An open-label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults.
An open-label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults.
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DOI：
10.1111/j.1750-2659.2012.00350.x
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发表时间：
2013-01
影响因子：
4.4
通讯作者：
Subbarao K
中科院分区：
文献类型：
--
作者：
Talaat KR;Karron RA;Liang PH;McMahon BA;Luke CJ;Thumar B;Chen GL;Min JY;Lamirande EW;Jin H;Coelingh KL;Kemble GW;Subbarao K
请引用本文：Talaat 等人。 (2012) 在健康成人中进行 H2N2 流感减毒活疫苗的开放标签 I 期试验。流感和其他呼吸道病毒 DOI：10.1111/j.1750‐2659.2012.00350.x。 背景 针对多种具有大流行潜力的毒株的减毒流感活疫苗（LAIV）正在开发和测试中。我们描述了 H2N2 减毒活疫苗的开放标签 I 期试验的结果。 目标 评估 H2N2 流感病毒减毒活疫苗的安全性、传染性和免疫原性。 参与者/方法 本研究中使用的 A/Ann Arbor/6/60 (H2N2) 病毒是减毒、冷适应、温度敏感毒株，提供季节性 LAIV (MedImmune) 的遗传骨架。我们评估了两剂 107 TCID50 疫苗通过鼻喷雾给药给正常健康血清阴性成人的安全性、传染性和免疫原性，间隔 4 周。 结果 21 名参与者接受了第一剂疫苗； 18 名参与者接受了第二剂疫苗。试验期间没有发生严重不良事件。疫苗接种后最常见的不良事件是头痛和肌肉骨骼疼痛。该疫苗的复制受到限制：在第一剂和第二剂后，分别有 24% 和 17% 的病毒可通过培养或 rRT-PCR 检测到。对疫苗的抗体反应也受到限制：24% 的参与者在注射一剂或两剂后出现抗体反应，通过血凝抑制测定 (10%) 或 ELISA 检测 H2 HA 特异性血清 IgG (24%) 或 IgA (16%)。没有一个参与者出现中和抗体反应。通过酶联免疫斑点测定，疫苗特异性 IgG 分泌细胞从平均 0·5 增加到 2·0/106 个外周血单核细胞 (PBMC)；疫苗特异性 IgA 分泌细胞从 0·1 PBMC 增加到 0·5/106。 结论 H2N2 1960 AA ca 减毒活疫苗表现出与季节性三价 LAIV 一致的安全性，但在健康血清阴性成人中复制受到限制且免疫原性极低。
Please cite this paper as: Talaat et al. (2012) An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2012.00350.x. Background Live attenuated influenza vaccines (LAIV) against a variety of strains of pandemic potential are being developed and tested. We describe the results of an open‐label phase I trial of a live attenuated H2N2 virus vaccine. Objectives To evaluate the safety, infectivity, and immunogenicity of a live attenuated H2N2 influenza virus vaccine. Participants/methods The A/Ann Arbor/6/60 (H2N2) virus used in this study is the attenuated, cold‐adapted, temperature‐sensitive strain that provides the genetic backbone of seasonal LAIV (MedImmune). We evaluated the safety, infectivity, and immunogenicity of two doses of 107 TCID50 of this vaccine administered by nasal spray 4 weeks apart to normal healthy seronegative adults. Results Twenty‐one participants received a first dose of the vaccine; 18 participants received a second dose. No serious adverse events occurred during the trial. The most common adverse events after vaccination were headache and musculoskeletal pain. The vaccine was restricted in replication: 24% and 17% had virus detectable by culture or rRT‐PCR after the first and second dose, respectively. Antibody responses to the vaccine were also restricted: 24% of participants developed an antibody response as measured by either hemagglutination‐inhibition assay (10%), or ELISA for H2 HA‐specific serum IgG (24%) or IgA (16%) after either one or two doses. None of the participants had a neutralizing antibody response. Vaccine‐specific IgG‐secreting cells as measured by enzyme‐linked immunospot increased from a mean of 0·5 to 2·0/106 peripheral blood mononuclear cells (PBMCs); vaccine‐specific IgA‐secreting cells increased from 0·1 to 0·5/106 PBMCs. Conclusions The live attenuated H2N2 1960 AA ca vaccine demonstrated a safety profile consistent with seasonal trivalent LAIV but was restricted in replication and minimally immunogenic in healthy seronegative adults.
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