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

NCT ID: NCT04969614

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-12-01

Brief Summary

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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

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Conditions

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Kidney Transplantation SARS-CoV-2 Acute Respiratory Disease Vaccine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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kidney transplant recipients

kidney transplant recipients receiving inactivated SARS-CoV-2 vaccine

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tao Lin

West China Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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WestChina-COVID

Identifier Type: -

Identifier Source: org_study_id

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