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
- 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:
- 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: