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.
Identifieur interne : 000C38 ( Main/Exploration ); précédent : 000C37; suivant : 000C39Live 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.
Auteurs : Larisa Rudenko [Russie] ; Han Van Den Bosch ; Irina Kiseleva ; Alexander Mironov ; Anatoly Naikhin ; Natalie Larionova ; Dimitry BushmenkovSource :
- Vaccine [ 1873-2518 ] ; 2011.
Descripteurs français
- KwdFr :
- Autorisation d'exercer (législation et jurisprudence), Essais contrôlés randomisés comme sujet, Grippe humaine (), Humains, Organisation mondiale de la santé, Pays en voie de développement, Russie, Sous-type H1N1 du virus de la grippe A (immunologie), Technologie pharmaceutique (), Tranfert de technologie, Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins atténués (effets indésirables), Vaccins atténués (immunologie).
- MESH :
- effets indésirables : Vaccins antigrippaux, Vaccins atténués.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux, Vaccins atténués.
- législation et jurisprudence : Autorisation d'exercer.
- Essais contrôlés randomisés comme sujet, Grippe humaine, Humains, Organisation mondiale de la santé, Pays en voie de développement, Russie, Technologie pharmaceutique, Tranfert de technologie.
English descriptors
- KwdEn :
- Developing Countries, Humans, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Licensure (legislation & jurisprudence), Randomized Controlled Trials as Topic, Russia, Technology Transfer, Technology, Pharmaceutical (methods), Vaccines, Attenuated (adverse effects), Vaccines, Attenuated (immunology), World Health Organization.
- MESH :
- chemical , adverse effects : Influenza Vaccines, Vaccines, Attenuated.
- chemical , immunology : Vaccines, Attenuated.
- geographic : Russia.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- legislation & jurisprudence : Licensure.
- methods : Technology, Pharmaceutical.
- prevention & control : Influenza, Human.
- Developing Countries, Humans, Randomized Controlled Trials as Topic, Technology Transfer, World Health Organization.
Abstract
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.
DOI: 10.1016/j.vaccine.2011.04.122
PubMed: 21684428
Affiliations:
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Le document en format XML
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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.</div></front></TEI><affiliations><list><country><li>Russie</li></country></list><tree><noCountry><name sortKey="Bushmenkov, Dimitry" sort="Bushmenkov, Dimitry" uniqKey="Bushmenkov D" first="Dimitry" last="Bushmenkov">Dimitry Bushmenkov</name><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</name><name sortKey="Larionova, Natalie" sort="Larionova, Natalie" uniqKey="Larionova N" first="Natalie" last="Larionova">Natalie Larionova</name><name sortKey="Mironov, Alexander" sort="Mironov, Alexander" uniqKey="Mironov A" first="Alexander" last="Mironov">Alexander Mironov</name><name sortKey="Naikhin, Anatoly" sort="Naikhin, Anatoly" uniqKey="Naikhin A" first="Anatoly" last="Naikhin">Anatoly Naikhin</name><name sortKey="Van Den Bosch, Han" sort="Van Den Bosch, Han" uniqKey="Van Den Bosch H" first="Han" last="Van Den Bosch">Han Van Den Bosch</name></noCountry><country name="Russie"><noRegion><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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