Trial NCT04352608
Publication Zhang Y,Lancet Infect Dis,2020
Dates: 5/3/2020 to 5/5/2020
Funding: Mixed (National Key Research and Development Program, Beijing Science and Technology Program)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / China Follow-up duration (days): 43 | |
| Inclusion criteria | Healthy adults aged 18-59 years; Proven legal identity; Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment |
| Exclusion criteria | Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days; History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days; Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days; Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days; Self-reported history of SARS; Self-reported history of new coronavirus infection; Positive in serum antibodies (IgG or IgM) screening of COVID-19; Positive in nasopharyngeal swabs or anal swabs through RT-PCR; Women who are breastfeeding, pregnant or planning to become pregnant during the study period; BMI?35 kg/m2; History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Autoimmune disease or immunodeficiency / immunosuppression; Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.; Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months; Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials); History of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs in the past 30 days; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Attacks of acute diseases or chronic diseases in the past 7 days; Axillary temperature >37.0°C; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial |
| Interventions | |
| Treatment 1 CoronaVac 3 mcg D0/14 | |
| Control Adjuvant | |
| Treatment 3 CoronaVac 6 mcg D0/14 | |
| Treatment 4 CoronaVac 3 mcg D0/28 | |
| Treatment 5 CoronaVac 6 mcg D0/28 | |
| Participants | |
| Randomized 600 participants | |
| Characteristics of participants Type of participants: Healthy volunteers N=600 Adults: 600 Children: 0 Pregnant women: 0 HIV patients: 0 Health care workers: 0 Participants close contacts to COVID-19 patients: 0 Mean age : 42.1 282 males | |
| Description of participants Healthy SARS-CoV-2 serology/DNA negative adults in a single centre in China | |
| Primary outcome | |
| In the register 1) Safety indexes of adverse reactions [ Time Frame: From the beginning of the vaccination to 28 days after the whole schedule vaccination]; 2) Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule ?day 0,14? [ Time Frame: The 14th day after two doses of vaccination]; 3) Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule (day 0,28) [ Time Frame: The 28th day after two doses of vaccination ] | |
| In the report 1) Any adverse reactions within 28 days after each dose of study drug; 2) Seroconversion of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 vaccination cohort, or day 28 after the last dose in the days 0 and 28 vaccination cohort | |
| Documents avalaible |
Protocol No Statistical plan No Data-sharing stated Y |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | * |