Bahakel Hannah, Spieker Andrew J, Hayek Haya, Schuster Jennifer E, Hamdan Lubna, Dulek Daniel E, Kitko Carrie L, Stopczynski Tess, Batarseh Einas, Haddadin Zaid, Stewart Laura S, Stahl Anna, Potter Molly, Rahman Herdi, Amarin Justin, Kalams Spyros A, Bocchini Claire E, Moulton Elizabeth A, Coffin Susan E, Ardura Monica I, Wattier Rachel L, Maron Gabriela, Grimley Michael, Paulsen Grant, Harrison Christopher J, Freedman Jason, Carpenter Paul A, Englund Janet A, Munoz Flor M, Danziger-Isakov Lara, Halasa Natasha
Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Ohio.
Department of Biostatistics, Vanderbilt University Medical Center.
J Infect Dis. 2025 Feb 4;231(1):e123-e131. doi: 10.1093/infdis/jiae454.
Pediatric hematopoietic cell transplant (HCT) recipients are at high risk for morbidity from influenza virus infection. We demonstrated in a primary phase 2 randomized controlled trial that 2 post-HCT doses of high-dose trivalent influenza vaccine (HD-TIV) given 4 weeks apart were more immunogenic than 2 doses of standard-dose quadrivalent influenza vaccine (SD-QIV). Herein, we present the immunogenicity and safety of influenza vaccination in a consecutive season post-HCT using the same dosing regimen.
A subcohort of study participants reenrolled and had hemagglutinin inhibition titers measured at baseline and 4 weeks after each vaccine dose in year 2. We estimated geometric mean fold rise in hemagglutinin inhibition titer from baseline for each group and used linear mixed effects models to estimate adjusted geometric mean ratios (comparing HD-TIV vs SD-QIV) for each antigen at each time point. We described systemic and injection site reactions.
A total of 65 subcohort patients participated (33 SD-QIV, 32 HD-TIV). Postvaccine geometric mean fold rise and adjusted geometric mean ratio estimates were higher for both groups following a single influenza vaccine dose in year 2 as compared with 2 doses of the same formulation in year 1. Both groups had similar frequencies of injection site and systemic reactions.
A single dose of HD-TIV or SD-QIV was more immunogenic in year 2 than 2 doses of the same formulation in year 1. Reactogenicity was comparable between groups. One dose of influenza vaccine may be sufficient after a 2-dose schedule in the prior year post-HCT.
NCT02860039 (ClinicalTrials.gov).
小儿造血细胞移植（HCT）受者因感染流感病毒而发病的风险很高。我们在一项2期初级随机对照试验中证明，间隔4周接种2剂高剂量三价流感疫苗（HD-TIV）的HCT受者比接种2剂标准剂量四价流感疫苗（SD-QIV）的免疫原性更强。在此，我们介绍了采用相同给药方案在HCT后连续一个季节进行流感疫苗接种的免疫原性和安全性。
研究参与者的一个亚组重新入组，并在第2年每次疫苗接种后4周和基线时测量血凝素抑制滴度。我们估计了每组血凝素抑制滴度相对于基线的几何平均升高倍数，并使用线性混合效应模型估计每个时间点每种抗原的调整几何平均比率（比较HD-TIV与SD-QIV）。我们描述了全身和注射部位反应。
共有65名亚组患者参与（33名接种SD-QIV，32名接种HD-TIV）。与第1年接种2剂相同配方疫苗相比，第2年接种单剂流感疫苗后，两组的疫苗接种后几何平均升高倍数和调整几何平均比率估计值均更高。两组的注射部位和全身反应频率相似。
第2年单剂HD-TIV或SD-QIV的免疫原性高于第1年接种2剂相同配方疫苗。两组之间的反应原性相当。在前一年HCT后采用2剂接种方案后，一剂流感疫苗可能就足够了。
NCT02860039（ClinicalTrials.gov）。
