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

Phase 4

• Conditions: Coronavirus Infection; Vaccine Adverse Reaction; SARS-CoV Infection
• Interventions: Biological: Coronavac

• Registration Number: NCT04801667
• Lead Sponsor: Hospital do Rim e Hipertensão

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Study Start: 2021-03-20
• Primary Completion: 2021-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3371

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronavac vaccine	Coronavac	Kidney transplant recipients receiving the coronavac vaccine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.	6 months	IgG antibody levels will be used to assess immunogenicity.
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
Analysis of the genetic sequencing of SARS-CoV-2 in patients who test positive for SARS-CoV-2 PCR.	6 months	Genetic sequencing of the virus will be carried out, that is, reading the genome of Sars-Cov-2, to evaluate possible new variants.

Trial Locations

Locations (1)

Hospital do Rim - Fundação Oswaldo Ramos; 🇧🇷 São Paulo, Brazil