Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza A/H5N1 Vaccine in Children
Identifieur interne : 000C77 ( Pmc/Curation ); précédent : 000C76; suivant : 000C78Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza A/H5N1 Vaccine in Children
Auteurs : Tawee Chotpitayasunondh [Thaïlande] ; Usa Thisyakorn [Thaïlande] ; Chitsanu Pancharoen [Thaïlande] ; Stephanie Pepin [France] ; Nolwenn Nougarede [France]Source :
- PLoS ONE [ 1932-6203 ] ; 2008.
Abstract
Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia, Africa and Europe. It has also infected people, especially children, causing severe illness and death. Although the virus shows limited ability to transmit between humans, A/H5N1 represents a potential source of the next influenza pandemic. This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted (Al) and non adjuvanted influenza A/Vietnam/1194/2004 NIBRG-14 (H5N1) vaccine in children.
In a Phase II, open, randomised, multicentre trial 180 children aged 6 months to 17 years received two injections, 21 days apart, of vaccine containing either: 30 µg haemagglutinin (HA) with adjuvant (30 µg+Al) or 7.5 µg HA without adjuvant. An additional 60 children aged 6–35 months received two “half dose” injections (ie 15 µg+Al or 3.8 µg). Safety was followed for 21 days after vaccination. Antibody responses were assessed 21 days after each injection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30 µg+Al formulation was more immunogenic than 7.5 µg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres ≥32 (1/dil). Among 6–35 month-olds, the full doses were more immunogenic than their half dose equivalents. Vaccination induced a predominantly Th2 response against H5 HA.
This influenza A(H5N1) vaccine was well tolerated and immunogenic in children and infants, with Al adjuvant providing a clear immunogenic advantage. These results demonstrate that an H5N1 Al-adjuvanted vaccine, previously shown to be immunogenic and safe in adults, can also be used in children, the group most at risk for pandemic influenza.
ClinicalTrials.gov
Url:
DOI: 10.1371/journal.pone.0004028
PubMed: 19112513
PubMed Central: 2605261
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xml:lang="fr">Thaïlande</country><wicri:regionArea>Chulalongkorn Hospital, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Pancharoen, Chitsanu" sort="Pancharoen, Chitsanu" uniqKey="Pancharoen C" first="Chitsanu" last="Pancharoen">Chitsanu Pancharoen</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Chulalongkorn Hospital, Bangkok, Thailand</addr-line></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Chulalongkorn Hospital, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Pepin, Stephanie" sort="Pepin, Stephanie" uniqKey="Pepin S" first="Stephanie" last="Pepin">Stephanie Pepin</name><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>sanofi pasteur, Marcy l'Etoile, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>sanofi pasteur, Marcy l'Etoile</wicri:regionArea></affiliation></author><author><name sortKey="Nougarede, Nolwenn" sort="Nougarede, Nolwenn" 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xml:lang="en" level="a" type="main">Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza A/H5N1 Vaccine in Children</title><author><name sortKey="Chotpitayasunondh, Tawee" sort="Chotpitayasunondh, Tawee" uniqKey="Chotpitayasunondh T" first="Tawee" last="Chotpitayasunondh">Tawee Chotpitayasunondh</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>Queen Sirikit National Institute of Child Health, Bangkok, Thailand</addr-line></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Queen Sirikit National Institute of Child Health, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Thisyakorn, Usa" sort="Thisyakorn, Usa" uniqKey="Thisyakorn U" first="Usa" last="Thisyakorn">Usa Thisyakorn</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Chulalongkorn Hospital, Bangkok, Thailand</addr-line></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Chulalongkorn Hospital, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Pancharoen, Chitsanu" sort="Pancharoen, Chitsanu" uniqKey="Pancharoen C" first="Chitsanu" last="Pancharoen">Chitsanu Pancharoen</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Chulalongkorn Hospital, Bangkok, Thailand</addr-line></nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Chulalongkorn Hospital, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Pepin, Stephanie" sort="Pepin, Stephanie" uniqKey="Pepin