高剂量流感疫苗与MF59佐剂流感疫苗及标准流感疫苗在实体器官移植受者中的免疫原性：瑞士/西班牙实体器官移植预防流感试验（STOP-FLU试验）
Immunogenicity of High-Dose Versus MF59-Adjuvanted Versus Standard Influenza Vaccine in Solid Organ Transplant Recipients: The Swiss/Spanish Trial in Solid Organ Transplantation on Prevention of Influenza (STOP-FLU Trial).
作者信息
Mombelli Matteo, Neofytos Dionysios, Huynh-Do Uyen, Sánchez-Céspedes Javier, Stampf Susanne, Golshayan Dela, Dahdal Suzan, Stirnimann Guido, Schnyder Aurelia, Garzoni Christian, Venzin Reto M, Magenta Lorenzo, Schönenberger Melanie, Walti Laura, Hirzel Cédric, Munting Aline, Dickenmann Michael, Koller Michael, Aubert John-David, Steiger Jürg, Pascual Manuel, Mueller Thomas F, Schuurmans Macé, Berger Christoph, Binet Isabelle, Villard Jean, Mueller Nicolas J, Egli Adrian, Cordero Elisa, van Delden Christian, Manuel Oriol
机构信息
Transplantation Center, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Service of Infectious Diseases, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
出版信息
Clin Infect Dis. 2024 Jan 25;78(1):48-56. doi: 10.1093/cid/ciad477.
BACKGROUND
The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so new vaccination strategies are needed in this population.
METHODS
Adult SOT recipients from 9 transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. Patients were randomized (1:1:1) to a MF59-adjuvanted or a high-dose vaccine (intervention), or a standard vaccine (control), with stratification by organ and time from transplant. The primary outcome was vaccine response rate, defined as a ≥4-fold increase of hemagglutination-inhibition titers to at least 1 vaccine strain at 28 days postvaccination. Secondary outcomes included polymerase chain reaction-confirmed influenza and vaccine reactogenicity.
RESULTS
A total of 619 patients were randomized, 616 received the assigned vaccines, and 598 had serum available for analysis of the primary endpoint (standard, n = 198; MF59-adjuvanted, n = 205; high-dose, n = 195 patients). Vaccine response rates were 42% (84/198) in the standard vaccine group, 60% (122/205) in the MF59-adjuvanted vaccine group, and 66% (129/195) in the high-dose vaccine group (difference in intervention vaccines vs standard vaccine, 0.20; 97.5% confidence interval [CI], .12-1); P < .001; difference in high-dose vs standard vaccine, 0.24 [95% CI, .16-1]; P < .001; difference in MF59-adjuvanted vs standard vaccine, 0.17 [97.5% CI, .08-1]; P < .001). Influenza occurred in 6% of the standard, 5% in the MF59-adjuvanted, and 7% in the high-dose vaccine groups. Vaccine-related adverse events occurred more frequently in the intervention vaccine groups, but most of the events were mild.
CONCLUSIONS
In SOT recipients, use of an MF59-adjuvanted or a high-dose influenza vaccine was safe and resulted in a higher vaccine response rate.
CLINICAL TRIALS REGISTRATION
Clinicaltrials.gov NCT03699839.
背景
实体器官移植（SOT）受者中标准流感疫苗的免疫原性降低，因此该人群需要新的疫苗接种策略。
方法
来自瑞士和西班牙9家移植诊所的成年SOT受者，若移植后超过3个月则纳入研究。患者按1:1:1随机分组，接受含MF59佐剂的疫苗或高剂量疫苗（干预组），或标准疫苗（对照组），并按器官和移植时间分层。主要结局为疫苗应答率，定义为接种疫苗后28天血凝抑制效价至少对1种疫苗株升高≥4倍。次要结局包括聚合酶链反应确诊的流感和疫苗反应原性。
结果
共619例患者随机分组，616例接受了分配的疫苗，598例有血清可用于分析主要终点（标准组，n = 198；含MF59佐剂组，n = 205；高剂量组，n = 195例患者）。标准疫苗组的疫苗应答率为42%（84/198），含MF59佐剂疫苗组为60%（122/205），高剂量疫苗组为66%（129/195）（干预疫苗组与标准疫苗组的差异，0.20；97.5%置信区间[CI]，.12 - 1）；P <.001；高剂量疫苗组与标准疫苗组的差异，0.24 [95% CI，.16 - 1]；P <.001；含MF59佐剂疫苗组与标准疫苗组的差异，0.17 [97.5% CI，.08 - 1]；P <.001）。标准疫苗组6%的患者、含MF59佐剂疫苗组5%的患者和高剂量疫苗组7%的患者发生了流感。干预疫苗组疫苗相关不良事件发生更频繁，但大多数事件为轻度。
结论
在SOT受者中，使用含MF59佐剂的流感疫苗或高剂量流感疫苗是安全的，且疫苗应答率更高。
临床试验注册
Clinicaltrials.gov NCT03699839。
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