COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=130578

Lin Yuan

ynwsysy@walvax.com

2021-08-02

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Prevention

1. Healthy subjects aged 18 years and above who are 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 required, 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. For female subjects of childbearing potential, effective contraception should be used within 2 weeks prior to participation in this study and the pregnancy test is required to be negative (those with amenorrhea of at least 1 year or surgical sterilization verified by medical records could be exempted from the pregnancy test). Participants should voluntarily agree to continue using at least one effective method of contraception for 12 months after complete series (effective methods include oral contraceptives, injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.), 5. Axillary temperature <37.3? on the day of administration.

Exclusion criteria for first dose vaccination: 1. Women who are in the menstrual period (1st to 4th day of menstrual cramps) or breastfeeding on the day of vaccination, or men whose partners plan to become pregnant within 12 months from the screening period to the full immunization, or who plan to donate sperm and eggs By, 2. Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, have contact history with new coronavirus confirmed or suspected cases within 1 month before signing the informed consent form, or have high risk areas or overseas travel experience, or new coronavirus Infected persons or carriers: serum anti-SARS-CoV-2 IgG, IgM-specific antibodies are positive, or throat swab specimens are positive for SARS-CoV-2 nucleic acid, 3. Persons with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and human immunodeficiency virus antibody, 4. There is a history of SARS, MERS and other coronavirus infection or disease history, 5. Acute disease or acute exacerbation of chronic disease within 2 weeks before the first dose of vaccine, or fever (armpit temperature = 37.3?) or symptoms of upper respiratory tract infection within 7 days before the first dose of vaccine, 6. Previous history of alcohol or any serious adverse reactions to vaccines or drugs (for example: allergy, urticaria, skin eczema, allergic purpura, dyspnea, angioedema, etc.), or a history of acetaminophen allergy, 7. Have received any vaccine within 1 month before the first dose of vaccine, 8. Those who cannot tolerate venipuncture, those who have a history of fainting with needles and blood, 9. Has a hereditary bleeding tendency or coagulation dysfunction, or has a history of thrombosis or bleeding, and the test results of coagulation-related indicators are abnormal, 10. Has been diagnosed with congenital or acquired immunodeficiency (eg: HIV infection), 11. Asplenia, functional asplenia, and surgical removal of other vital organs for any reason, 12. Patients with abnormal clinical manifestations and serious diseases that need to be excluded in the past, 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., 13. Those who have undergone surgery within 3 months before signing the informed consent form, or those who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial or within 3 months after the end of the trial, 14. Those who donated blood or lost blood (=450 mL) within 3 months before signing the informed consent, received blood transfusion or used blood products, or planned to donate blood during the trial, 15. Have used any investigational or unregistered product (drug, vaccine, biological product or device) within 3 months before signing the informed consent, or plan to use it during the study, 16. 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

3

Walvax Biotechnology Co.; Ltd.

18

80

China

Healthy volunteers

N/A

360

IgG antibody;Neutralizing antibody as measured by pseudovirus neutralization assay;Neutralizing antibody as measured by wild-type virus neutralization assay;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "18-59 years", "treatment_id": 340, "treatment_name": "Covid19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": ">60 years", "treatment_id": 340, "treatment_name": "Covid19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]