Clinical Trials Logo
  1. Home
  2. Kidney Transplantation
  3. NCT04969614
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT02723591 - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients Phase 4
Completed NCT05945511 - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed NCT02234349 - Bile Acids and Incretins in Pancreas Kidney Transplant Patients N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Not yet recruiting NCT05934383 - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension N/A
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Not yet recruiting NCT04540640 - Oxygenated Machine Preservation in Kidney Transplantation N/A
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Completed NCT02560558 - Bela 8 Week Dosing Phase 4
Terminated NCT02417870 - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation Phase 1/Phase 2
Recruiting NCT02154815 - Pre-emptive Kidney Transplantation Quality of Life N/A
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Enrolling by invitation NCT01905514 - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients N/A
Completed NCT02147210 - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 N/A
Recruiting NCT01699360 - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2