IgM were 12.3%, 18.85%, and 5.24% prior to the second dose, respectively; and 57.99%, 86.34%, and 2.32% at 8 weeks following the second dose, respectively. Additionally, seven indicators, such as sex, age, and BMI, were significantly correlated with NAb (p < 0.05). Finally, a prediction model was developed based on age, monocytes, and alanine aminotransferase (ALT) with an AUC value of 87.56% in the train set and 80.71% in the test set. This study demonstrated that safety and immunogenicity of CoronaVac were good. The prediction model based on the baseline clinical characteristics prior to vaccination can help to develop more suitable vaccination strategies.

KEYWORDS:

• CoronaVac
• neutralizing antibodies
• safety
• immunogenicity
• prediction model

Acknowledgements

We thank all the generous volunteer subjects who enrolled in the study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethics statement

Ethical clearance was obtained from the Ethics Committee of the First Affiliated Hospital of Zhengzhou University with Ethical Clearance Certificate 2021-KY-0580-002. Each participant signed informed consent.

Data availability statement

The original data presented in the study are included in the article/Supplementary Material. Further inquiries can be directed to the corresponding author.

Author contributions

ZGR and ZJY designed the study. BCR, LW, JYS, SSL, HYW, XMW, LL and GYC collected clinical samples. LW and CYY performed the test of routine blood examination, liver and kidney function and anti-SARS-CoV-2 antibodies. ZGR, BCR and MZY analysed the data. BCR and MZY wrote the manuscript. All authors read and approved the final manuscript.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/21505594.2024.2310450

Additional information

Funding

This study was sponsored by grants from the National Key Research and Development Program of China (2022YFC2303100 and 2023YFC3043514), Henan Province Epidemic Prevention and Control Emergency Scientific Research Project (221111311700 and 221111311600), Central Plains Talents Program Central Plains Youth Top Talent Funding (Henan Talent Office [2021] No. 1), Young and middle-aged academic leaders of Henan Provincial Health Commission (HNSWJW-2022013), Funding for Scientific Research and Innovation Team of The First Affiliated Hospital of Zhengzhou University (QNCXTD2023002), The Research Project of Jinan Microecological Biomedicine Shandong Laboratory (JNL-2022015B and JNL-2022001A), and State Key Laboratory of Antiviral Drugs, Independent and Innovation Project for Graduate Students of Academy of Medical Science of Zhengzhou University.