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Clin Infect Dis. 2017 Apr 1;64(7):829-838. doi: 10.1093/cid/ciw855.
Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial.
Cordero E1, Roca-Oporto C1, Bulnes-Ramos A1, Aydillo T1, Gavald? J2, Moreno A3, Torre-Cisneros J4, Montejo JM5, Fortun J6, Mu?oz P7, Sab? N8, Fari?as MC9, Blanes-Julia M10, L?pez-Medrano F11, Su?rez-Benjumea A12, Martinez-Atienza J1, Rosso-Fern?ndez C1, P?rez-Romero P1; TRANSGRIPE 1?2 Study Group.
Author information
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).
KEYWORDS:
booster dose.; immune response; influenza vaccine; solid organ transplantation
PMID: 28362949 DOI: 10.1093/cid/ciw855
Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial.
Cordero E1, Roca-Oporto C1, Bulnes-Ramos A1, Aydillo T1, Gavald? J2, Moreno A3, Torre-Cisneros J4, Montejo JM5, Fortun J6, Mu?oz P7, Sab? N8, Fari?as MC9, Blanes-Julia M10, L?pez-Medrano F11, Su?rez-Benjumea A12, Martinez-Atienza J1, Rosso-Fern?ndez C1, P?rez-Romero P1; TRANSGRIPE 1?2 Study Group.
Author information
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).
KEYWORDS:
booster dose.; immune response; influenza vaccine; solid organ transplantation
PMID: 28362949 DOI: 10.1093/cid/ciw855