S" first="Stephanie" last="Pepin">Stephanie Pepin</name><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>sanofi pasteur, Marcy l'Etoile, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>sanofi pasteur, Marcy l'Etoile</wicri:regionArea></affiliation></author><author><name sortKey="Nougarede, Nolwenn" sort="Nougarede, Nolwenn" uniqKey="Nougarede N" first="Nolwenn" last="Nougarede">Nolwenn Nougarede</name><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>sanofi pasteur, Marcy l'Etoile, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>sanofi pasteur, Marcy l'Etoile</wicri:regionArea></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia, Africa and Europe. It has also infected people, especially children, causing severe illness and death. Although the virus shows limited ability to transmit between humans, A/H5N1 represents a potential source of the next influenza pandemic. This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted (Al) and non adjuvanted influenza A/Vietnam/1194/2004 NIBRG-14 (H5N1) vaccine in children.</p></sec><sec><title>Methods and Findings</title><p>In a Phase II, open, randomised, multicentre trial 180 children aged 6 months to 17 years received two injections, 21 days apart, of vaccine containing either: 30 µg haemagglutinin (HA) with adjuvant (30 µg+Al) or 7.5 µg HA without adjuvant. An additional 60 children aged 6–35 months received two “half dose” injections (ie 15 µg+Al or 3.8 µg). Safety was followed for 21 days after vaccination. Antibody responses were assessed 21 days after each injection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30 µg+Al formulation was more immunogenic than 7.5 µg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres ≥32 (1/dil). Among 6–35 month-olds, the full doses were more immunogenic than their half dose equivalents. Vaccination induced a predominantly Th2 response against H5 HA.</p></sec><sec><title>Conclusions</title><p>This influenza A(H5N1) vaccine was well tolerated and immunogenic in children and infants, with Al adjuvant providing a clear immunogenic advantage. These results demonstrate that an H5N1 Al-adjuvanted vaccine, previously shown to be immunogenic and safe in adults, can also be used in children, the group most at risk for pandemic influenza.</p></sec><sec><title>Trial Registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/ct2/show/NCT00491985">NCT00491985</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Poland, G" uniqKey="Poland G">G Poland</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ungchusak, K" uniqKey="Ungchusak K">K Ungchusak</name></author><author><name sortKey="Auewarakul, P" uniqKey="Auewarakul P">P Auewarakul</name></author><author><name sortKey="Dowell, Sf" uniqKey="Dowell S">SF Dowell</name></author><author><name sortKey="Kitphati, R" uniqKey="Kitphati R">R Kitphati</name></author><author><name 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sortKey="Gellin, B" uniqKey="Gellin B">B Gellin</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Stephenson, I" uniqKey="Stephenson I">I Stephenson</name></author><author><name sortKey="Nicholson, Kg" uniqKey="Nicholson K">KG Nicholson</name></author><author><name sortKey="Wood, Jm" uniqKey="Wood J">JM Wood</name></author><author><name sortKey="Zambon, Mc" uniqKey="Zambon M">MC Zambon</name></author><author><name sortKey="Katz, Jm" uniqKey="Katz J">JM Katz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Webby, Rj" uniqKey="Webby R">RJ Webby</name></author><author><name sortKey="Webster, Rg" uniqKey="Webster R">RG Webster</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bresson, Jl" uniqKey="Bresson J">JL Bresson</name></author><author><name sortKey="Perronne, C" uniqKey="Perronne C">C Perronne</name></author><author><name sortKey="Launay, O" uniqKey="Launay O">O 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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19112513</article-id><article-id pub-id-type="pmc">2605261</article-id><article-id pub-id-type="publisher-id">08-PONE-RA-06136</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0004028</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline"><subject>Immunology/Immune Response</subject><subject>Infectious Diseases/Respiratory Infections</subject><subject>Infectious Diseases/Viral Infections</subject><subject>Public Health and Epidemiology/Immunization</subject><subject>Public Health and Epidemiology/Infectious