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 : 000012 ( PascalFrancis/Checkpoint ); précédent : 000011; suivant : 000013Live 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.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Vaccin, Pays en développement.
English descriptors
- KwdEn :
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.
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(État)</region></placeName></affiliation></author><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><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Nobilon International BV</s1><s2>Boxmeer</s2><s3>NLD</s3><sZ>2 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nobilon International BV</wicri:noRegion></affiliation></author><author><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</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><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>BioDiem Ltd.</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>1 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Rudenko</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><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>BioDiem Ltd.</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><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><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Nobilon International BV</s1><s2>Boxmeer</s2><s3>NLD</s3><sZ>2 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nobilon International BV</wicri:noRegion></affiliation></author><author><name sortKey="Kiseleva, Irina" sort="Kiseleva, Irina" uniqKey="Kiseleva I" first="Irina" last="Kiseleva">Irina Kiseleva</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><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>BioDiem Ltd.</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><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><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Microgen Federal State Company</s1><s2>Moscow</s2><s3>RUS</s3><sZ>4 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>Russie</country><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><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="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><sZ>4 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author></analytic><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></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Vaccine. Supplement</title><title level="j" type="abbreviated">Vaccine., Suppl.</title><idno type="ISSN">1359-5938</idno></seriesStmt></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><term>Grippe A</term><term>Virus grippal A(H1N1)</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term><term>Pays en développement</term></keywords></textClass></profileDesc></teiHeader><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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>1359-5938</s0></fA01><fA03 i2="1"><s0>Vaccine., Suppl.</s0></fA03><fA05><s2>29</s2></fA05><fA06><s2>1</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>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</s1></fA08><fA09 i1="01" i2="1" l="ENG"><s1>Transfer of Technology for Pandemic Influenza Vaccine Production in Developing Countries</s1></fA09><fA11 i1="01" i2="1"><s1>RUDENKO (Larisa)</s1></fA11><fA11 i1="02" i2="1"><s1>VAN DEN BOSCH (Han)</s1></fA11><fA11 i1="03" i2="1"><s1>KISELEVA (Irina)</s1></fA11><fA11 i1="04" i2="1"><s1>MIRONOV (Alexander)</s1></fA11><fA11 i1="05" i2="1"><s1>NAIKHIN (Anatoly)</s1></fA11><fA11 i1="06" i2="1"><s1>LARIONOVA (Natalie)</s1></fA11><fA11 i1="07" i2="1"><s1>BUSHMENKOV (Dimitry)</s1></fA11><fA12 i1="01" i2="1"><s1>SPIER (Ray)</s1><s9>ed.</s9></fA12><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></fA14><fA14 i1="02"><s1>BioDiem Ltd.</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></fA14><fA14 i1="03"><s1>Nobilon International BV</s1><s2>Boxmeer</s2><s3>NLD</s3><sZ>2 aut.</sZ></fA14><fA14 i1="04"><s1>Microgen Federal State Company</s1><s2>Moscow</s2><s3>RUS</s3><sZ>4 aut.</sZ><sZ>7 aut.</sZ></fA14><fA20><s2>A40-A44</s2></fA20><fA21><s1>2011</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20289S</s2><s5>354000189916470100</s5></fA43><fA44><s0>0000</s0><s1>© 2011 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>14 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>11-0359827</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Vaccine. Supplement</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002A05F04</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Souche atténuée</s0><s5>05</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Attenuated strain</s0><s5>05</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Cepa atenuada</s0><s5>05</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Vaccin</s0><s5>06</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Vaccine</s0><s5>06</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Vacuna</s0><s5>06</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Californie</s0><s2>NG</s2><s5>07</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>California</s0><s2>NG</s2><s5>07</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>California</s0><s2>NG</s2><s5>07</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Pays en développement</s0><s5>08</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Developing countries</s0><s5>08</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Países en desarrollo</s0><s5>08</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Grippe A</s0><s5>14</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Influenza A</s0><s5>14</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Gripe A</s0><s5>14</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Virus grippal A(H1N1)</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Influenzavirus A(H1N1)</s0><s4>CD</s4><s5>96</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Etats-Unis</s0><s2>NG</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>United States</s0><s2>NG</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Estados Unidos</s0><s2>NG</s2></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Amérique du Nord</s0><s2>NG</s2></fC07><fC07 i1="02" i2="X" l="ENG"><s0>North America</s0><s2>NG</s2></fC07><fC07 i1="02" i2="X" l="SPA"><s0>America del norte</s0><s2>NG</s2></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Amérique</s0><s2>NG</s2></fC07><fC07 i1="03" i2="X" l="ENG"><s0>America</s0><s2>NG</s2></fC07><fC07 i1="03" i2="X" l="SPA"><s0>America</s0><s2>NG</s2></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Virose</s0></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Viral disease</s0></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Virosis</s0></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Infection</s0></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Infection</s0></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Infección</s0></fC07><fN21><s1>249</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><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>Pour manipuler ce document sous Unix (Dilib)
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|texte= 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
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