tetano
Editor, Senior Moderator
Clin Infect Dis. 2017 Apr 1;64(7):829-838. doi: 10.1093/cid/ciw855.
[h=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.[/h] Cordero E[SUP]1[/SUP], Roca-Oporto C[SUP]1[/SUP], Bulnes-Ramos A[SUP]1[/SUP], Aydillo T[SUP]1[/SUP], Gavald? J[SUP]2[/SUP], Moreno A[SUP]3[/SUP], Torre-Cisneros J[SUP]4[/SUP], Montejo JM[SUP]5[/SUP], Fortun J[SUP]6[/SUP], Mu?oz P[SUP]7[/SUP], Sab? N[SUP]8[/SUP], Fari?as MC[SUP]9[/SUP], Blanes-Julia M[SUP]10[/SUP], L?pez-Medrano F[SUP]11[/SUP], Su?rez-Benjumea A[SUP]12[/SUP], Martinez-Atienza J[SUP]1[/SUP], Rosso-Fern?ndez C[SUP]1[/SUP], P?rez-Romero P[SUP]1[/SUP]; TRANSGRIPE 1?2 Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] Influenza vaccine effectiveness is not optimal in solid organ transplant recipients (SOTR). We hypothesized that a booster dose might increase it.
[h=4]Methods:[/h] 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.
[h=4]Results:[/h] 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.
[h=4]Conclusions:[/h] 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.
[h=4]Clinical Trials Registration:[/h] EudraCT (2011-003243-21).
[h=4]KEYWORDS:[/h] booster dose.; immune response; influenza vaccine; solid organ transplantation
PMID: 28362949 DOI: 10.1093/cid/ciw855
[h=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.[/h] Cordero E[SUP]1[/SUP], Roca-Oporto C[SUP]1[/SUP], Bulnes-Ramos A[SUP]1[/SUP], Aydillo T[SUP]1[/SUP], Gavald? J[SUP]2[/SUP], Moreno A[SUP]3[/SUP], Torre-Cisneros J[SUP]4[/SUP], Montejo JM[SUP]5[/SUP], Fortun J[SUP]6[/SUP], Mu?oz P[SUP]7[/SUP], Sab? N[SUP]8[/SUP], Fari?as MC[SUP]9[/SUP], Blanes-Julia M[SUP]10[/SUP], L?pez-Medrano F[SUP]11[/SUP], Su?rez-Benjumea A[SUP]12[/SUP], Martinez-Atienza J[SUP]1[/SUP], Rosso-Fern?ndez C[SUP]1[/SUP], P?rez-Romero P[SUP]1[/SUP]; TRANSGRIPE 1?2 Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] Influenza vaccine effectiveness is not optimal in solid organ transplant recipients (SOTR). We hypothesized that a booster dose might increase it.
[h=4]Methods:[/h] 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.
[h=4]Results:[/h] 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.
[h=4]Conclusions:[/h] 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.
[h=4]Clinical Trials Registration:[/h] EudraCT (2011-003243-21).
[h=4]KEYWORDS:[/h] booster dose.; immune response; influenza vaccine; solid organ transplantation
PMID: 28362949 DOI: 10.1093/cid/ciw855