NCT04801667

Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients

Prospective Study in a Single Center to Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,371 (actual)
• Sponsor: Hospital do Rim e Hipertensão · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reaching 53% among those over 70 years old. Among the survivors, there is also a high incidence of renal dysfunction with loss of the renal graft and definitive return to dialysis. Patients receiving pharmacological immunosuppression, including transplant recipients, have not been included in the studies carried out to date. In addition, kidney transplant recipients may have reduced vaccine responses compared to the general population. The severity, the high incidence of renal dysfunction and loss of renal graft, and the high lethality associated with COVD-19 justify the investigation of the epidemiological impact and immunogenicity of the vaccine against SARS-CoV-2 infection.

Conditions

• SARS-CoV Infection
• Coronavirus Infection
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	Coronavac	The CoronaVac is manufactured by Sinovac Life Sciences Co., Ltd. This vaccine contains the inactivated SARS-CoV-2 virus antigen and is administered intramuscularly.

Timeline

• Start date: 2021-03-20
• Primary completion: 2021-10-01
• Completion: 2023-03-01
• First posted: 2021-03-17
• Last updated: 2022-03-18

Locations

1 site across 1 country: Brazil