Safety and immunogenicity of a recombinant hemagglutinin vaccine for H5 influenza in humans
Safety and immunogenicity of a recombinant hemagglutinin vaccine for H5 influenza in humans
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DOI：
10.1016/s0264-410x(00)00395-9
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发表时间：
2001-02-08
期刊：
影响因子：
5.5
通讯作者：
Katz, JM
中科院分区：
文献类型：
--
作者：
Treanor, JJ;Wilkinson, BE;Katz, JM
最近人类爆发的禽流感表明需要针对具有大流行潜力的流感病毒疫苗。重组血凝素是此类疫苗的一个有吸引力的选择，因为它们不需要处理潜在的高致病性流感病毒来生产疫苗。为了评估重组杆状病毒表达的 H5 HA (rH5) 在人体中的免疫原性、最佳剂量和给药时间，147 名健康成年人被随机分配接受肌内注射 rH5，剂量分别为 25、45 或 90 微克，一剂 90 微克，随后一剂 10 微克，或两剂安慰剂，剂量之间的间隔为 21、18 或 10 微克。 42天。所有剂量的 rH5 均具有良好的耐受性。 rH5 疫苗在高剂量下具有适度的免疫原性。单次服用 90 杯后，23% (14/60) 的个体出现滴度为 1:80 或更高的中和抗体反应，两次服用 90 杯后，这一比例为 52% (15/29)。 21 至 42 天的不同剂量间隔对抗体对疫苗接种的反应没有显着影响。这些结果表明，杆状病毒表达的H5 HA可以在先前未接触过H5病毒的个体中诱导功能性抗体，但需要进一步研究以提高疫苗的免疫原性。 (C) 2001 Elsevier Science Ltd. 保留所有权利。
Recent outbreaks of avian influenza in humans have demonstrated the need for vaccines for influenza viruses with pandemic potential. Recombinant hemagglutinins are an attractive option for such vaccines because they do not require handling potentially highly pathogenic influenza viruses for vaccine production. In order to evaluate the immunogenicity, optimum dosing and timing of administration of a recombinant baculovirus-expressed H5 HA (rH5) in humans, 147 healthy adults were assigned randomly to receive intramuscular rH5 as two doses of 25, 45 or 90 mug each, one dose of 90 mug followed by a dose of 10 mug, or two doses of placebo, at intervals between doses of 21, 18 or 42 days. All doses of rH5 were well tolerated. The rH5 vaccine was modestly immunogenic at high dose. Neutralizing antibody responses to a titer of 1:80 or greater were seen in 23% (14/60) of individuals after a single dose of 90 mug, and in 52% (15/29) after two doses of 90 mug. Varying intervals between doses from 21 to 42 days had no significant effect on antibody responses to vaccination. These results suggest that baculovirus-expressed H5 HA can induce functional antibody in individuals who have not had prior exposure to H5 viruses, but that further studies to improve the immunogenicity of the vaccine are needed. (C) 2001 Elsevier Science Ltd. All rights reserved.