Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial

Fecha de publicación: 01/04/2017

Autores de IIS La Fe

Marino Blanes Juliá

Autor

Participantes ajenos a IIS La Fe

Cordero, E
Roca-Oporto, C
Bulnes-Ramos, A
Aydillo, T
Gavalda, J
Moreno, A
Torre-Cisneros, J
Montejo, JM
Fortun, J
Munoz, P
Sabe, N
Farinas, MC
Lopez-Medrano, F
Suarez-Benjumea, A
Martinez-Atienza, J
Rosso-Fernandez, C
Perez-Romero, P
TRANSGRIPE 1-2 Study Group

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.

Datos de la publicación

ISSN/ISSNe:: 1058-4838, 1537-6591
Tipo:: Article
Páginas:: 829-838
DOI:: 10.1093/cid/ciw855
Factor de Impacto:: 5,051 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Filiaciones

Cordero, E:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
Roca-Oporto, C:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
Bulnes-Ramos, A:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
Aydillo, T:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
Gavalda, J:: Vall dHebron Univ Hosp, Barcelona, Spain
Moreno, A:: Univ Clin Hosp, Barcelona, Spain
Torre-Cisneros, J:: Univ Cordoba, Reina Sofia Univ Hosp, Maimonides Biomed Res Inst Cordoba, Cordoba, Spain
Montejo, JM:: Cruces Univ Hosp, Bizkaia, Spain
Fortun, J:: Univ Hosp Ramon & Cajal, Madrid, Spain
Munoz, P:: Univ Hosp Gregorio Maranon, Inst Invest Sanitaria Hosp Gregorio Maranon, CIBER Enfermedades Respirat CIBERES, Madrid, Spain

Univ Complutense Madrid, Sch Med, Dept Med, Madrid, Spain
Sabe, N:: Univ Hosp Bellvitge, Reg Infect Dis Grp, Hosp Lobregat, Barcelona, Spain
Farinas, MC:: Univ Hosp Marques Valdecilla, Santander, Spain
Blanes-Julia, M:: Univ Hosp La Fe, Valencia, Spain
Lopez-Medrano, F:: Univ Hosp 12 Octubre, Inst Invest Biomed I 12, Madrid, Spain
Suarez-Benjumea, A:: Univ Hosp Virgen Macarena, Seville, Spain
Martinez-Atienza, J:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
Rosso-Fernandez, C:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
Perez-Romero, P:: Univ Seville, Univ Hosp Virgen Racio CSIC, Inst Biomed Seville, Clin Unit Infect Dis, Seville, Spain
TRANSGRIPE 1-2 Study Group:: TRANSGRIPE 1-2 Study Group