1. Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial
- Author
-
Jesús Fortún, María Carmen Fariñas, José Miguel Montejo, Angel Bulnes-Ramos, Julián Torre-Cisneros, Clara M Rosso-Fernández, Elisa Cordero, Teresa Aydillo, Patricia Muñoz, Alejandro Suárez-Benjumea, Francisco López-Medrano, Pilar Pérez-Romero, Joan Gavaldà, N. Sabé, Marino Blanes-Julia, Cristina Roca-Oporto, Asunción Moreno, and Juliana Martinez-Atienza
- Subjects
Microbiology (medical) ,Male ,medicine.medical_specialty ,Influenza vaccine ,Population ,Booster dose ,Comorbidity ,030230 surgery ,Antibodies, Viral ,Immunomodulation ,03 medical and health sciences ,0302 clinical medicine ,Influenza A Virus, H1N1 Subtype ,Internal medicine ,Influenza, Human ,Odds Ratio ,Medicine ,Humans ,030212 general & internal medicine ,Seroconversion ,Adverse effect ,education ,education.field_of_study ,Booster (rocketry) ,business.industry ,Influenza A Virus, H3N2 Subtype ,Vaccination ,Immunity ,virus diseases ,Organ Transplantation ,Middle Aged ,Transplant Recipients ,Transplantation ,Influenza B virus ,Infectious Diseases ,Vaccines, Inactivated ,Influenza Vaccines ,Immunology ,Female ,business - 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
- Published
- 2016