title: Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial.
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.
  
  
  BACKGROUND
  EudraCT (2011-003243-21).
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Elisa
authors.initials: E
authors.lastname: Cordero
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Cristina
authors.initials: C
authors.lastname: Roca-Oporto
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Angel
authors.initials: A
authors.lastname: Bulnes-Ramos
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Teresa
authors.initials: T
authors.lastname: Aydillo
authors.affiliation: Vall d'Hebron University Hospital.
authors.forename: Joan
authors.initials: J
authors.lastname: Gavaldà
authors.affiliation: University Clinic Hospital, Barcelona.
authors.forename: Asunción
authors.initials: A
authors.lastname: Moreno
authors.affiliation: 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.
authors.forename: Julián
authors.initials: J
authors.lastname: Torre-Cisneros
authors.affiliation: Cruces University Hospital, Bizkaia.
authors.forename: Jose Miguel
authors.initials: JM
authors.lastname: Montejo
authors.affiliation: University Hospital Ramón y Cajal, Madrid.
authors.forename: Jesús
authors.initials: J
authors.lastname: Fortun
authors.affiliation: 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.
authors.forename: Patricia
authors.initials: P
authors.lastname: Muñoz
authors.affiliation: University Hospital of Bellvitge, Infectious Diseases Research Group, L'Hospitalet de Llobregat, Barcelona.
authors.forename: Nuria
authors.initials: N
authors.lastname: Sabé
authors.affiliation: University Hospital Marqués de Valdecilla, Santander.
authors.forename: Maria Carmen
authors.initials: MC
authors.lastname: Fariñas
authors.affiliation: University Hospital La Fe, Valencia.
authors.forename: Marino
authors.initials: M
authors.lastname: Blanes-Julia
authors.affiliation: University Hospital 12 de Octubre, Instituto de Investigación Biomédica i+12, Madrid; and.
authors.forename: Francisco
authors.initials: F
authors.lastname: López-Medrano
authors.affiliation: University Hospital Virgen Macarena, Seville, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Suárez-Benjumea
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Juliana
authors.initials: J
authors.lastname: Martinez-Atienza
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Clara
authors.initials: C
authors.lastname: Rosso-Fernández
authors.affiliation: Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville, University Hospitals Virgen del Rocío/CSIC/University of Seville.
authors.forename: Pilar
authors.initials: P
authors.lastname: Pérez-Romero
mesh_terms: D000914:Antibodies, Viral / Q000276:immunology; D015897:Comorbidity; D005260:Female; D006801:Humans; D007109:Immunity; D056747:Immunomodulation; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D016377:Organ Transplantation; D066027:Transplant Recipients; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: booster dose.; immune response; influenza vaccine; solid organ transplantation