Live attenuated pandemic influenza vaccine: clinical studies on A/17/California/2009/38 (H1N1) and licensing of the Russian-developed technology to WHO for pandemic influenza preparedness in developing countries.

摘要: In February 2009, Nobilon granted the World Health Organization (WHO) a non-exclusive licence to develop, register, manufacture, use and sell seasonal pandemic live attenuated influenza vaccine (LAIV) produced on embryonated chicken eggs. WHO was permitted grant sub-licences manufacturers in developing countries within framework of its technology transfer initiative. parallel, Institute Experimental Medicine (IEM), Russia, concluded an agreement with for supply Russian LAIV reassortants by these manufacturers. Also IEM carried out study novel A/17/California/2009/38 (H1N1) candidate derived from pandemic-related A/California/07/2009 virus A/Leningrad/134/17/57 (H2N2) master donor virus, using routine reassortant technique Following successful preclinical studies eggs ferrets, double-blind, controlled, randomized clinical trial immunologically naive participants between 12-18 18-60 years old. Collectively, immunogenicity data (haemagglutinin inhibition test, ELISA cytokine tests detection memory T cells) support single dose H1N1 12-60 year olds. The outcome showed no significant adverse reactions attributable vaccine, suggests that is as safe immunogenic vaccines. Importantly, it clearly demonstrated reliance HAI assay alone not recommended testing LAIV. To date, via WHO, has been transferred Government Pharmaceutical Thailand, Serum India, Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. China.