COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=63183

Lin Yuan

ynwsyl@walvax.com

2020-10-22

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Healthy adults aged 18-59 who can provide the legal identification of the subjects, both male and female, 2. The subjects knew the content of the informed consent and the vaccination situation, voluntarily signed the informed consent, and had the ability to use the thermometer, scale and fill in the diary card and contact card as required, 3. Those who can communicate well with researchers, and understand and comply with the requirements of this study, 4. The subjects with axillary temperature < 37.3 degree C on the day of inoculation.

Subjects meeting any of the following exclusion criteria were not included in the study 1. The subjects who did not meet the health standards in the comprehensive physical examination mainly included: (1) Patients with abnormal vital signs and clinical significance (awake pulse < 50 beats / min or > 100 beats / min, systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg), (2) Body mass index (BMI) < 18 kg / m2 or > 30 kg / m2, (3) 2 times of the upper or lower limit of the normal reference range, and the clinical significance was judged by the researchers, 2. Women with positive pregnancy test (those with menstrual period or amenorrhea for at least one year or surgical sterilization with medical records can be exempted from pregnancy test), or women in lactation period, or women planning to get pregnant within 12 months from screening period to full immunization, men planning to get pregnant with their partners, or those planning to donate sperm and eggs, 3. Female subjects in menstrual period (from the first day to the fourth day of menstruation) on the day of vaccination, 4. With novel coronavirus vaccination history, 5. Suspected cases of novel coronavirus pneumonia and suspected cases were found. There was a history of contact with new crown virus cases and suspected cases within 1 months prior to the signing of informed consent, or those with high incidence or overseas travel experience. Or new crown virus infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or throat swab samples SARS-CoV-2 nucleic acid positive. 6. Subjects with positive HBsAg, HCV core antigen, HCV antibody, Treponema pallidum specific antibody and HIV antibody, 7. Subjects with previous history of SARS, mers and other coronavirus infection or diseases, 8. The subjects who developed acute diseases within 2 weeks before the first dose of vaccine or were in the stage of acute attack of chronic diseases, or had fever (axillary temperature >= 37.3 degee C) or upper respiratory tract infection within 7 days before the first dose of vaccine, 9. Subjects with any history of severe side effects of vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 10. Objects who have received any vaccine within one month before the first dose of vaccine, 11. Those who can't tolerate venipuncture and have a history of needle and blood sickness, 12. Subjects with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators, 13. Persons who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection), 14. Subjects without spleen or functional spleen, and other important organs removed for any reason, 15. The objects with abnormal clinical manifestations and serious diseases that need to be excluded include but are not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.), 16. Subjects who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery during the trial or within 3 months after the trial (including cosmetic surgery, dental surgery and oral surgery), 17. The s

6

Shulan (Hangzhou) Hospital

18

59

China

Healthy volunteers

N/A

120

Specific IgG antibody;Neutralizing antibody;Cellular immunity;

| Declared number of arm (5.0) differs from found arms (6.0)

Phase 1

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "5ug;Number of doses is not reported", "treatment_id": 1927, "treatment_name": "Arcov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10ug;Number of doses is not reported", "treatment_id": 1927, "treatment_name": "Arcov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "15ug;Number of doses is not reported", "treatment_id": 1927, "treatment_name": "Arcov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20ug;Number of doses is not reported", "treatment_id": 1927, "treatment_name": "Arcov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "25ug;Number of doses is not reported", "treatment_id": 1927, "treatment_name": "Arcov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]