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

Hospital do Rim e Hipertensão

Status and phase: Unknown; Phase 4

Conditions: Vaccine Adverse Reaction; SARS-CoV Infection; Coronavirus Infection

Treatments: Biological: Coronavac

Study type: Interventional

Funder types: Other

Identifiers

NCT04801667

TxR Coronavac - Hrim

Details and patient eligibility

About

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.

Enrollment: 3,371 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults over 18 years old;
2. Time after transplantation greater than 3 months;
3. Time after treatment with anti-thymocyte globulin longer than 4 weeks;
4. Able and willing (in the investigator's opinion) to comply with all study requirements;
5. Provide written informed consent

Exclusion criteria

1. Planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination;
2. Prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by Adenovirus, any vaccines against coronavirus);
3. Administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine;
4. Any history of angioedema or anaphylaxis;
5. Pregnancy, lactation or willingness / intention to become pregnant during the study;
6. Diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);
7. History of severe psychiatric illness that possibly affects your participation in the study;
8. Hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after IM injections or venipuncture;
9. Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);
10. Current suspected or known addiction to alcohol or drugs.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,371 participants in 1 patient group

Coronavac vaccine

Experimental group

Description:

Kidney transplant recipients receiving the coronavac vaccine

Treatment:

Biological: Coronavac