COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=120494

Yuquan Wei

yqwei@vip.sina.com

2021-01-21

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Aged 18-85 years, 2. Obtain the informed consent of the subjects and sign the informed consent form, 3. Subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 14 months. -Axillary body temperature <= 37.0 degree C.

1. The 2019 novel coronavirus antibody (IgG and IgM) screening is positive. 2. The 2019 novel coronavirus nucleic acid test is positive. 3. 2019 new coronavirus infection history and 2019 new coronavirus vaccination history. 4. Known history of HIV infection. 5. Those with medical or family history of convulsions, epilepsy, encephalopathy, and mental illness. 6. Those who are allergic to any ingredient in the research vaccine, have a history of severe vaccine allergic reactions and allergies in the past. 7. Women who have a positive urine pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan during the study period (within 14 months). 8. Patients with acute febrile diseases and infectious diseases. 9. Those who self-report a history of SARS. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medication, etc. 10. Suffer from severe chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as asthma, diabetes, thyroid disease, etc. 11. Malignant tumors, active tumors or tumors that have been treated without clear cure, or may recur during the study period. -Congenital or acquired angioedema/neuroedema. 12. Had urticaria 1 year before receiving the trial vaccine, 13. Aspleen or functional aspleen, 14. Suffer from thrombocytopenia or other coagulation disorders (may cause contraindication to intramuscular injection), 15. Fainted needles, 16. Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis), 17. Received blood products within 4 months before receiving the test vaccine, 18. Received other study drugs within 1 month before receiving the test vaccine, 19. Received a live attenuated vaccine within 1 month before receiving the test vaccine, 20. Received subunit or inactivated vaccine within 14 days before receiving the test vaccine, 21. The onset of various acute or chronic diseases in the past 7 days, such as being receiving anti-tuberculosis treatment and a history of asthma, 22. According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol or affects the subjects to sign informed consent.

4

Jiangsu Provincial Center for Disease Control and Prevention

18

85

China

Healthy volunteers

N/A

4800

The incidence of adverse reactions (AR) 0-7 days after each immunization;The incidence of Adverse Events of Special Concern (AESI) from the first to 60 days after the last immunization;

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "3;Days0-21-42;Adult group", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3;Days0-21-42;Elder group", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3;Days0-21-42;Immunogenic group", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3;Days0-21-42;Immunogenic group", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]