COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=126502

Lin Yuan

ynwsysy@walvax.com

2021-08-02

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Prevention

1. Healthy subjects aged 60 years and above who were capable of providing legal identities. Both males and females should be included, 2. The subjects shall fully understand the content of the informed consent form and the study procedure of this clinical trial. The subjects shall voluntarily sign the informed consent form. The subjects shall be capable of using the thermometer and scale, as well as filling in the Diary Card/Contact Card as require, 3. The subjects shall be able to communicate well with the investigators, as well as understand and comply with the requirements of this study, 4. Female subjects with amenorrhea for at least 1 year or surgical sterilization verified by medical records, 5. Axillary temperature <37.3 degree C on the day of administration.

1. Men whose partner plans to become pregnant within 12 months from the screening period to the full immunization, 2. Those with a history of new coronavirus vaccination, 3. Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, have a history of contact with confirmed or suspected cases of new coronavirus within 1 month before signing the informed consent form, or have travel experience in high-risk areas or overseas, or new coronavirus Infected person or carrier: positive for anti-SARS-CoV-2 specific antibody in serum, or positive for SARS-CoV-2 nucleic acid in throat swab specimen, 4. Persons with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and human immunodeficiency virus antibody, 5. There is a history of SARS, MERS and other coronavirus infection or disease history, 6. Those with acute disease or acute exacerbation of chronic disease within 7 days before the first dose of vaccine, or fever (armpit temperature = 37.3?) or symptoms of upper respiratory tract infection within 3 days before the first dose of vaccine, 7. Have any history of serious adverse reactions to vaccines or drugs, such as: allergy, urticaria, skin eczema, dyspnea, angioedema, etc., 8. Have received any vaccine within 1 month before the first dose of vaccine, 9. Those who cannot tolerate venous blood collection, and those who have a history of fainting with needles and haemorrhage, 10. Has hereditary bleeding tendency or coagulation dysfunction, or has a history of thrombosis or hemorrhage, and the test results of coagulation function-related indicators are abnormal, 11. Has been diagnosed with congenital or acquired immunodeficiency (eg: HIV infection), 12. Asplenia, functional asplenia, and surgical removal of other vital organs for any reason, 13. Previous serious diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system and history of malignant tumors, excluding history of stable chronic diseases, such as diabetes, hypertension, etc., 14. Those who have undergone surgery within 3 months before signing the informed consent form, or those who plan to undergo surgery during the trial, 15. Have used any investigational or unregistered products (drugs, vaccines, biological products or devices) other than this research vaccine within 3 months before signing the informed consent, or plan to use it during the study, 16. Individuals who have used any investigational or unlicensed products (drugs, vaccines, biological products or devices) other than investigational vaccines within 3 months prior to signing the informed consent form, or plan to use the above-mentioned products during the study period, 17. Received immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term application of systemic glucocorticoid therapy (systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs ), but topical application (such as ointment, eye drops, inhaler or nasal spray) is allowed, and topical application should not exceed the dose recommended in the instructions or have any signs of systemic exposure, 18. There are other circumstances that t

2

Shanxi Provincial Center for Disease Control and Prevention

60

100

China

Healthy volunteers

N/A

320

IgG antibody;Neutralizing antibody;Cellular immunity;

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

Phase 1/Phase 2

[{"arm_notes": "phase I", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "phase II", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "phase II", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]