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Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine: Results from a double-blinded, randomized Phase I clinical trial in healthy Asian volunteers

Identifieur interne : 001030 ( Main/Merge ); précédent : 001029; suivant : 001031

Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine: Results from a double-blinded, randomized Phase I clinical trial in healthy Asian volunteers

Auteurs : Jenny G. H. Low [Singapour] ; Lawrence S. Lee [Singapour] ; ENG EONG OOI [Singapour] ; Kantharaj Ethirajulu [Singapour] ; Pauline Yeo [Singapour] ; Alex Matter [Singapour] ; John E. Connolly [Singapour] ; David A. G. Skibinski [Singapour] ; Philippe Saudan [Suisse] ; Martin Bachmann [Suisse] ; Brendon J. Hanson [Singapour] ; QINGSHU LU [Singapour] ; Sebastian Maurer-Stroh [Singapour] ; SAM LIM [Singapour] ; Veronica Novotny-Diermayr [Singapour]

Source :

RBID : Pascal:14-0233727

Descripteurs français

English descriptors

Abstract

Methods: A novel, fully bacterially produced recombinant virus-like particle (VLP) based influenza vaccine (gH1-Qbeta) against A/California/07/2009(H1N1) was tested in a double-blind, randomized phase I clinical trial at two clinical sites in Singapore. The trial evaluated the immunogenicity and safety of gH1-Qbeta in the presence or absence of alhydrogel adjuvant. Healthy adult volunteers with no or low pre-existing immunity against A/California/07/2009 (H1N1) were randomized to receive two intramuscular injections 21 days apart, with 100 μg vaccine, containing 42 μg hemagglutinin antigen. Antibody responses were measured before and 21 days after each immunization by hemagglutination inhibition (HAI) assays. The primary endpoint was seroconversion on Day 42, defined as percentage of subjects which reach a HAI titer ≥40 or achieve an at least 4-fold rise in HAI titer (with pre-existing immunity). The co-secondary endpoints were safety and seroconversion on Day 21. Results: A total of 84 Asian volunteers were enrolled in this study and randomized to receive the adjuvanted (n = 43) or the non-adjuvanted (n = 41) vaccine. Of those, 43 and 37 respectively (95%) completed the study. There were no deaths or serious adverse events reported during this trial. A total of 535 adverse events occurred during treatment with 49.5% local solicited symptoms, of mostly (76.4%) mild severity. The most common treatment-related systemic symptom was fatigue. The non-adjuvanted vaccine met all primary and secondary endpoints and showed seroconversion in 62.2% and 70.3% of participants respectively on Day 21 and Day 42. While the adjuvanted vaccine showed an increased seroconversion from 25.5% (Day 21) to 51.2% (Day 42), it did not meet the immunogenicity endpoint.

