Nordic Research Network Oy, Tampere, Finland.
Jordan Ridge Kids & Teens, West Jordan, USA.
Vaccine. 2020 Dec 3;38(51):8224-8231. doi: 10.1016/j.vaccine.2020.10.036. Epub 2020 Nov 1.
Pediatric adjuvanted seasonal influenza vaccines induce higher immune responses and have the potential to confer better protection against influenza among young vaccine-naïve children. Limited data describe benefits and risks of repeated administration of adjuvanted influenza vaccines in children. Two revaccination studies assess the safety and immunogenicity of repeated exposure to an MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®) compared to routine non-adjuvanted quadrivalent influenza vaccine (QIV).
Children previously enrolled in the parent study, who received vaccination with aQIV or nonadjuvanted influenza vaccine (TIV or QIV), were recruited in Season 1 (n = 607) or Season 2 (n = 1601) of the extension trials. Season 1 participants remained in their original randomization groups (aQIV-aQIV or TIV-QIV); Season 2 subjects were re-randomized to either vaccine, resulting in four groups (aQIV-aQIV, aQIV-QIV, QIV-aQIV, or QIV-QIV). All subjects received a single-dose vaccination. Blood samples were taken for immunogenicity assessment prior to vaccination and 21 and 180 days after vaccination. Reactogenicity (Days 1-7) and safety were assessed in all subjects.
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2. Higher HI titers against heterologous influenza strains were observed after aQIV vaccination during both seasons. Mild to moderate severity and short duration reactogenicity was more common in the aQIV than QIV groups, but the overall safety profiles were similar to the parent study.
The safety and immunogenicity results from this study demonstrate benefit of aQIV for both priming and revaccination of children aged 12 months to 7 years.
儿科季节性流感佐剂疫苗可诱导更高的免疫应答，并有可能为年轻的初种儿童提供更好的流感保护。关于重复接种佐剂流感疫苗的益处和风险，仅有有限的数据进行了描述。两项再接种研究评估了重复使用 MF59 佐剂四价流感疫苗（aQIV；Fluad®）与常规非佐剂四价流感疫苗（TIV 或 QIV）相比的安全性和免疫原性。
先前参加过母体研究、接种过 aQIV 或非佐剂流感疫苗（TIV 或 QIV）的儿童在扩展试验的第 1 季（n=607）或第 2 季（n=1601）入组。第 1 季参与者保持其原始随机分组（aQIV-aQIV 或 TIV-QIV）；第 2 季受试者重新随机分组至任一疫苗，共形成 4 个组（aQIV-aQIV、aQIV-QIV、QIV-aQIV 或 QIV-QIV）。所有受试者均接受了单剂疫苗接种。在接种前、接种后 21 天和 180 天采集血样进行免疫原性评估。所有受试者均评估了不良反应（第 1-7 天）和安全性。
在第 1 季和第 2 季，血凝抑制（HI）几何平均滴度（GMT）比值均显示 aQIV 再接种优于 QIV 再接种，对所有株系均如此，对 A/H1N1、B/Yamagata 和 B/Victoria 株系更是如此。在两个季节中，接种 aQIV 后均可观察到针对异源流感株系的更高 HI 滴度。在 aQIV 组中，较常见的是轻至中度严重程度和短暂的不良反应，但总体安全性与母体研究相似。
本研究的安全性和免疫原性结果表明，aQIV 可用于 12 月龄至 7 岁儿童的初种和再接种。