Diseases</subject><subject>Public Health and Epidemiology/Preventive Medicine</subject></subj-group></article-categories><title-group><article-title>Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza A/H5N1 Vaccine in Children</article-title><alt-title alt-title-type="running-head">H5N1 Vaccine in Thai children</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Chotpitayasunondh</surname><given-names>Tawee</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Thisyakorn</surname><given-names>Usa</given-names></name><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pancharoen</surname><given-names>Chitsanu</given-names></name><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pepin</surname><given-names>Stephanie</given-names></name><xref ref-type="aff" rid="aff3"><sup>3</sup></xref><xref ref-type="corresp" rid="cor1"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Nougarede</surname><given-names>Nolwenn</given-names></name><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Queen Sirikit National Institute of Child Health, Bangkok, Thailand</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Chulalongkorn Hospital, Bangkok, Thailand</addr-line></aff><aff id="aff3"><label>3</label><addr-line>sanofi pasteur, Marcy l'Etoile, France</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Schwartz</surname><given-names>Olivier</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1">Institut Pasteur, France</aff><author-notes><corresp id="cor1">* E-mail: <email>stephanie.pepin@sanofipasteur.com</email></corresp><fn fn-type="con"><p>Conceived and designed the experiments: SP NN. Performed the experiments: TC UT CP NN. Analyzed the data: SP NN. Wrote the paper: SP NN. Coordinating Investigator: TC UT CP. Contributed to the interpretation of data and reviewed the draft article and approved the final article: TC UT CP.</p></fn></author-notes><pub-date pub-type="collection"><year>2008</year></pub-date><pub-date pub-type="epub"><day>29</day><month>12</month><year>2008</year></pub-date><volume>3</volume><issue>12</issue><elocation-id>e4028</elocation-id><history><date date-type="received"><day>27</day><month>8</month><year>2008</year></date><date date-type="accepted"><day>30</day><month>10</month><year>2008</year></date></history><permissions><copyright-statement>Chotpitayasunondh et al.</copyright-statement><copyright-year>2008</copyright-year><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.</license-p></license></permissions><abstract><sec><title>Background</title><p>Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia, Africa and Europe. It has also infected people, especially children, causing severe illness and death. Although the virus shows limited ability to transmit between humans, A/H5N1 represents a potential source of the next influenza pandemic. This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted (Al) and non adjuvanted influenza A/Vietnam/1194/2004 NIBRG-14 (H5N1) vaccine in children.</p></sec><sec><title>Methods and Findings</title><p>In a Phase II, open, randomised, multicentre trial 180 children aged 6 months to 17 years received two injections, 21 days apart, of vaccine containing either: 30 µg haemagglutinin (HA) with adjuvant (30 µg+Al) or 7.5 µg HA without adjuvant. An additional 60 children aged 6–35 months received two “half dose” injections (ie 15 µg+Al or 3.8 µg). Safety was followed for 21 days after vaccination. Antibody responses were assessed 21 days after each injection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30 µg+Al formulation was more immunogenic than 7.5 µg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres ≥32 (1/dil). Among 6–35 month-olds, the full doses were more immunogenic than their half dose equivalents. Vaccination induced a predominantly Th2 response against H5 HA.</p></sec><sec><title>Conclusions</title><p>This influenza A(H5N1) vaccine was well tolerated and immunogenic in children and infants, with Al adjuvant providing a clear immunogenic advantage. These results demonstrate that an H5N1 Al-adjuvanted vaccine, previously shown to be immunogenic and safe in adults, can also be used in children, the group most at risk for pandemic influenza.</p></sec><sec><title>Trial Registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/ct2/show/NCT00491985">NCT00491985</ext-link></p></sec></abstract><counts><page-count count="9"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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