Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients

• Conditions: Kidney Transplantation; SARS-CoV-2 Acute Respiratory Disease; Vaccine

• Registration Number: NCT04969614
• Lead Sponsor: West China Hospital

Brief Summary

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has a major impact on transplant recipients, with mortality rates up to 20%. However, immunocompromised individuals have been excluded from studies of SARS-CoV-2 vaccines. In such patients, the immune response to vaccination may be blunted. To better understand the immunogenicity of SARS-CoV-2 vaccines in transplant recipients, we quantified the humoral response to SARS-CoV-2 vaccine in kidney transplant recipients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20
• Study Start: 2021-08-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Receiving kidney transplantation in West China Hospital, Sichuan University

Exclusion Criteria

1. History of rejection or infection over the previous 3 months; 2) receiving kidney transplantation >3 months; 3) Combined with HBV/HVC/HIV infection in the donor or recipient; 4) Malignancy history in the donor and recipient; 5) organ transplant history in the recipient.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
seropositive anti-COVID-19 antibody	2 to 6 weeks after the second injection of inactivated vaccine	seropositive anti-COVID-19 antibody, including IgM, IgG, and IgA