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The immunogenicity of medium-dose or high-dose CoronaVac vaccine booster

The immunogenicity of medium-dose or high-dose CoronaVac vaccine administered as a booster dose in adults vaccinated with two doses of CoronaVac vaccine 5-9 months before: a randomized, double-blind, phase IV clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052697
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-10-28
Completion date
Unknown
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Experimental group1:medium-dose CoronaVac vaccine booster
Experimental group2:high-dose CoronaVac vaccine booster

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged >= 18 years; 2. Individuals who could justify legal identification; 3. Individuals able to understand and voluntarily sign an informed consent form, and willing to follow the research plan to complete the trial; 4. Individuals vaccinated with two dose of CoronaVac vaccine 5-9 months before.

Exclusion criteria

Exclusion criteria: 1. Individuals with history of COVID-19 (laboratory confirmed); 2. Individuals with any other factors that are not suitable for participating in the clinical trial based on the judgment of the investigator; 3. Individuals with severe adverse reactions in the basic immunity of the new crown vaccine, such as urticaria, dyspnea, and angioedema; 4. Individuals with autoimmune diseases (such as systemic lupus erythematosus) or in an immunodeficiency/immunosuppressive state (such as AIDS, after organ transplantation); 5. Individuals with severe chronic diseases, such as severe cardiovascular disease, high blood pressure that cannot be controlled by drugs, diabetes, liver and kidney disease, malignant tumors, etc.; 6. Individuals with severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; 7. Individuals with abnormal coagulation function (such as deficiency of coagulation factors, coagulopathy, abnormal platelet) or obvious bruising or coagulation disorder diagnosed by a doctor; 8. Individuals who received immunosuppressant therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months, or plans to receive the above treatment during the study period; 9. Individuals with history of long-term alcohol or drug abuse; 10. Individuals who received blood products within 3 months, or plans to receive the above treatment during the study period; 11. Individuals received other investigational drugs within 30 days; 12. Individuals received live attenuated vaccine against COVID-19 within 14 days, or received subunit or inactivated vaccine against COVID-19 within 7 days; 13. Individuals with various acute or acute Onset of chronic disease in the past 7 days; 14. Individuals with axillary temperature > 37.0 degree; 15. Individuals who participated in other clinical trials and being during the follow-up period, or plans to participate in other clinical trials during the study period.

Design outcomes

Primary

MeasureTime frame
Serum neutralizing antibody;

Countries

China

Contacts

Public ContactFeng Yingmei

Beijing Youan Hospital, Capital Medical University

yingmeif13@sina.com+86 10 83997022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026