COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05165732

Qiuyue Mu

Not reported

2021-12-21

Suspended

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: adults aged 18-45; proven legal identity; the subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan; have completed two doses of sars-cov-2 inactivated vaccine vaccination for 6 to 8 months(the interval between the two doses vaccine of primary immunization is 21~35 days, and the two doses vaccine of primary immunization should be manufactured by the same manufactures).

history of sars-cov-2 infection(laboratory confirmed); have received inactivated sars-cov-2 vaccine from other manufacturers other than sinovac life sciences co., ltd.,beijing institute of biological products co.,ltd.and wuhan institute of biological products co.,ltd.and received three and more doses of inactivated sars-cov-2 vaccine; severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization; autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as aids, post-transplant; severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc; severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; 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 noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; 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 other investigational drugs in the past 30 days; receipt of attenuated live vaccines in the past 14 days; acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination; axillary temperature >37.0°c; already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results); participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period; according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

5

Sinovac Research and Development Co., Ltd.

18

45

China

Healthy volunteers

N/A

480

Immunogenicity index-GMT of neutralizing antibodies;Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies;Immunogenicity index-seropositive rate of neutralizing antibody

None

Phase 4

[{"arm_notes": "600SU;previously received Coronavac", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "600SU;previously received Bbibp-corv", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "4ug;previously received Bbibp-corv", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "600SU;previously received Inactivated sars-cov-2 vaccine (vero cell)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "200WU; previously received Inactivated sars-cov-2 vaccine (vero cell)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]