Clinical trial NCT04801667: Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients
Official title: Prospective Study in a Single Center to Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: SARS-CoV Infection
Coronavirus Infection
Vaccine Adverse Reaction
Lead sponsor: Hospital do Rim e Hipertensão
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 3371
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 45 days
Secondary outcomes:
measure: Evaluate the impact of the vaccine on the incidence of COVID-19 according to the severity criterion of the World Health Organization.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Evaluate the vaccine's safety, tolerability, and reactogenicity profile: occurrence of signs and symptoms of local and systemic reactogenicity requested seven days after vaccination.
timeFrame: 7 days
measure: Evaluate the incidence of serious adverse events for a period of 6 months after the final vaccination.
timeFrame: 6 months
measure: Evaluate immunogenicity by detecting antibodies against SARS-CoV-2 for a period of 6 months after the final vaccination.
timeFrame: 6 months
measure: Analysis of the genetic sequencing of SARS-CoV-2 in patients who test positive for SARS-CoV-2 PCR.
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Rim - Fundação Oswaldo Ramos
Study officials:
References:
citation: Medina-Pestana J, Covas DT, Viana LA, Dreige YC, Requiao-Moura LR, Nakamura MR, Lucena EF, Foresto RD, Tedesco-Silva H, Cristelli MP. Homologous Third Dose of Inactivated Whole-virion Vaccine Fails to Elicit a Robust Immune Response Among Kidney Seronegative Transplant Recipients. Transplantation. 2022 May 1;106(5):e284-e285. doi: 10.1097/TP.0000000000004029. Epub 2021 Dec 28. No abstract available.
citation: Medina-Pestana J, Covas DT, Viana LA, Dreige YC, Nakamura MR, Lucena EF, Requiao-Moura LR, Fortaleza CMCB, Foresto RD, Tedesco-Silva H, Cristelli MP. Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results. Transplantation. 2022 Apr 1;106(4):853-861. doi: 10.1097/TP.0000000000004036.
citation: Medina-Pestana J, Cristelli MP, Viana LA, Foresto RD, Requiao-Moura LR, Tedesco-Silva H, Covas DT. Clinical Impact, Reactogenicity, and Immunogenicity After the First CoronaVac Dose in Kidney Transplant Recipients. Transplantation. 2022 Jan 1;106(1):e95-e97. doi: 10.1097/TP.0000000000003901. No abstract available.