Bihari Iván, Pánczél Gyula, Kovacs Jozsef, Beygo Jenny, Fragapane Elena
Pestszentlőrinc-Pestszentimre Health Service KFT, Budapest, Hungary.
Clin Vaccine Immunol. 2012 Dec;19(12):1943-8. doi: 10.1128/CVI.00373-12. Epub 2012 Oct 17.
Preparedness against an A/H5N1 influenza pandemic requires well-tolerated, effective vaccines which provide both vaccine strain-specific and heterologous, cross-clade protection. This study was conducted to assess the immunogenicity and safety profile of an MF59-adjuvanted, prepandemic influenza vaccine containing A/turkey/Turkey/01/2005 (H5N1) strain viral antigen. A total of 343 participants, 194 adults (18 to 60 years) and 149 elderly individuals (≥61 years), received two doses of the investigational vaccine given 3 weeks apart. Homologous and heterologous antibody responses were analyzed by hemagglutination inhibition (HI), single radial hemolysis (SRH), and microneutralization (MN) assays 3 weeks after administration of the first vaccine dose and 3 weeks and 6 months after the second dose. Immunogenicity was assessed according to European licensure criteria for pandemic influenza vaccines. After two vaccine doses, all three European licensure criteria were met for adult and elderly subjects against the homologous vaccine strain, A/turkey/Turkey/1/2005, when analyzed by HI and SRH assays. Cross-reactive antibody responses were observed by HI and SRH analyses against the heterologous H5N1 strains, A/Indonesia/5/2005 and A/Vietnam/1194/2004, in adult and elderly subjects. Solicited local and systemic reactions were mostly mild to moderate in severity and occurred less frequently in the elderly than in adult vaccinees. In both adult and elderly subjects, MF59-adjuvanted vaccine containing 7.5 μg of A/Turkey strain influenza virus antigen was highly immunogenic, well tolerated, and able to elicit cross-clade, heterologous antibody responses against A/Indonesia and A/Vietnam strains 6 weeks after the first vaccination.
防范甲型H5N1流感大流行需要耐受性良好、有效的疫苗，这些疫苗既要提供针对疫苗株的特异性保护，也要提供异源的、跨谱系的保护。本研究旨在评估一种含A/火鸡/土耳其/01/2005（H5N1）株病毒抗原、添加MF59佐剂的大流行前流感疫苗的免疫原性和安全性。共有343名参与者，其中194名成年人（18至60岁）和149名老年人（≥61岁），相隔3周接种两剂研究用疫苗。在接种第一剂疫苗3周后、第二剂疫苗3周和6个月后，通过血凝抑制（HI）、单向辐射溶血（SRH）和微量中和（MN）试验分析同源和异源抗体反应。根据欧洲大流行流感疫苗的许可标准评估免疫原性。接种两剂疫苗后，通过HI和SRH试验分析，成年和老年受试者针对同源疫苗株A/火鸡/土耳其/1/2005均符合所有三项欧洲许可标准。在成年和老年受试者中，通过HI和SRH分析观察到针对异源H5N1毒株A/印度尼西亚/5/2005和A/越南/1194/2004的交叉反应抗体反应。预期的局部和全身反应大多为轻度至中度，且在老年人中发生的频率低于成年疫苗接种者。在成年和老年受试者中，含7.5μg A/土耳其株流感病毒抗原、添加MF59佐剂的疫苗具有高度免疫原性，耐受性良好，并且在首次接种后6周能够引发针对A/印度尼西亚和A/越南毒株的跨谱系、异源抗体反应。
