Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results

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Autor(es): dc.contributorUniversidade Federal de São Paulo (UNIFESP)-
Autor(es): dc.contributorInst Butantan-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.creatorMedina-Pestana, Jose-
Autor(es): dc.creatorCovas, Dimas Tadeu-
Autor(es): dc.creatorViana, Laila Almeida-
Autor(es): dc.creatorDreige, Yasmim Cardoso-
Autor(es): dc.creatorNakamura, Monica Rika-
Autor(es): dc.creatorLucena, Elizabeth Franca-
Autor(es): dc.creatorRequiao-Moura, Lucio R.-
Autor(es): dc.creatorBranco Fortaleza, Carlos Magno Castelo [UNESP]-
Autor(es): dc.creatorForesto, Renato Demarchi-
Autor(es): dc.creatorTedesco-Silva, Helio-
Autor(es): dc.creatorCristelli, Marina Pontello-
Data de aceite: dc.date.accessioned2022-08-04T21:58:35Z-
Data de disponibilização: dc.date.available2022-08-04T21:58:35Z-
Data de envio: dc.date.issued2022-04-28-
Data de envio: dc.date.issued2022-04-28-
Data de envio: dc.date.issued2022-04-01-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1097/TP.0000000000004036-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/218590-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/218590-
Descrição: dc.descriptionBackground. Anti-severe acute respiratory syndrome coronavirus 2 mRNA vaccines elicit lower humoral responses in solid-organ transplant recipients. This is the first prospective trial investigating the effect of an inactivated whole-virion vaccine in kidney transplant recipients. Methods. Prospective, single-center, phase 4, interventional study. Kidney transplant recipients aged 30-69 y with >30 d of transplantation received two 3 mu g intramuscular doses of CoronaVac 28 d apart and are being followed for 6 mo. Primary outcomes: (1) reactogenicity after first dose; (2) antibody responses 28 d after each dose; and (3) incidence/severity of confirmed coronavirus disease 2019 (COVID-19) and 28-d lethality rate. For this analysis, clinical effectiveness was assessed for 3 mo, starting 15 d after the second dose, and compared with 3-mo period before vaccination. Results. Of the 3371 individuals who received the first dose, 99% completed vaccination schedule. Mild/local adverse reactions were reported by 33% of the patients. In the immunogenicity cohort (n = 942), the proportion of patients with IgG antibodies to severe acute respiratory syndrome coronavirus 2 increased from 15.2% after first dose to 43% after second dose. Increase in antibody values after second dose was associated with higher proportion of patients with detected neutralizing antibodies. A significant reduction in the incidence of COVID-19 was observed (6.4% versus 4.2%; P < 0.0001), although the 28-d lethality rate remained unchanged (25% versus 22%; P = 0.534). In 45 patients from the immunogenicity cohort who developed COVID-19, all the 6 deaths occurred among those without antibody response (n = 22; 49%). Conclusions. CoronaVac vaccine was associated with low reactogenicity, low immunogenicity but reduced incidence of COVID-19 among kidney transplant recipients. The lack of reduction in lethality rates is perhaps associated with the low percentage of patients developing humoral response after the second dose.-
Descrição: dc.descriptionUniv Fed Sao Paulo UNIFESP, Hosp Rim, Nephrol Div, Borges Lagoa 960, BR-04038002 Sao Paulo, SP, Brazil-
Descrição: dc.descriptionInst Butantan, Sao Paulo, Brazil-
Descrição: dc.descriptionUniv Sao Paulo, Ctr Cell Based Therapy CTC, Reg Blood Ctr Ribeirao Preto, Sao Paulo, Brazil-
Descrição: dc.descriptionUniv Estadual Paulista, Infect Dis Div, UNESP, Botucatu, SP, Brazil-
Descrição: dc.descriptionUniv Estadual Paulista, Infect Dis Div, UNESP, Botucatu, SP, Brazil-
Formato: dc.format853-861-
Idioma: dc.languageen-
Publicador: dc.publisherLippincott Williams & Wilkins-
Relação: dc.relationTransplantation-
???dc.source???: dc.sourceWeb of Science-
Título: dc.titleInactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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