Safety, immunogenicity, and tolerability of three influenza vaccines in older adults Results of a randomized, controlled comparison
Safety, immunogenicity, and tolerability of three influenza vaccines in older adults Results of a randomized, controlled comparison
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DOI：
10.4161/hv.25580
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发表时间：
2013-11-01
影响因子：
4.8
通讯作者：
Halperin, Scott A.
中科院分区：
文献类型：
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作者：
Scheifele, David W.;McNeil, Shelly A.;Halperin, Scott A.
为了确定新的流感疫苗是否可以安全地提高老年人的血清保护率，我们在一项随机对照试验中比较了三种获得许可的三价灭活疫苗（TIV），评价者设盲。参与者为≥ 65岁的非虚弱成年人，每年接受一次IV免疫。研究疫苗包括具有相同效力和菌株组成的皮内（IDV）、MF 59佐剂（ADV）和亚单位（TIV）制剂。在接种前（V1）、接种后21（V2）和180 d（V3）采集血液，并通过血凝抑制（HAI）试验进行检测。参与者每天完成安全性日记，并提出关于注射和症状的具体耐受性问题。总共有911名参与者接受了免疫接种，887名（97.4%）完成了V3。两组的人口统计学特征相似。接种后的一般症状发生率在各组之间相似。IDV/ADV/TIV后注射部位发红的发生率分别为75%/13%/13%，疼痛的发生率分别为29%/38%/20%，但每种疫苗的耐受性良好，症状几乎不引起麻烦。基线抗体滴度在组间无显著差异，但B/布里斯班滴度过高，无法进行有意义的缓解评估。在V2时，ADV后的血清保护率（HAI滴度>= 40）最高，对H3 N2和H1N1的保护率分别为11.8%和11.4%和10.2%和12.5%，明显优于IDV和TIV。在第180天，血清保护率下降了25%，各组之间不再有显著差异。虽然IDV和TIV的耐受性也很好，但ADV在接种后3周而不是6个月时诱导老年人对甲型流感病毒株的抗体滴度适度升高。该人群对IDV和TIV的免疫应答相似。
To determine if newer influenza vaccines can safely improve seroprotection rates of older adults, we compared three licensed trivalent inactivated vaccines (TIVs) in a randomized, controlled trial with evaluator blinding. Participants were non-frail adults >= 65 y old, annually TIV-immunized. Study vaccines included intradermal (IDV), MF59-adjuvanted (ADV) and subunit (TIV) formulations of equal potency and strain composition. Blood was obtained before vaccination (V1) and 21 (V2) and 180 d (V3) afterward and tested by hemagglutination inhibition (HAI) assay. Safety diaries were completed daily by participants and specific tolerability questions were posed regarding injections and symptoms. In total, 911 participants were immunized and 887 (97.4%) completed V3. Groups had similar demographics. General symptom rates post-vaccination were similar among groups. Rates of injection site redness after IDV/ADV/TIV were 75%/13%/13% and rates of pain were 29%/38%/20%, respectively, but each vaccine was well tolerated, with symptoms causing little bother. Baseline antibody titers did not differ significantly among groups but B/Brisbane titers were too high for meaningful response assessments. At V2, seroprotection rates (HAI titer >= 40) were highest after ADV, the rate advantage over IDV and TIV being significant at 11.8% and 11.4% for H3N2 and 10.2% and 12.5% for H1N1, respectively. At day 180, seroprotection rates had declined similar to 25% and no longer differed significantly among groups. While IDV and TIV were also well tolerated, ADV induced modestly higher antibody titers in seniors to influenza A strains at 3 weeks but not 6 months post-vaccination. Immune responses to IDV and TIV were similar in this population.