COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=130672

Lin Yuan

ynwsysy@walvax.com

2021-07-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1.Healthy adults aged 18 years and above. 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 be voluntary and capable of signing the informed consent form, 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.At risk of infection with or exposure to SARS-CoV-2 or COVID-19 cases due to factors regarding regions, occupations, activities, environment, etc., 5.For female subjects: no child-bearing potential or effective contraceptive measures have been used within 2 weeks before being included in this study with negative pregnancy test results. No child-bearing potential may include: amenorrhea for at least 1 year or surgical sterilization with medical records. Subjects shall voluntarily agree to continue using effective contraceptive measures with their partners through 3 months after completing Dose 2. Effective contraceptive measures include: abstinence or adequate contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraceptives, injectable or embedded contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, cervical cap, etc.), 6.Healthy subjects or subjects with mild underlying diseases [in a stable state for at least 3 months before enrollment without aggravation (no need for hospitalization or no major adjustment of treatment plan, etc.)].

1.Patients had history of COVID-19 or COVID-19 prophylactic drugs (e.g., history of any Novel Coronavirus vaccines marketed or not marketed), 2.Patients are tested positive for SARS-CoV-2 by etiological detection (RT-PCR). Subjects who are tested positive for IgG and/or IgM antibodies could be enrolled, 3.Patients had infection or disease history of human coronaviruses including SARS and MERS, 4.Patients have fever (axillary temperature >=37.3 degree C) on the day of Dose 1 or within recent 72 hours, 5.Females in pregnancy (e.g., those with positive pregnancy test results) or lactation period, 6.Planned pregnancy or interruption of effective contraceptive measures within 3 months after Dose 2 in this clinical trial, 7.Staff of the research institution and sponsor, 8.Patients have history of anaphylaxis or allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc., 9.Patients have been vaccinated with any vaccine within 28 days prior to the administration of Dose 1 in this study, 10.Patients have participated in or plan to participate in any clinical trials for other drugs from 28 days prior to the administration of Dose 1 to 12 months post Dose 2 in this study, 11.Patients have hereditary hemorrhagic tendency or coagulation dysfunction (such as cytokine deficiency, coagulation disorder or platelet disorder), or have a history of severe bleeding, or have a history of injuries caused by intramuscular injection or venipuncture, 12.Based on known history or diagnosis, those who are confirmed to have diseases that affect functions of the immune system, including cancer (except for basal cell carcinoma of the skin), congenital or acquired immunodeficiency (such as HIV infection), and uncontrollable autoimmune diseases, 13.Patients have asplenia or functional asplenia, 14.Patients are on long-term (continuous use for >= 14 days) immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs) within 6 months prior to the administration of Dose 1 in this study. Topical application (e.g., ointment, eye drops, inhalants or nasal sprays) is allowed. Dosage for topical medication should not exceed the recommended dose in the prescribing information, 15.Patients have received immunoglobulin and/or blood products within 3 months prior to the administration of Dose 1 in this study, 16.Patients have suspected or known alcohol dependence or drug abuse, which may have an impact on the safety evaluation or the subjects compliance, 17.Patients permanently move away from the study area prior to the end of the study or those who are away from the study area over a long period of time during the study follow-up, 18.Other factors that the investigator considered inappropriate for participation in the study.

2

Center for Disease Control and Prevention of Guangxi Zhuang Autonomous Region

18

100

China

Healthy volunteers

N/A

2000

IgG antibody;Neutralizing antibody;Cellular immunity;Cross neutralization;

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

Phase 3

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