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NCT04969614 Clinical Trial

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

Kidney Transplantation Clinical Trial

Official title:
Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04969614
Other study ID # WestChina-COVID
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date December 1, 2021

Study information
Verified date July 2021
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary seropositive anti-COVID-19 antibody seropositive anti-COVID-19 antibody, including IgM, IgG, and IgA 2 to 6 weeks after the second injection of inactivated vaccine
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