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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
SARS-CoV Infection, Coronavirus Infection, Vaccine Adverse Reaction

Intervention / Treatment
-----------------
* Biological: Coronavac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 18 years old; Time after transplantation greater than 3 months; Time after treatment with anti-thymocyte globulin longer than 4 weeks; Able and willing (in the investigator's opinion) to comply with all study requirements; Provide written informed consent Exclusion Criteria: Planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination; 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); Administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine; Any history of angioedema or anaphylaxis; Pregnancy, lactation or willingness / intention to become pregnant during the study; Diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); History of severe psychiatric illness that possibly affects your participation in the study; Hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after IM injections or venipuncture; Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban); Current suspected or known addiction to alcohol or drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronavac vaccine<br>Kidney transplant recipients receiving the coronavac vaccine | Biological: Coronavac<br>* The CoronaVac is manufactured by Sinovac Life Sciences Co., Ltd. This vaccine contains the inactivated SARS-CoV-2 virus antigen and is administered intramuscularly.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of hospitalization or death in 28 days associated with COVID-19 (symptomatic cases confirmed virologically by COVID -19 with positive CRP) 14 ± 2 days after the second dose of the vaccine. |  | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of the vaccine on the incidence of COVID-19 according to the severity criterion of the World Health Organization. |  | 6 months | 
| Evaluate the impact of the vaccine on the incidence of COVID-19 and hospitalization for COVID-19 disease, confirmed by PCR, for a period of 6 months after the final vaccination. |  | 6 months | 
| Evaluate the vaccine's safety, tolerability, and reactogenicity profile: occurrence of signs and symptoms of local and systemic reactogenicity requested seven days after vaccination. |  | 7 days | 
| Evaluate the incidence of serious adverse events for a period of 6 months after the final vaccination. |  | 6 months | 
| Evaluate immunogenicity by detecting antibodies against SARS-CoV-2 for a period of 6 months after the final vaccination. | IgG antibody levels will be used to assess immunogenicity. | 6 months | 
| Analysis of the genetic sequencing of SARS-CoV-2 in patients who test positive for SARS-CoV-2 PCR. | Genetic sequencing of the virus will be carried out, that is, reading the genome of Sars-Cov-2, to evaluate possible new variants. | 6 months |