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Study on safety and immune response characteristics of inactivated COVID-19 vaccine inoculated on solid organ transplant recipients

Study on safety and immune response characteristics of inactivated COVID-19 vaccine inoculated on solid organ transplant recipients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049037
Enrollment
Unknown
Registered
2021-07-20
Start date
2021-07-25
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

test group:No

Sponsors

The Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Solid organ transplant recipients; 2. One dose of inactivated COVID-19 vaccine has been administered, and the second dose has not yet been administered; 3. Aged 18 to 65, male or female; 4. No serious infectious diseases such as severe pneumonia or severe immune dysfunction such as acute rejection occurred in at least 3 months; 5. Informed consent of the patient and written consent.

Exclusion criteria

Exclusion criteria: 1. People who are allergic to the active substance in the COVID-19 vaccine, any inactive substance or substance used in the preparation process, or who have developed allergies to previous COVID-19 vaccination; 2, Allergic physique; 3. Patients with fever or acute disease; 4. Complicated with serious heart and lung diseases; 5. Pregnant and lactating women, as well as women of reproductive age who do not wish to use contraception; 6. As judged by the investigator, subjects are unlikely to comply with the study visit arrangement or have a history of poor compliance; 7. Subjects have medical or psychiatric conditions that, as judged by the Investigator, may affect compliance.

Design outcomes

Primary

MeasureTime frame
neutralizing antibody;T cell response;Renal graft function;

Secondary

MeasureTime frame
urine protein;peripheral blood leucocyte;peripheral blood lymphocyte;

Countries

China

Contacts

Public ContactChen Zheng

The Second Affiliated Hospital of Guangzhou Medical University

docchenzheng@163.com+86 13808896300

Outcome results

None listed

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