NCT04969614

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 19, 2021

Last Update Submit

July 19, 2021

Conditions

Kidney TransplantationSARS-CoV-2 Acute Respiratory DiseaseVaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

kidney transplant recipients

kidney transplant recipients receiving inactivated SARS-CoV-2 vaccine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients receiving kidney transplantation in West China Hospital between 01/01/2015 and 01/03/2021

You may qualify if:

  • Receiving kidney transplantation in West China Hospital, Sichuan University

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
West China Hospital

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 20, 2021

Study Start

August 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07