COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=122800

Lin Yuan

ynwsysy@walvax.com

2021-05-23

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Prevention

1. Healthy individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required). 2. Individuals who are able to understand the contents in the informed consent form and information about the investigational vaccine used in this study, willing to sign the informed consent form, able to use the thermometer, scale as well as fill in the diary card and contact card as required. 3. Individuals who are able to communicate with the investigators, able and willing to understand and comply with all study requirements. 4. For female participants 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 agrees to continue using at least one effective methods of contraception for 12 months after full immunization (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 screening.

1. Women who are in the menstrual period (day 1 to day 4 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 period, or plan to donate sperm and eggs, 2. Those who have a history of new coronavirus vaccination, 3. People who have been diagnosed with new coronavirus pneumonia cases or suspected cases, have contact history with confirmed or suspected cases of new coronavirus within 1 month before signing the informed consent, or have travel experience in high-risk areas of the epidemic or overseas, 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, 4. Those who test positive for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and human immunodeficiency virus antibody, 5. A history of SARS, MERS and other human coronavirus infections or disease history, 6. Acute illness or acute onset of chronic disease occurred within 2 weeks before the first dose of vaccine, or fever (axillary body temperature =37.3?) or symptoms of upper respiratory tract infection within 7 days before the first dose of vaccine, 7. Past alcohol or history of serious adverse reactions to any vaccine or drugs (for example: allergies, urticaria, skin eczema, allergic purpura, dyspnea, angioedema, etc.), or history of allergy to acetaminophen, 8. Have received any vaccine within 1 month before the first dose of vaccine, 9. Those who cannot tolerate venipuncture, and those who have a history of fainting needles and bleeding, 10. Have hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis or hemorrhagic disease, and the test results of coagulation function-related indicators are abnormal, 11. Has been diagnosed with congenital or acquired immunodeficiency (for example: HIV infection), 12. No spleen, functional no spleen, and surgical removal of other important organs for any reason, 13. Severe diseases that have abnormal clinical manifestations and 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, bones and other system diseases And the history of malignant tumors, excluding the history of stable chronic diseases, such as diabetes, hypertension, etc., 14. Those who have undergone surgery within 3 months before signing the informed consent, or who plan to undergo surgery during the trial period or within 3 months after the end of the trial (including cosmetic surgery, dental surgery and oral surgery), 15. Those who donate blood or lose blood (>=450 mL) within 3 months before signing the informed consent, receive blood transfusion or use blood products, or plan to donate blood during the trial period, 16. Any research or unregistered products (drugs, vaccines, biological products or devices) have been used within 3 months before signing the informed consent, or planned to be used during the research period, 17. Receive immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term application of systemic glucocorticoid therapy (for more than 2 consecutive weeks in 6 months, application of systemic glucocorticoid therapy, such as prednisone or

2

Yunnan Walvax Biotechnology Co.; Ltd.

18

80

China

Healthy volunteers

N/A

60

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

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

Phase 1

[{"arm_notes": "5\u00d710^10vp;18-59 years old and >= 60 years old", "treatment_id": 1958, "treatment_name": "Chadts-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]