Effects of antigen dose and immunization regimens on antibody responses to a cytomegalovirus glycoprotein B subunit vaccine

Effects of antigen dose and immunization regimens on antibody responses to a cytomegalovirus glycoprotein B subunit vaccine
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DOI:
10.1086/315060
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发表时间:
1999-11-01
影响因子:
6.4
通讯作者:
Duliège, AM
Duliège, AM
中科院分区:
医学2区
文献类型:
--
作者:
Frey, SE;Harrison, C;Duliège, AM

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本I期研究的目的是评价2剂巨细胞病毒糖蛋白B(CMV gB)/MF 59疫苗在3种不同免疫接种时间表下的安全性和免疫原性。95名志愿者被随机分为6组。gB抗体代表CMV特异性中和应答的大部分。三组接受5 μ g gB抗原与MF 59的组合(一种专利佐剂),3组分别在0、1和2个月; 0、1和4个月;疫苗耐受性良好,两种剂量之间的抗体产生没有显著差异。当以0,1和6个月给药时,疫苗诱导最高抗体滴度,1,6个月。低剂量的CMV gB/MF 59可能是未来研究的首选剂量。
The purpose of this phase I study was to evaluate the safety and immunogenicity of 2 doses of cytomegalovirus glycoprotein B (CMV gB)/MF59 vaccine at 3 different immunization schedules. Ninety-five volunteers were randomized to 6 groups. Antibodies to gB represent the majority of the CMV-specific neutralizing response. Three groups received 5 mu g of gB antigen combined with MF59 (a proprietary adjuvant) and 3 groups received a 30-mu g dose at 0, 1, and 2 months; 0, 1, and 4 months; or 0, 1, and 6 months,The vaccine was well tolerated, and there was no significant difference in antibody production between the 2 doses, The vaccine induced highest antibody titers when given at 0, 1, and 6 months. A low dose of CMV gB/ MF59 may be the preferred dose for future studies.