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Pascal:14-0233727

Le document en format XML

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<name sortKey="Novotny Diermayr, Veronica" sort="Novotny Diermayr, Veronica" uniqKey="Novotny Diermayr V" first="Veronica" last="Novotny-Diermayr">Veronica Novotny-Diermayr</name>
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<title xml:lang="en" level="a">Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine: Results from a double-blinded, randomized Phase I clinical trial in healthy Asian volunteers</title>
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<name sortKey="Bachmann, Martin" sort="Bachmann, Martin" uniqKey="Bachmann M" first="Martin" last="Bachmann">Martin Bachmann</name>
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<name sortKey="Hanson, Brendon J" sort="Hanson, Brendon J" uniqKey="Hanson B" first="Brendon J." last="Hanson">Brendon J. Hanson</name>
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<s1>DSO National Laboratories, Bio-Defense Therapeutics Lab, 27 Medical Drive</s1>
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<name sortKey="Qingshu Lu" sort="Qingshu Lu" uniqKey="Qingshu Lu" last="Qingshu Lu">QINGSHU LU</name>
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<name sortKey="Maurer Stroh, Sebastian" sort="Maurer Stroh, Sebastian" uniqKey="Maurer Stroh S" first="Sebastian" last="Maurer-Stroh">Sebastian Maurer-Stroh</name>
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</author>
<author>
<name sortKey="Sam Lim" sort="Sam Lim" uniqKey="Sam Lim" last="Sam Lim">SAM LIM</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>D3 (Drug Discovery and Development), 31 Biopolis Way, #01-02a Nanos</s1>
<s2>Singapore 138669</s2>
<s3>SGP</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Singapour</country>
<wicri:noRegion>Singapore 138669</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Novotny Diermayr, Veronica" sort="Novotny Diermayr, Veronica" uniqKey="Novotny Diermayr V" first="Veronica" last="Novotny-Diermayr">Veronica Novotny-Diermayr</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>D3 (Drug Discovery and Development), 31 Biopolis Way, #01-02a Nanos</s1>
<s2>Singapore 138669</s2>
<s3>SGP</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Singapour</country>
<wicri:noRegion>Singapore 138669</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<imprint>
<date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Immunogenicity</term>
<term>Influenza</term>
<term>Influenza A virus</term>
<term>Influenzavirus A(H1N1)</term>
<term>Phase I trial</term>
<term>Vaccine</term>
<term>Virus like particle</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Virus grippal A</term>
<term>Immunogénicité</term>
<term>Particule type viral</term>
<term>Vaccin</term>
<term>Essai clinique phase I</term>
<term>Grippe</term>
<term>Virus grippal A(H1N1)</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Vaccin</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Methods: A novel, fully bacterially produced recombinant virus-like particle (VLP) based influenza vaccine (gH1-Qbeta) against A/California/07/2009(H1N1) was tested in a double-blind, randomized phase I clinical trial at two clinical sites in Singapore. The trial evaluated the immunogenicity and safety of gH1-Qbeta in the presence or absence of alhydrogel adjuvant. Healthy adult volunteers with no or low pre-existing immunity against A/California/07/2009 (H1N1) were randomized to receive two intramuscular injections 21 days apart, with 100 μg vaccine, containing 42 μg hemagglutinin antigen. Antibody responses were measured before and 21 days after each immunization by hemagglutination inhibition (HAI) assays. The primary endpoint was seroconversion on Day 42, defined as percentage of subjects which reach a HAI titer ≥40 or achieve an at least 4-fold rise in HAI titer (with pre-existing immunity). The co-secondary endpoints were safety and seroconversion on Day 21. Results: A total of 84 Asian volunteers were enrolled in this study and randomized to receive the adjuvanted (n = 43) or the non-adjuvanted (n = 41) vaccine. Of those, 43 and 37 respectively (95%) completed the study. There were no deaths or serious adverse events reported during this trial. A total of 535 adverse events occurred during treatment with 49.5% local solicited symptoms, of mostly (76.4%) mild severity. The most common treatment-related systemic symptom was fatigue. The non-adjuvanted vaccine met all primary and secondary endpoints and showed seroconversion in 62.2% and 70.3% of participants respectively on Day 21 and Day 42. While the adjuvanted vaccine showed an increased seroconversion from 25.5% (Day 21) to 51.2% (Day 42), it did not meet the immunogenicity endpoint.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Singapour</li>
<li>Suisse</li>
</country>
<orgName>
<li>Université nationale de Singapour</li>
</orgName>
</list>
<tree>
<country name="Singapour">
<noRegion>
<name sortKey="Low, Jenny G H" sort="Low, Jenny G H" uniqKey="Low J" first="Jenny G. H." last="Low">Jenny G. H. Low</name>
</noRegion>
<name sortKey="Connolly, John E" sort="Connolly, John E" uniqKey="Connolly J" first="John E." last="Connolly">John E. Connolly</name>
<name sortKey="Eng Eong Ooi" sort="Eng Eong Ooi" uniqKey="Eng Eong Ooi" last="Eng Eong Ooi">ENG EONG OOI</name>
<name sortKey="Ethirajulu, Kantharaj" sort="Ethirajulu, Kantharaj" uniqKey="Ethirajulu K" first="Kantharaj" last="Ethirajulu">Kantharaj Ethirajulu</name>
<name sortKey="Hanson, Brendon J" sort="Hanson, Brendon J" uniqKey="Hanson B" first="Brendon J." last="Hanson">Brendon J. Hanson</name>
<name sortKey="Lee, Lawrence S" sort="Lee, Lawrence S" uniqKey="Lee L" first="Lawrence S." last="Lee">Lawrence S. Lee</name>
<name sortKey="Lee, Lawrence S" sort="Lee, Lawrence S" uniqKey="Lee L" first="Lawrence S." last="Lee">Lawrence S. Lee</name>
<name sortKey="Low, Jenny G H" sort="Low, Jenny G H" uniqKey="Low J" first="Jenny G. H." last="Low">Jenny G. H. Low</name>
<name sortKey="Matter, Alex" sort="Matter, Alex" uniqKey="Matter A" first="Alex" last="Matter">Alex Matter</name>
<name sortKey="Maurer Stroh, Sebastian" sort="Maurer Stroh, Sebastian" uniqKey="Maurer Stroh S" first="Sebastian" last="Maurer-Stroh">Sebastian Maurer-Stroh</name>
<name sortKey="Novotny Diermayr, Veronica" sort="Novotny Diermayr, Veronica" uniqKey="Novotny Diermayr V" first="Veronica" last="Novotny-Diermayr">Veronica Novotny-Diermayr</name>
<name sortKey="Qingshu Lu" sort="Qingshu Lu" uniqKey="Qingshu Lu" last="Qingshu Lu">QINGSHU LU</name>
<name sortKey="Sam Lim" sort="Sam Lim" uniqKey="Sam Lim" last="Sam Lim">SAM LIM</name>
<name sortKey="Skibinski, David A G" sort="Skibinski, David A G" uniqKey="Skibinski D" first="David A. G." last="Skibinski">David A. G. Skibinski</name>
<name sortKey="Yeo, Pauline" sort="Yeo, Pauline" uniqKey="Yeo P" first="Pauline" last="Yeo">Pauline Yeo</name>
</country>
<country name="Suisse">
<noRegion>
<name sortKey="Saudan, Philippe" sort="Saudan, Philippe" uniqKey="Saudan P" first="Philippe" last="Saudan">Philippe Saudan</name>
</noRegion>
<name sortKey="Bachmann, Martin" sort="Bachmann, Martin" uniqKey="Bachmann M" first="Martin" last="Bachmann">Martin Bachmann</name>
</country>
</tree>
</affiliations>
</record>

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