Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine
Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine
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DOI：
10.1056/nejmoa055778
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发表时间：
2006-03-30
影响因子：
158.5
通讯作者：
Wolff, M
中科院分区：
文献类型：
--
作者：
Treanor, JJ;Campbell, JD;Wolff, M
背景：甲型流感（H5N1）病毒可能导致严重的全球性流行病，具有高发病率，大量死亡和住院，以及广泛的破坏。针对这些病毒的有效疫苗在humans are immediately needed.METHODS：我们进行了一项多中心，双盲两阶段的研究，涉及451名健康成人18至64岁的人被随机分配在2：2：2：2：1的比例接受两个肌肉注射剂量的亚病毒体流感A（H5N1）疫苗的90，45，15，或7.5微克的血凝素抗原或安慰剂。对受试者进行了56天的安全性分析随访。每次接种前和第二次接种后28天获得的血清样品进行了测试H5抗体的微量中和和hemagglutininationinhibition.RESULTS：在注射部位的轻微疼痛是所有剂量的疫苗最常见的不良事件。在接受45微克或90微克剂量的受试者中，血清抗体应答的频率最高。在接受两次90微克剂量的患者中，54%的中和抗体滴度达到1：40或更高，58%的血凝抑制滴度达到1：40或更高。在接受45、15和7.5 μ g两种剂量的受试者中，分别有43%、22%和9%的受试者的中和滴度为1：40或更高。安慰剂recipients.CONCLUSIONS：90微克的亚病毒体A型流感（H5N1）疫苗的两剂方案不会引起严重的副作用，并在大多数收件人，产生中和抗体反应通常与保护免受流感。常规亚病毒粒子H5流感疫苗可有效预防人类甲型流感（H5N1）疾病。
BACKGROUND:Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed.METHODS:We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 microg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition.RESULTS:Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 microg or 90 microg. Among those who received two doses of 90 microg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 microg, respectively. No responses were seen in placebo recipients.CONCLUSIONS:A two-dose regimen of 90 microg of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans.