Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial
Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial
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DOI：
10.1093/cid/ciw855
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发表时间：
2017-04-01
影响因子：
11.8
通讯作者：
Perez-Romero, Pilar
中科院分区：
文献类型：
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作者：
Cordero, Elisa;Roca-Oporto, Cristina;Perez-Romero, Pilar
背景资料。在实体器官移植受者(SOTR)中，流感疫苗的效果并不理想。我们假设加强剂量可能会增加它。方法。TRANSGRIPE 1-2是一项3期随机、对照、多中心、开放标签的临床试验。患者被随机分配(按研究地点、器官类型和移植后时间1：1分层)，每隔5周接种1剂(对照组)或2剂(加强组)流感疫苗。共有499名学生参加了该项目。虽然10周的血清转阴率在改良的意向治疗人群中没有达到显著意义，但在按方案实施的加强组人群中，血清转换率显著更高(甲型H1N1流感丙型流感疫苗的53.8%比37.6%；甲型H3N1流感病毒的48.1%比32.3%；乙型流感病毒的90.7%比75%；P<；0.05)。此外，加强组在10周时的血清保护率更高：A(H1N1)PDM的54%比43.2%；A(H3N2)的56.9%比45.5%；B型流感的83.4%比71.8%(P<；0.05)。需要治疗以保护1例患者的个数为10。两组的临床有效率(99.2%比98.8%)和严重不良反应(6.4%比7.5%)相似。在SOTR中，标准流感疫苗接种后5周的加强免疫策略是安全有效的，与单剂标准流感疫苗相比，它能诱导更高的抗体反应。
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.