COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=119719

Lin Yuan

ynwsysy@walvax.com

2021-01-08

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Prevention

1. A healthy person aged 18-59 who can provide the legal identification of the subjects, both male and female, 2. The subjects who knew the content of 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. Subjects who can communicate well with researchers and understand and comply with the requirements of this study, four The subjects who had used effective contraceptive measures within 2 weeks before being enrolled in this study had negative pregnancy test (those with amenorrhea for at least 1 year or surgical sterilization with medical records could be exempted from pregnancy test), and voluntarily agreed to continue to use effective contraceptive measures within 12 months after full immunization, such as oral contraceptive, injection or embedded contraceptive, slow-release local contraceptive, hormone patch, intrauterine contraceptive IUD, sterilization, condom (male), diaphragm, cervical cap, etc, 5. Subjects with axillary temperature < 37.3 degrees C on the day of inoculation.

1. Those who do not meet the health standards in the comprehensive physical examination mainly include: (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 who are in menstrual period (day 1-4) or lactation period, or women who plan to get pregnant within 12 months from screening period to full immunization, men who plan to get pregnant with their partners, or those who plan to donate sperm and eggs, 3. subjects with a history of New Coronavirus vaccination, 4. there were cases of suspected cases of New Coronavirus pneumonia and suspected cases, and 1 months before signing the informed consent. There were people who had contact with COVID-19 cases and suspected cases, or those with high incidence or overseas travel experience, or those with COVID-19 infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or SARS-CoV-2 nucleic acid positive in throat swabs. 5. Patients with positive etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), syphilis or HIV, 6. Patients with previous history of SARS, mers and other coronavirus infection or diseases, 7. Patients with acute disease or acute attack of chronic disease within 2 weeks before the first dose of vaccine, or with fever (axillary temperature > 37.3 degrees C) or upper respiratory tract infection within 7 days before the first dose of vaccine, 8. Subjects with any history of severe adverse reactions of vaccine or drug, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 9. Subjects who had received any vaccine within one month before the first dose of vaccine, 10. Patients who can't tolerate venipuncture and have a history of needle and blood sickness, 11. Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators, 12. Patients who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection), 13. Subjects without spleen, functional spleen, and other important organs removed for any reason, 14. Patients with previous severe diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.), 15. Patients who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial period or within 3 months after the end of the trial, 16. Subjects who donated or lost blood (>= 450 ml) within 3 months before signing the informed consent, who received blood transfusion or used blood products, or planned to donate blood during the trial, 17. Any research or unregistered products (drugs, vaccines, biological products or devices) other than the research vaccine were used or planned to be used during t

4

Yunnan Walvax Biotechnology Co.; Ltd.

18

59

China

Healthy volunteers

N/A

420

IgG antibody;Neutralizing antibody;

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 2

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