Stadtmauer Edward A, Sullivan Keith M, Marty Francisco M, Dadwal Sanjeet S, Papanicolaou Genovefa A, Shea Thomas C, Mossad Sherif B, Andreadis Charalambos, Young Jo-Anne H, Buadi Francis K, El Idrissi Mohamed, Heineman Thomas C, Berkowitz Elchonon M
University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA;
Duke University Medical Center, Durham, NC;
Blood. 2014 Nov 6;124(19):2921-9. doi: 10.1182/blood-2014-04-573048. Epub 2014 Sep 18.
Recombinant herpes zoster (HZ) vaccines may be an alternative to the live-attenuated HZ vaccine for immunocompromised individuals. This was a phase 1/2, randomized, observer-blind, placebo-controlled study in adults with multiple myeloma, non-Hodgkin lymphoma (B- or T-cell), Hodgkin lymphoma, or acute myeloid leukemia who had undergone autologous hematopoietic stem-cell transplant 50 to 70 days earlier. Subjects (N = 121) were randomized 1:1:1:1 to receive (at months 0, 1, 3) three doses of 50 μg varicella-zoster virus glycoprotein E (gE) adjuvanted with AS01B, 3 doses of gE adjuvanted with AS01E, 1 dose of saline followed by 2 doses of gE/AS01B, or 3 doses of saline. One month after the last dose (6 months after transplant), frequencies of CD4(+) T cells expressing ≥2 activation markers after induction with gE and anti-gE antibody concentrations were higher with all gE/AS01 regimens than with saline. Both responses persisted up to 1 year in subjects vaccinated with gE/AS01. Immune responses were higher in the gE/AS01B 3-dose group than in the gE/AS01B 2-dose group but not higher than in the gE/AS01E 3-dose group. One serious adverse event (pneumonia) was considered vaccine related. Both formulations and both schedules were immunogenic and well tolerated in this population. This study was registered at www.clinicaltrials.gov as #NCT00920218.
重组带状疱疹（HZ）疫苗可能是免疫功能低下个体使用减毒活HZ疫苗的替代选择。这是一项1/2期、随机、观察者盲法、安慰剂对照研究，研究对象为患有多发性骨髓瘤、非霍奇金淋巴瘤（B细胞或T细胞）、霍奇金淋巴瘤或急性髓系白血病且在50至70天前接受过自体造血干细胞移植的成年人。受试者（N = 121）按1:1:1:1随机分组，分别接受（在第0、1、3个月）三剂50μg水痘-带状疱疹病毒糖蛋白E（gE）与AS01B佐剂联合使用、三剂gE与AS01E佐剂联合使用、一剂生理盐水后接两剂gE/AS01B或三剂生理盐水。最后一剂后1个月（移植后6个月），所有gE/AS01方案诱导后表达≥2种激活标志物的CD4(+) T细胞频率和抗gE抗体浓度均高于生理盐水组。在接种gE/AS01的受试者中，两种反应持续长达1年。gE/AS01B三剂组的免疫反应高于gE/AS01B两剂组，但不高于gE/AS01E三剂组。有1例严重不良事件（肺炎）被认为与疫苗有关。两种制剂和两种接种程序在该人群中均具有免疫原性且耐受性良好。本研究在www.clinicaltrials.gov上注册，注册号为#NCT00920218。
