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

Sponsor
West China Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04969614
Collaborator
(none)
300
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients: a Prospective Cohort Study
    Anticipated Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    kidney transplant recipients

    kidney transplant recipients receiving inactivated SARS-CoV-2 vaccine

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • West China Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tao Lin, West China Hospital, West China Hospital
    ClinicalTrials.gov Identifier:
    NCT04969614
    Other Study ID Numbers:
    • WestChina-COVID
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Jul 20, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2021