Tumor
Conditions
Interventions
Group 1:Three doses of recombinant COVID-19 vaccines (Sf9 cells) were administrated sequentially on D0, D14, and D28
Group 2:One dose of recombinant COVID-19 vaccine (Sf9 cells) was administrated on D0
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old, before the start of any research procedure, voluntarily sign the ICF approved by the ethics committee and agree to participate in this research; 2. Tumor patients who are undergoing targeted therapy or immunotherapy or who have not received treatment during the follow-up period after medical history inquiry, physical examination and clinical diagnosis and treatment; 3. PS score = 6 months after the inactivated vaccine vaccination program approved in China (calculated as the last vaccination date is 0), and can provide relevant vaccination certificates; 5. Tumor patients who have not received domestically approved inactivated vaccines; 6. The expected survival period is >= 6 months, and they are able and willing to comply with the requirements of the clinical trial protocol and complete about 6 months of research follow-up; 7. Men and women of childbearing age who are of childbearing potential voluntarily use effective contraceptive measures (such as condoms, intrauterine devices, and spermicides) from signing the informed letter to 6 months after the vaccination is completed, and contraceptives are not allowed. Female tumor patients whose pregnancy test is negative agree not to breastfeed during the study period and for at least 3 months after vaccination with the test vaccine; 8. Axillary body temperature < 37.3°C.
Exclusion criteria
Exclusion criteria: 1. SARS-CoV-2 RT-PCR test positive at the time of screening; 2. History of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS) and other infection or disease history; 3. Those with previous medical history or family history of convulsions, epilepsy, encephalopathy or mental illness; 4. People who faint from needles; 5. Those who plan to become pregnant or donate sperm and eggs during the test period; 6. History of allergic reaction or allergic reaction to any vaccine and its auxiliary materials in the past, such as: allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc.; 7. Have received any vaccine within 30 days before inoculation of this study vaccine or plan to receive any other vaccines except this study vaccine during this study; 8. Participated in any other interventional experimental device or drug research within 30 days before screening, or is currently using other experimental drugs or within 5 half-lives after the last administration of the study drug; 9. Have hereditary bleeding tendency or abnormal coagulation function (such as cytokine deficiency, coagulation disorder or platelet disorder), or have a history of severe bleeding, or have a history of massive bleeding or ecchymosis after intramuscular injection or venipuncture; 10. According to the known medical history or diagnosis, it is confirmed to suffer from diseases that affect the function of the immune system, such as congenital or acquired immunodeficiency (for example: human immunodeficiency virus (HIV) infection), uncontrollable autoimmune diseases; 11. There are severe or uncontrollable respiratory diseases, cardiovascular diseases, nervous system diseases, blood and lymphatic system diseases, liver and kidney diseases, metabolic and bone system diseases that affect the evaluation of the results of this study judged by the researchers; 12. Asplenia or functional asplenia; 13. Long-term use (continuous use >= 14 days) of immunosuppressants or other immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within 6 months before vaccination of the vaccine used in this study, but local administration (such as ointment, eye drops, inhalation or nasal spray), topical application shall not exceed the dose recommended in the instructions or there are any signs of systemic exposure; 14. Received immunoglobulin and/or blood products within 3 months before inoculation with the experimental vaccine; 15. Patients who are undergoing anti-tuberculosis treatment; 16. According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the experimental protocol or affects the signing of informed consent by cancer patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Immunogenicity;Time, symptoms and severity of COVID-19 infection; | — |
Countries
China
Contacts
Public ContactYongsheng Wang
West China Hospital, Sichuan University
Outcome results
None listed