Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.
This study is a prospective, single-arm, open-label clinical trial. A total of 300 patients
with different cancers including hepatocellular carcinoma, breast cancer, lung cancer,
esophageal cancer, gastric cancer and colorectal cancer were included in this vaccination
study. All of the patients will further accept 12 months follow-up study after vaccination.
Safety and immunogenicity will be carefully recorded and detected.
Biological: Coronavirus vaccine
Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively
Inclusion Criteria:
1. Age above 18 years
2. Patients with diagnosed cancers including hepatocellular carcinoma, breast cancer,
lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included .
3. Patients who have received local or systemic anti-cancer therapies according to the
treatment guidelines previously or currently, and have a stable condition with the
ECOG score below 2.
4. The functions of multi-organs were normal or basically normal, and there are no
contraindications for vaccination.
Exclusion Criteria:
1. Patients with acute attack of chronic diseases.
2. Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
3. Patients who are allergic to any component of the vaccine, or have a serious history
of vaccine allergy.
4. Pregnant or lactating women.
5. Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block,
myocardial infarction, and severe hypertension can not be well controlled by drugs.
6. Patients have severe chronic diseases or diseases can not be controlled well during
the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired
angioedema / neuroedema.
7. Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer
cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing, China
Investigator: Fu-Sheng Wang, MD
Contact: 01066933328
fswang302@163.com
Investigator: Fu-Sheng Wang, MD
Fu-Sheng Wang, MD
8610-66933332
fswang@163.com
Ruonan Xu, MD
8610-66933333
xuruonan2004@aliyun.com
Shu-juan Li, MD, Study Director
Beijing 302 Hospital