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Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results.
Medina-Pestana, José; Covas, Dimas Tadeu; Viana, Laila Almeida; Dreige, Yasmim Cardoso; Nakamura, Monica Rika; Lucena, Elizabeth França; Requião-Moura, Lucio R; Fortaleza, Carlos Magno Castelo Branco; Foresto, Renato Demarchi; Tedesco-Silva, Helio; Cristelli, Marina Pontello.
  • Medina-Pestana J; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Covas DT; Instituto Butantan, São Paulo, Brazil.
  • Viana LA; Center for Cell-based Therapy (CTC), Regional Blood Center of Ribeirão Preto, University of São Paulo, São Paulo, Brazil.
  • Dreige YC; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Nakamura MR; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Lucena EF; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Requião-Moura LR; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Fortaleza CMCB; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Foresto RD; Infectious Diseases Division, Universidade Estadual Paulista (UNESP), Botucatu, Brazil.
  • Tedesco-Silva H; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Cristelli MP; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
Transplantation ; 106(4): 853-861, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1703621
ABSTRACT

BACKGROUND:

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 µg 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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Kidney Transplantation / COVID-19 Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Humans / Middle aged Language: English Journal: Transplantation Year: 2022 Document Type: Article Affiliation country: TP.0000000000004036

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Kidney Transplantation / COVID-19 Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Aged / Humans / Middle aged Language: English Journal: Transplantation Year: 2022 Document Type: Article Affiliation country: TP.0000000000004036