Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 6, 2022; 10(31): 11411-11418
Published online Nov 6, 2022. doi: 10.12998/wjcc.v10.i31.11411
Efficacy and safety profile of two-dose SARS-CoV-2 vaccines in cancer patients: An observational study in China
Sheng-Wei Cai, Jin-Yan Chen, Rong Wan, De-Jian Pan, Wei-Lin Yang, Ren-Gui Zhou
Sheng-Wei Cai, De-Jian Pan, Wei-Lin Yang, Ren-Gui Zhou, Department of Oncology, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Jin-Yan Chen, Department of Disinfection and Supply, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Rong Wan, Department of Quality Control, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Author contributions: Cai SW and Chen JY contributed equally to this work; Cai SW, Wan R, Pan DJ, and Chen JY designed the research study; Cai SW, Wan R, and Chen JY performed the research; Pan DJ, Yang WL, Zhou RG, and Chen JY contributed new reagents and analytic tools; Cai SW, Zhou RG, and Chen JY analyzed the data and wrote the manuscript; and all authors have read and approved the final manuscript.
Institutional review board statement: The study was approved by the Clinical Research Ethics Committees of Anhui Medical University Affiliated with Wuxi Clinical College (Approval number: YXLL-2020-003).
Informed consent statement: Before anyone was allowed to take part in the research project, we made sure that they (or their legal counsel) have provided informed consent to conduct the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: On reasonable request, the corresponding author can provide access to the utilized and processed datasets for this study.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Rong Wan, BHMS, Chief Nurse, Department of Quality Control, The 904th Hospital of Joint Logistic Support Force, No. 101 Xingyuan North Road, Wuxi 214044, Jiangsu Province, China. yings2007@21cn.com
Received: July 21, 2022
Peer-review started: July 21, 2022
First decision: August 4, 2022
Revised: August 16, 2022
Accepted: September 21, 2022
Article in press: September 21, 2022
Published online: November 6, 2022
Processing time: 97 Days and 17.9 Hours
Abstract
BACKGROUND

The new coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has produced a global pandemic of coronavirus disease 2019 (COVID-19), resulting in modifications to public health policies on a universal scale. SARS-CoV-2 vaccine has evolved as the most effective and secure way for protecting healthy individuals against COVID-19. Patients with cancer were excluded from clinical trials due to their increased COVID-19 risk and current immunosuppressing therapy. Safety and effectiveness evidence is insufficient for SARS-CoV-2 vaccination in cancer patients.

AIM

To assess the efficacy and safety of two-dose SARS-CoV-2 vaccines in cancer patients.

METHODS

A multicenter observational study was performed at ten Chinese hospitals between January 1, 2021 and December 31, 2021. Each participant in the research received two doses of vaccination. A total of 215 healthy people were screened and 132 eligible patients with cancer were recruited. In order to verify the safety of the second dose of the vaccine, a side-effect report was compiled. Two weeks following the second vaccination dose, subjects underwent an analogous questionnaire survey. Utilizing a magnetic particle-based chemiluminescence immunoassay, serum levels of anti-SARS-CoV-2 immunoglobulin G (IgG) antibodies were measured to determine the effectiveness of vaccination. IgG levels ≥ 10 AU/mL were considered seropositive.

RESULTS

All the 347 eligible patients completed the follow-up, and anti-SARS-CoV-2 IgG antibodies were detected. Local pain at the injection location was the most common side effect mentioned by all responders, with an increased incidence in cancer patients than the healthy people after the second dose vaccine (17.2% vs 9.1%; P = 0.035). There was no significant difference in headache, urticaria, or other adverse reactions between patients with cancer and healthy people. In the group of cancer patients, the seropositivity incidence was 83.3%, while it was 96.3% in the group of healthy people. In the group of cancer patients, the seropositivity incidence and antibody levels were significantly lower (P < 0.001). This analysis showed a poorer response rate in patients on active immunosuppressive treatment and elderly cancer patients.

CONCLUSION

Two-dose Chinese vaccines are effective and safe in cancer patients. However, further research is required on the efficacy in elderly cancer patients and those on active immunosuppressive treatment.

Keywords: SARS-CoV-2, Vaccine, Cancer, COVID-19, Immunotherapy

Core Tip: Newer strains of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have made the ongoing global coronavirus disease 2019 pandemic critical. Patients with cancer form a high-risk group, as those with active cancer or those treated with immunosuppressive therapies are more likely to be infected by SARS-CoV-2. Our study indicated the efficacy and safety of two-dose SARS-CoV-2 vaccines in cancer subjects.