COVID-19, Patients With Cancers, Vaccine
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALCoronavirus vaccine
Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively
Sponsors
Beijing 302 Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of coronavirus vaccine | Within 2 months after the first dose of coronavirus vaccine | Occurence of adverse effects after COVID-19 vaccination |
| Immunogenicity of coronavirus vaccine | Within 2 months after the first dose of coronavirus vaccine | Titers of anti-SARS-CoV-2 antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of coronavirus vaccine | Within 13 months after the first dose of coronavirus vaccine | Occurence of adverse effects after COVID-19 vaccination |
| Immunogenicity of coronavirus vaccine | Within 13 months after the first dose of coronavirus vaccine | Titers of anti-SARS-CoV-2 antibodies |
Countries
China
Contacts
Primary ContactFu-Sheng Wang, MD
Backup ContactRuonan Xu, MD
Outcome results
None listed