COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=64449

Fengcai Zhu

jszfc@jscdc.cn

2020-11-17

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Aged 18 years and above, 2. Able to understand the content of informed consent and willing to sign the informed consent, 3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months), 4. Axillary temperature <=37.0 degree C, 5. General good health as established by medical history and physical examination.

1. Positive serum IgM and IgG to the SARS-CoV-2, 2. History of HIV infection 3. Family history of seizure, epilepsy, brain or mental disease. 4. Participant that has an allergic history to any ingredient of vaccines, 5. oman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months, 6. Any acute fever disease or infections, 7. Have a medical history of SARS, 8. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled, 9. Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled, 10. Hereditary angioneurotic edema or acquired angioneurotic edema, 11. Urticaria in last one year, 12. Asplenia or functional asplenia, 13. Platelet disorder or other bleeding disorder may cause injection contraindication, 14. Faint at the sight of blood or needles, 15. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months, 16. Prior administration of blood products in last 4 months, 17. Prior administration of other research medicines in last 1 month, 18. Prior administration of attenuated vaccine in last 1 month, 19. Prior administration of subunit vaccine or inactivated vaccine in last 14 days, 20. Being treated for tuberculosis, 21. Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.

5

West China Hospital; Sichuan University

18

85

China

Healthy volunteers

N/A

960

GMT of anti-RBD specific antibody at Month 1 after boost vaccination.;Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo;

| Declared number of arm (16.0) differs from found arms (17.0)

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "20 \u03bcg;2;18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "40 \u03bcg;2;18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20 \u03bcg;3;18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "40 \u03bcg;3;18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]