Trial of 2009 Influenza A (H1N1) Monovalent MF59-Adjuvanted Vaccine.
Trial of 2009 Influenza A (H1N1) Monovalent MF59-Adjuvanted Vaccine.
复制标题
DOI：
10.1056/nejmoa0907650
复制
发表时间：
2009-12-17
影响因子：
158.5
通讯作者：
Stephenson, Iain
中科院分区：
文献类型：
--
作者：
Clark, Tristan W.;Pareek, Manish;Stephenson, Iain
背景：2009 年大流行的甲型 H1N1 流感病毒的出现引发了 21 世纪的第一次大流行。开发有效的疫苗是公共卫生的首要任务。 方法：我们进行了一项单中心研究，涉及 176 名 18 至 50 岁的成年人，以测试单价甲型流感/加利福尼亚/2009 (H1N1) 表面抗原疫苗，包括 MF59 佐剂和非佐剂形式。受试者被随机分配在第 0 天每只手臂接受两次含有 7.5 微克血凝素的疫苗肌肉注射，或在第 0 天注射一次，在第 7、14 或 21 天注射另一次；或两次 3.75 微克剂量的 MF59 佐剂疫苗，或 7.5 或 15 微克无佐剂疫苗，间隔 21 天施用。注射第一剂后第 0、14、21 和 42 天通过血凝抑制试验和微量中和试验测量抗体反应。 结果：最常见的局部和全身反应是注射部位疼痛和肌肉酸痛，分别有 70% 和 42% 的受试者出现； MF59 佐剂疫苗的反应比非佐剂疫苗更常见。服用任一剂量后，三名受试者报告发烧，体温达到 38 摄氏度或更高。在第 21 天，接受一剂 MF59 佐剂疫苗的受试者的抗体滴度（以几何平均值表示）高于接受一剂非佐剂疫苗的受试者（P
Background: The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.Methods: We conducted a single-center study, involving 176 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 microg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-microg doses of MF59-adjuvanted vaccine, or 7.5 or 15 microg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.Results: The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively; reactions were more common with the MF59-adjuvanted vaccine than with nonadjuvanted vaccine. Three subjects reported fever, with a temperature of 38 degreesC or higher, after either dose. Antibody titers, expressed as geometric means, were higher at day 21 among subjects who had received one dose of MF59-adjuvanted vaccine than among those who had received one dose of nonadjuvanted vaccine (P