H2N2V1, Main, Exploration, bibRecord, 000D62

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 : 000D62 ( Main/Exploration ); précédent : 000D61; suivant : 000D63

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

Auteurs : Larisa Rudenko [Russie, Australie] ; Han Van Den Bosch [Pays-Bas] ; Irina Kiseleva [Russie, Australie] ; Alexander Mironov [Russie] ; Anatoly Naikhin [Russie] ; Natalie Larionova [Russie] ; Dimitry Bushmenkov [Russie]

Source :

Vaccine. Supplement [ 1359-5938 ] ; 2011.

RBID : Pascal:11-0359827

Descripteurs français

Pascal (Inist)
- Souche atténuée, Vaccin, Californie, Pays en développement, Grippe A, Virus grippal A(H1N1).
Wicri :
- topic : Vaccin, Pays en développement.

English descriptors

KwdEn :
- Attenuated strain, California, Developing countries, Influenza A, Influenzavirus A(H1N1), Vaccine.

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 naive 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.

Affiliations:

Links toward previous steps (curation, corpus...)

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to stream PascalFrancis, to step Checkpoint: 000012
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Le document en format XML

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<author><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name>
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<author><name sortKey="Larionova, Natalie" sort="Larionova, Natalie" uniqKey="Larionova N" first="Natalie" last="Larionova">Natalie Larionova</name>
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<s2>St Petersburg</s2>
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<wicri:noRegion>St Petersburg</wicri:noRegion>
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</author>
<author><name sortKey="Bushmenkov, Dimitry" sort="Bushmenkov, Dimitry" uniqKey="Bushmenkov D" first="Dimitry" last="Bushmenkov">Dimitry Bushmenkov</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Microgen Federal State Company</s1>
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<country>Russie</country>
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<publicationStmt><idno type="wicri:source">INIST</idno>
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<date when="2011">2011</date>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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</title>
<author><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name>
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<s2>St Petersburg</s2>
<s3>RUS</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
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<wicri:noRegion>St Petersburg</wicri:noRegion>
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<author><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>
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<author><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</name>
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<s3>RUS</s3>
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<wicri:noRegion>St Petersburg</wicri:noRegion>
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<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>BioDiem Ltd.</s1>
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<sZ>1 aut.</sZ>
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<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mironov, Alexander" sort="Mironov, Alexander" uniqKey="Mironov A" first="Alexander" last="Mironov">Alexander Mironov</name>
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<s3>RUS</s3>
<sZ>4 aut.</sZ>
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<placeName><settlement type="city">Moscou</settlement>
<region>District fédéral central</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Naikhin, Anatoly" sort="Naikhin, Anatoly" uniqKey="Naikhin A" first="Anatoly" last="Naikhin">Anatoly Naikhin</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute of Experimental Medicine, Department of Virology</s1>
<s2>St Petersburg</s2>
<s3>RUS</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Russie</country>
<wicri:noRegion>St Petersburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Larionova, Natalie" sort="Larionova, Natalie" uniqKey="Larionova N" first="Natalie" last="Larionova">Natalie Larionova</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute of Experimental Medicine, Department of Virology</s1>
<s2>St Petersburg</s2>
<s3>RUS</s3>
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<sZ>3 aut.</sZ>
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<country>Russie</country>
<wicri:noRegion>St Petersburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bushmenkov, Dimitry" sort="Bushmenkov, Dimitry" uniqKey="Bushmenkov D" first="Dimitry" last="Bushmenkov">Dimitry Bushmenkov</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Microgen Federal State Company</s1>
<s2>Moscow</s2>
<s3>RUS</s3>
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<placeName><settlement type="city">Moscou</settlement>
<region>District fédéral central</region>
</placeName>
</affiliation>
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<series><title level="j" type="main">Vaccine. Supplement</title>
<title level="j" type="abbreviated">Vaccine., Suppl.</title>
<idno type="ISSN">1359-5938</idno>
<imprint><date when="2011">2011</date>
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</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Attenuated strain</term>
<term>California</term>
<term>Developing countries</term>
<term>Influenza A</term>
<term>Influenzavirus A(H1N1)</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Souche atténuée</term>
<term>Vaccin</term>
<term>Californie</term>
<term>Pays en développement</term>
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<term>Virus grippal A(H1N1)</term>
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<front><div type="abstract" xml:lang="en">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 naive 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>Australie</li>
<li>Pays-Bas</li>
<li>Russie</li>
</country>
<region><li>District fédéral central</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Melbourne</li>
<li>Moscou</li>
</settlement>
</list>
<tree><country name="Russie"><noRegion><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name>
</noRegion>
<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>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Rudenko, Larisa" sort="Rudenko, Larisa" uniqKey="Rudenko L" first="Larisa" last="Rudenko">Larisa Rudenko</name>
</region>
<name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</name>
</country>
<country name="Pays-Bas"><noRegion><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>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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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

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

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri