Elisa Cordero1, Cristina Roca-Oporto1, Angel Bulnes-Ramos1, Teresa Aydillo1, Joan Gavaldà2, Asunción Moreno3, Julián Torre-Cisneros4, Jose Miguel Montejo5, Jesús Fortun6, Patricia Muñoz7, Nuria Sabé8, Maria Carmen Fariñas9, Marino Blanes-Julia10, Francisco López-Medrano11, Alejandro Suárez-Benjumea12, Juliana Martinez-Atienza1, Clara Rosso-Fernández1, Pilar Pérez-Romero1. 1. Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville. 2. Vall d'Hebron University Hospital. 3. University Clinic Hospital, Barcelona. 4. Maimonides Biomedical Research Institute of Cordoba, Reina Sofia University Hospital (Clinic Unit of Infectious Diseases and Clinic Unit Preventive Medicine and Public Health), University of Cordoba. 5. Cruces University Hospital, Bizkaia. 6. University Hospital Ramón y Cajal, Madrid. 7. Gregorio Marañón University Hospital, Instituto de Investigación Sanitaria Hospital Gregorio Marañón, CIBER Enfermedades Respiratorias-CIBERES, and Department of Medicine, School of Medicine, Universidad Complutense de Madrid, Spain Hospital Majadahonda, Madrid. 8. University Hospital of Bellvitge, Infectious Diseases Research Group, L'Hospitalet de Llobregat, Barcelona. 9. University Hospital Marqués de Valdecilla, Santander. 10. University Hospital La Fe, Valencia. 11. University Hospital 12 de Octubre, Instituto de Investigación Biomédica i+12, Madrid; and. 12. University Hospital Virgen Macarena, Seville, Spain.
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).
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).
Authors: Carol M Kao; Kristina Lai; John M McAteer; Mohnd Elmontser; Elizabeth M Quincer; Marianne E M Yee; Ashley Tippet; Robert C Jerris; Peter A Lane; Evan J Anderson; Nitya Bakshi; Inci Yildirim Journal: Pediatr Blood Cancer Date: 2020-05-29 Impact factor: 3.167
Authors: David Cucchiari; Natalia Egri; Marta Bodro; Sabina Herrera; Jimena Del Risco-Zevallos; Joaquim Casals-Urquiza; Frederic Cofan; Asunción Moreno; Jordi Rovira; Elisenda Banon-Maneus; Maria J Ramirez-Bajo; Pedro Ventura-Aguiar; Anna Pérez-Olmos; Marta Garcia-Pascual; Mariona Pascal; Anna Vilella; Antoni Trilla; José Ríos; Eduard Palou; Manel Juan; Beatriu Bayés; Fritz Diekmann Journal: Am J Transplant Date: 2021-08-04 Impact factor: 9.369