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Abstract: Background: Influenza vaccine effectiveness is not optimal in solid organ transplant recipients (SOTR). We hypothesized that a booster dose might increase it. Methods: TRANSGRIPE 1-2 is a phase 3, randomized, controlled, multicenter, open-label clinical trial. Patients were randomly assigned (1:1 stratified by study site, type of organ, and time since transplantation) to receive 1 dose (control group) or 2 doses (booster group) of the influenza vaccine 5 weeks apart. Results: A total of 499 SOTR were enrolled. Although seroconversion at 10 weeks did not meet significance in the modified intention-to-treat population, seroconversion rates were significantly higher in the booster arm for the per-protocol population (53.8% vs 37.6% for influenza A(H1N1)pdm; 48.1% vs 32.3% for influenza A(H3N2); and 90.7% vs 75% for influenza B; P < .05). Furthermore, seroprotection at 10 weeks was higher in the booster group: 54% vs 43.2% for A(H1N1)pdm; 56.9% vs 45.5% for A(H3N2); and 83.4% vs 71.8% for influenza B (P < .05). The number needed to treat to seroprotect 1 patient was <10. The clinical efficacy (99.2% vs 98.8%) and serious adverse events (6.4% vs 7.5%) were similar for both groups. Conclusions: In SOTR, a booster strategy 5 weeks after standard influenza vaccination is safe and effective and induces an increased antibody response compared with standard influenza vaccination consisting of a single dose. CLINICAL TRIALS REGISTRATION: EudraCT (2011-003243-21).
Fuente: Clinical Infectious Diseases, 2017, 64(7), 829-838
Editorial: Oxford University Press
Fecha de publicación: 01/04/2017
Nº de páginas: 10
Tipo de publicación: Artículo de Revista
DOI: 10.1093/cid/ciw855
ISSN: 1058-4838,1537-6591
Leer publicación
CORDERO, ELISA
ROCA OPORTO, CRISTINA
BULNES RAMOS, ANGEL
AYDILLO, TERESA
GAVALDÀ, JOAN
MORENO, ASUNCIÓN
TORRE CISNEROS, JULIÁN
MONTEJO, JOSE MIGUEL
FORTUN, JESÚS
MUÑOZ, PATRICIA
SABÉ, NURIA
MARIA DEL CARMEN FARIÑAS ALVAREZ
MARIA RAQUEL DURAN CALVO
FELIPE ZURBANO GOÑI
MANUEL COBO BELAUSTEGUI
FERNANDO CASAFONT MORENCOS
FÁBREGAS GARCÍA, EMILIO
CARLOS ARMIÑANZAS CASTILLO
LUIS MARTINEZ MARTINEZ
GONZÁLEZ RICO, CLAUDIA
SONIA MARIA FERNANDEZ ROZAS
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