Safety and immunogenicity of a respiratory syncytial virus subunit vaccine (PFP 2) in ambulatory adults over age 60

Safety and immunogenicity of a respiratory syncytial virus subunit vaccine (PFP 2) in ambulatory adults over age 60
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DOI:
10.1016/s0264-410x(96)00030-8
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发表时间:
1996-09-01
期刊:
影响因子:
5.5
通讯作者:
Walsh, EE
Walsh, EE
中科院分区:
医学3区
文献类型:
--
作者:
Falsey, AR;Walsh, EE

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在一项随机、安慰剂对照、双盲研究中评价了纯化融合蛋白(PFP-2)呼吸道合胞病毒(RSV)疫苗的安全性和免疫原性,该研究纳入了64名60岁以上的健康成人。接种耐受性良好,无明显急性副作用。在接种后8周,33名接种者中有29名(87%)显示RSV F蛋白的血清IgG升高大于或等于4倍。33名疫苗接种者中有20名(61%)的血清A组和/或B组RSV中和滴度升高≥ 4倍。对疫苗接种的反应与免疫前血清中和滴度呈负相关。整个冬季的积极监测发现安慰剂组有3例RSV感染,而疫苗组没有。因此,发现PFP-2在健康老年人中是安全和免疫原性的。版权所有(C)1996爱思唯尔科学有限公司
The safety and immunogenicity of purified fusion protein (PFP-2) respiratory syncytial virus (RSV) vaccine was evaluated in a randomized placebo-controlled, double-blind study of 64 healthy adults over age 60. Vaccination was well tolerated with no significant acute side-effects. Twenty-nine of 33 vaccinees (87%) showed a greater than or equal to fourfold rise in serum IgG to the F protein of RSV at 8 weeks post vaccination. Twenty of 33 vaccine recipients (61%) had a greater than or equal to fourfold rise in serum neutralizing titer to group A and/or group B RSV. Response to vaccination was inversely correlated with pre-immunization serum neutralizing titers. Active surveillance throughout the ensuing winter identified three RSV infections in the placebo group and none in the vaccine group. Thus, PFP-2 was found to be safe and immunogenic in healthy older adults. Copyright (C) 1996 Elsevier Science Ltd.