Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronavac vaccine | Experimental | Kidney transplant recipients receiving the coronavac vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronavac | Biological | The CoronaVac is manufactured by Sinovac Life Sciences Co., Ltd. This vaccine contains the inactivated SARS-CoV-2 virus antigen and is administered intramuscularly. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital do Rim - Fundação Oswaldo Ramos | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34974453 | Derived | 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. | |
| 34882589 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Derived |
| 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. |
| 34292214 | Derived | 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. |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |