Institute of Experimental Medicine, Department of Virology, St Petersburg, Russia.
Vaccine. 2011 Jul 1;29 Suppl 1:A40-4. doi: 10.1016/j.vaccine.2011.04.122.
In February 2009, Nobilon granted the World Health Organization (WHO) a non-exclusive licence to develop, register, manufacture, use and sell seasonal a pandemic live attenuated influenza vaccine (LAIV) produced on embryonated chicken eggs. WHO was permitted to grant sub-licences to vaccine manufacturers in developing countries within the framework of its influenza vaccine technology transfer initiative. In parallel, the Institute of Experimental Medicine (IEM), Russia, concluded an agreement with WHO for the supply of Russian LAIV reassortants for use by these manufacturers. Also in 2009, IEM carried out a study on a novel A/17/California/2009/38 (H1N1) pandemic LAIV candidate derived from the pandemic-related A/California/07/2009 (H1N1) influenza virus and the attenuated A/Leningrad/134/17/57 (H2N2) master donor virus, using routine reassortant technique in embryonated chicken eggs. Following successful preclinical studies in eggs and in ferrets, a double-blind, controlled, randomized clinical trial was carried out in immunologically naïve study participants between 12-18 and 18-60 years old. Collectively, the immunogenicity data (haemagglutinin inhibition test, ELISA and cytokine tests for the detection of memory T cells) support the use of a single dose of the pandemic H1N1 LAIV in 12-60 year olds. The outcome of the studies showed no significant adverse reactions attributable to the vaccine, and suggests that the vaccine is as safe and immunogenic as seasonal influenza vaccines. Importantly, it was clearly demonstrated that reliance on the HAI assay alone is not recommended for testing LAIV. To date, via the licence agreement with WHO, the H1N1 LAIV has been transferred to the Government Pharmaceutical Organization in Thailand, the Serum Institute of India, and the Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. in China.
2009 年 2 月，挪比昂向世界卫生组织（WHO）授予了一项非独占许可，以开发、注册、制造、使用和销售在鸡胚上生产的季节性大流行性流感减毒活疫苗（LAIV）。WHO 被允许在其流感疫苗技术转让倡议框架内向发展中国家的疫苗制造商授予分许可。与此同时，俄罗斯实验医学研究所（IEM）与世界卫生组织达成协议，供应这些制造商使用的俄罗斯 LAIV 重配体。同样在 2009 年，IEM 使用常规的鸡胚重组技术，对源自与大流行相关的 A/加利福尼亚/07/2009（H1N1）流感病毒和减毒的 A/列宁格勒/134/17/57（H2N2）主供体病毒的新型 A/17/加利福尼亚/2009/38（H1N1）大流行 LAIV 候选物进行了研究。在鸡蛋和雪貂中成功进行了临床前研究后，在免疫原性未受影响的研究参与者中进行了一项双盲、对照、随机临床试验，参与者年龄在 12-18 岁和 18-60 岁之间。总的来说，免疫原性数据（血凝抑制试验、ELISA 和用于检测记忆 T 细胞的细胞因子试验）支持在 12-60 岁人群中使用一剂大流行 H1N1 LAIV。研究结果表明，疫苗没有明显的不良反应，表明该疫苗与季节性流感疫苗一样安全且具有免疫原性。重要的是，清楚地表明，仅依赖血凝抑制测定法不建议用于 LAIV 的检测。迄今为止，通过与世界卫生组织的许可协议，已将 H1N1 LAIV 转让给泰国政府制药组织、印度血清研究所和中国浙江天元生物制药有限公司。
