Purified fusion protein vaccine protects against lower respiratory tract illness during respiratory syncytial virus season in children with cystic fibrosis
Purified fusion protein vaccine protects against lower respiratory tract illness during respiratory syncytial virus season in children with cystic fibrosis
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DOI：
10.1097/00006454-199601000-00006
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发表时间：
1996-01-01
影响因子：
3.6
通讯作者：
Hiatt, PW
中科院分区：
文献类型：
--
作者：
Piedra, PA;Grace, S;Hiatt, PW
Objective.在一项双盲、安慰剂对照研究中，在患有囊性纤维化（CF）的呼吸道合胞病毒（RSV）血清阳性儿童中测试抗RSV的纯化融合蛋白（PFP-2）疫苗。17名CF儿童（平均年龄4.5岁）接受PFP-2疫苗接种，17名CF儿童（平均年龄5.8岁）接受盐水疫苗接种。在入组时记录Shwachman临床评分、Brasfield放射学评分、血氧饱和度（SpO（2））、人体测量指标和其他变量。接种后每天评估反应，持续7天。在RSV季节期间，每周进行一次电话访谈，并对患有急性呼吸道疾病的儿童进行评估和RSV培养，在接种疫苗前、接种疫苗后1个月和RSV季节结束时抽取血清，并检测RSV抗体。除年龄外，入组时的基线测量值在组间相似，PFP-2疫苗产生轻度局部反应，并在三分之二的疫苗接种者中诱导显著的中和抗体应答，在几乎所有PFP-2疫苗接种者中诱导显著的酶联免疫吸附测定-融合糖蛋白抗体应答，在感染RSV的PFP-2疫苗接种者中未观察到疫苗增强疾病，未观察到对RSV感染的保护;然而，在RSV感染的PFP-2疫苗组中，下呼吸道疾病的平均数量（0.8 vs，2.1）、抗生素疗程（2.2 vs，4.5）和患病天数（30.5 vs，67）显著减少（t检验，P < 0.01）。在RSV血清阳性CF儿童中显示了PFP-2疫苗在RSV季节对下呼吸道疾病的有效性。
Objective. To test in a double blind, placebo-controlled study a purified fusion protein (PFP-2) vaccine against respiratory syncytial virus (RSV) in RSV-seropositive children with cystic fibrosis (CF).Methods. Seventeen CF children, mean age 4.5 years, received PFP-2 vaccine and 17 CF children, mean age 5.8 years, received a saline vaccine, At enrollment the Shwachman clinical score, Brasfield radiographic score, oxygen saturation (SpO(2)), anthropometric indices and other variables were recorded, After vaccination the reactions were assessed daily for 7 days, During the RSV season weekly telephone interviews were performed and children with an acute respiratory illness were evaluated and cultured for RSV, Serum was drawn before vaccination, 1 month after vaccination and at the end of the RSV season and tested for antibodies to RSV.Results. Other than age the baseline measurements at enrollment were similar between groups, The PFP-2 vaccine produced mild local reactions and induced a significant neutralizing antibody response in two-thirds of the vaccinees and a significant enzyme-linked immunosorbent assay-fusion glycoprotein antibody response in nearly all the PFP-2 vaccinees, Vaccine-enhanced disease was not observed in PFP-2 vaccinees infected with RSV, Protection against RSV infection was not observed; however, a significant reduction (t test, P < 0.01) in mean number of lower respiratory tract illnesses (0.8 vs, 2.1), antibiotic courses (2.2 vs 4.5) and days ill (30.5 vs, 67) occurred among RSV-infected PFP-2 vaccinees.Conclusions. Efficacy of the PFP-2 vaccine against lower respiratory tract illness during the RSV season was shown in RSV-seropositive children with CF.