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

Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients: a Prospective Cohort Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04969614

Enrollment

300

Registered

2021-07-20

Start date

2021-08-01

Completion date

2021-12-01

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, SARS-CoV-2 Acute Respiratory Disease, Vaccine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results