O'Grady Kerry-Ann F, Chang Anne B, Cripps Allan, Mulholland Edward K, Smith-Vaughan Heidi, Wood Nicholas, Danchin Margaret, Thornton Ruth, Wilson Andrew, Torzillo Paul J, Morris Peter M, Richmond Peter, Rablin Sheree, Arnold Daniel, Connor Ann, Goyal Vikas, Stoney Tanya, Perrett Kirsten, Grimwood Keith
a Centre for Children's Health Research, Institute of Health & Biomedical Innovation, Queensland University of Technology , South Brisbane , Queensland , Australia.
b Child Health Division, Menzies School of Health Research, Charles Darwin University , Tiwi , Northern Territory , Australia.
Hum Vaccin Immunother. 2018;14(11):2768-2779. doi: 10.1080/21645515.2018.1488562. Epub 2018 Jul 12.
We aimed to determine the efficacy of the 10-valent pneumococcal- protein D conjugate vaccine (PHiD-CV) in children aged 18-months to <18-years with recurrent protracted bacterial bronchitis (rPBB), chronic suppurative lung disease (CSLD) or bronchiectasis. In a multi-centre, double-blind randomised controlled trial, children received two doses, 2-months apart of the 10vPHiD-CV or quadrivalent meningococcal-ACYW conjugate vaccine. Active surveillance for acute exacerbations, respiratory symptoms and antibiotic use was undertaken through to 12-months after the second vaccine dose (clinical cohort only). Serum, saliva and nasopharyngeal swabs were collected to measure immunological and microbiological effects (immunology cohort). Between December 2012 and August 2015, 62 children were enrolled onto the clinical protocol (1 excluded from clinical analyses due to unblinding), while 74 contributed to the immunology cohort (overall mean age = 6.8-years (standard deviation = 3.7), 42 (56.8%) male). The absolute risk difference comparing the 10vPHiD-CV group (n = 31 children) to the MenACYW group (n = 30 children) for acute exacerbations was -0.5 exacerbations/100-weeks at risk (95% confidence interval (CI) -2.0, 0.9). Compared to the MenACYW group, children who received the 10vPHiD-CV were less likely to have respiratory symptoms in each fortnight of surveillance (incidence density ratio (IDR) 0.82, 95%CI 0.61, 1.10) and required fewer short-course (<14-days duration) antibiotics (IDR 0.81, 95% CI 0.61, 1.09). The vaccine was immunogenic and no serious adverse events related to the vaccine were reported. In conclusion, 10vPHiD-CV might have a future role in managing children with rPBB, CSLD and bronchiectasis, but larger multicentre trials are needed to confirm or refute findings from this preliminary study.
我们旨在确定10价肺炎球菌-蛋白D结合疫苗（PHiD-CV）在18个月至未满18岁患有复发性迁延性细菌性支气管炎（rPBB）、慢性化脓性肺病（CSLD）或支气管扩张症的儿童中的疗效。在一项多中心、双盲随机对照试验中，儿童接受两剂疫苗，间隔2个月，分别接种10vPHiD-CV或四价脑膜炎球菌-ACYW结合疫苗。在第二剂疫苗接种后至12个月期间，对急性加重、呼吸道症状和抗生素使用情况进行主动监测（仅针对临床队列）。收集血清、唾液和鼻咽拭子以测量免疫和微生物学效应（免疫学子队列）。在2012年12月至2015年8月期间，62名儿童纳入临床方案（1名因破盲被排除在临床分析之外），74名儿童纳入免疫学子队列（总体平均年龄 = 6.8岁（标准差 = 3.7），42名（56.8%）为男性）。比较10vPHiD-CV组（31名儿童）和MenACYW组（30名儿童）急性加重的绝对风险差异为-0.5次加重/100周风险（95%置信区间（CI）-2.0，0.9）。与MenACYW组相比，接受10vPHiD-CV的儿童在每次两周监测期间出现呼吸道症状的可能性较小（发病密度比（IDR）0.82，95%CI 0.61，1.10），且需要的短疗程（<14天）抗生素较少（IDR 0.81，95%CI 0.61，1.09）。该疫苗具有免疫原性，未报告与疫苗相关的严重不良事件。总之，10vPHiD-CV在治疗rPBB、CSLD和支气管扩张症儿童方面可能具有未来作用，但需要更大规模的多中心试验来证实或反驳这项初步研究的结果。
