Abstract
Objective
To evaluate the safety and immunogenicity of the inactivated SARS-CoV-2 vaccine in cancer patients.
Material and method
364 cancer patients who received two doses of vaccine were enrolled. The presence of SARS-CoV-2 anti-Spike protein IgG and neutralizing antibody 2 months following vaccination were measured by ELIZA.
Results
Injection site pain and fever were the most common local and systemic side effects. The overall seroconversion rate was 86.9% that was lower in older age, those with hematological malignancies and chemotherapy receivers.
Conclusion
The result of study confirmed the safety and short-term efficacy of inactivated vaccine in patients with malignancies.
Acknowledgments
The authors thank all patients who participate in the project. Also, a special thanks to Ms Batol Keykhosravi, Ms Azam Akbari Yazdi for their great helps and staff of Clinical Research Development Unit, Hospital Research Development Committee, Sabzevar University of Medical Sciences and Cancer Research Center, Shahid Beheshti University of Medical Sciences for their supports. Moreover, authors truly appreciate all efforts have been done by Dr Gary H. Lyman for data analyzing and critical review of the article.
Ethical approval statement
The protocol of the study was approved by the Ethics Committee of Sabzevar University of Medical Sciences (IR.MEDSAB.REC.1400.027) and a written informed consent form was obtained from the patients or the legal guardian.
Author contributions
Study concept and design: S. A. J.; acquisition of data: M. A., P. P., B. P., D. F., M. D., M. N.; analysis and interpretation of data: S. A. J. and G. H. L.; drafting of the manuscript: F. H.; critical revision of the manuscript for important intellectual content: M. F., J. S. W., S. A. J.; statistical analysis: G. H. L.
Disclosure statement
The authors report no conflicts of interest.
Preprint submission
The paper is posted as a preprint on medRxiv database and its DOI is https://doi.org/10.1101/2021.09.02.21262760 and it is available from https://www.medrxiv.org/content/10.1101/2021.09.02.21262760v2.
Data availability statement
All data generated and analyzed during this study can be accessed through direct communication with the corresponding author and the agreement of all research team members.